The safety and scientific validity of each study registered on the ANZCTR is the responsibility of the study sponsor and investigators. Listing a study on the ANZCTR does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to information for consumers

Number of records retrieved: 154



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Trial from ANZCTR

Managing Chronic Symptoms in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome using Insights from N-of-1 Studies: A Series of N-of-1 Observational Studies

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 22/11/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12618001898246

Date registered

22 November 2018

Health condition

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Recruitment countries

Australia

Recruitment site location(s) (State)

Queensland, Victoria

Recruitment status

Recruiting

Anticipated date of first participant enrolment

n/a

Ethics application status

Approved

Brief summary

This research study aims to explore intra-individual variability in symptoms over time and intra-individual predictors of symptom severity. A series of n-of-1 observational studies with individuals with ME/CFS will be conducted. The study also aims to assess the acceptability and feasibility of participating in n-of-1 observational studies from the perspective of individuals with ME/CFS. This will be achieved by conducting semi-structured interviews with participants at the end of the study and by examining participant adherence to study procedures (e.g. questionnaire completion rates).

Eligibility

Key inclusion criteria

Adults 18 years or older with a medical diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Individuals are not excluded on the basis of their gender, age or overall health status.

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

Key exclusion criteria

Individuals under 18 years old. Individuals who have not received a medical diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Contact details and further information

Primary Sponsor

Type: University
Name: The University of Queensland
Address: UQ Centre for Clinical Research
Building 71/918
Royal Brisbane & Women's Hospital Campus
Herston, QLD, 4029
Country: Australia

Contact person for information and recruitment

Dr Suzanne McDonald
UQ Centre for Clinical Research,
The University of Queensland,
Building 71/918,
Royal Brisbane & Women's Hospital Campus,
Herston,
Queensland,
4029
Australia
+61733465025
suzanne.mcdonald@uq.edu.au



Trial from ANZCTR

A 6-month aquatic exercise programme for individuals with CFS/ME: benefits for symptoms, health and physical capacity

  • Recruitment status at the time of last update
    Not yet recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 12/10/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12618001683224

Date registered

12 October 2018

Health condition

Myalgic Encephalomyelitis, Chronic Fatigue Syndrome

Recruitment countries

Australia

Recruitment site location(s) (State)

New South Wales, Queensland

Recruitment status

Not yet recruiting

Anticipated date of first participant enrolment

28 January 2019

Ethics application status

Approved

Brief summary

The study will investigate the effectiveness of six months of self-paced aquatic exercise for individuals with CFS/ME, compared to usual care (control group). Outcome measures will include physical capacity (resting heart rate, resting blood pressure, oxygen saturation, perceived exertion (RPE), 6 minute walk test, hand grip strength, sit to stand test, sit and reach test, and the Apley's shoulder test); health and symptoms (full blood test with white cell differential, assessment of orthostatic blood pressure, FACIT fatigue and tiredness scale, and a VAS Pain scale); and quality of life (SF-36 Quality of Life; Hospital Anxiety and Depression Scale [HADS], surveys, and open-ended questions in interviews).

Participants will be allocated to an exercise or control group, and supervised, self-paced exercise sessions will be held twice a week in a heated pool. The results will be applicable to all age groups who suffer CFS/ME, with or without FM.
This is a proof-of-concept study with a view to conducting a larger, longitudinal trial to provide further evidence for clinical practice.
It is hypothesized that (1) the aquatic exercise group will improve their exercise tolerance, physiological responses and quality of life, and reduce symptoms of fatigue, pain and anxiety compared to the control group; (2) the number of immune cells (leukocytes) will increase in the exercise group compared to the control group.

Eligibility

Key inclusion criteria

(1) Age range of 18-80 years
(2) GP diagnosis of CFS &/or ME, Post Viral Syndrome, Post Viral Fatigue Syndrome or Chronic Mononucleosis by means of the Canadian Consensus criteria or the Fukuda criteria
(3) Does not currently participate in regular vigorous exercise or physical activity
(4) Is able to communicate in English
(5) Able to give informed, signed consent
(6) Able to commit the time required for participating in this research

Minimum age

18 Years

Maximum age

80 Years

Gender

Both males and females

Key exclusion criteria

(1) Cardiovascular condition that makes physical activity hazardous
(2) Severe chronic obstructive pulmonary disease or uncontrolled asthma
(3) A diagnosed medical condition other than CFS/ME which causes chronic or severe fatigue
(4) Metabolic, renal, endocrine, autoimmune, neurological or inflammatory disease that makes physical activity hazardous
(5) A current musculoskeletal injury that prevents physical activity
(6) Mental illness that makes participation in this research hazardous
(7) Infectious diseases
(8) Non-swimmer
(9) Allergic to chlorine or other pool chemicals
(10) Pregnant

Contact details and further information

Primary Sponsor

Type: University
Name: Southern Cross University
Address: Military Road, East Lismore, NSW 2480
or
PO Box 157, Lismore, NSW, 2480
Country: Australia

Contact person for information and recruitment

Dr Sonja Coetzee
Southern Cross University
School of Health and Human Sciences
Military Rd, East Lismore 2480
Office P1.48
or
PO Box 157, Lismore, NSW, 2480

Australia
+61 2 6626 9290
sonja.coetzee@scu.edu.au



Trial from ANZCTR

The effects of a glial inhibitor (palmitoylethanolamide) on brain function and chronic pain intensity in subjects with orofacial neuropathic pain. A pilot study.

  • Recruitment status at the time of last update
    Not yet recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 3/10/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12618001637235

Date registered

03 October 2018

Health condition

Persistent orofacial/ trigeminal neuropathic pain

Recruitment countries

Australia

Recruitment site location(s) (State)

New South Wales

Recruitment status

Not yet recruiting

Anticipated date of first participant enrolment

10 October 2018

Ethics application status

Approved

Brief summary

This study entails understanding the effects of palmitoylethanolamide on pain and brain activity. We hope to learn whether palmitoylethanolamide (a natural compound found in certain foods) reduces on-going pain in the face and how this is reflected in changes in brain anatomy and function. Participants will undergo initial screening which involves questionnaires and a 2 ml blood sample, then scanned using an MRI. Participants will then be assigned either the active drug or a placebo for a total of six weeks and asked to rate their pain daily for the entire period. After six weeks, participants will redo the questionnaires, provide another 2 ml of blood and be scanned using an MRI. We believe that after six weeks of treatment, patients will experience a decrease in pain intensity and MRI scans will show changes in anatomy and function that reflect the decreases in pain.

Eligibility

Key inclusion criteria

Subjects with a diagnosis of orofacial / trigeminal neuropathic pain for longer than 3 months duration
Aged over 18 years old
Willingness to give written informed consent, willingness to complete a magnetic resonance imaging study, complete various questionnaires and to have a blood sample taken

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

Key exclusion criteria

Taking daily analgesic medications such as aspirin, ibuprofen, gabapentin, serotonin reuptake inhibitors, anti-depressants for any conditions within 24 hours of study initiation.
Claustrophobia
Standard MRI exclusion criteria such as the presence of a cardiac pacemaker, artificial heart valve, blood vessel stents, aneurysm clips, cochlear implants, prosthetic devices, magnetically activated implant or device and pregnancy.
History of psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study.

Contact details and further information

Primary Sponsor

Type: University
Name: University of Sydney
Address: The University of Sydney
NSW 2006
Australia
Country: Australia

Contact person for information and recruitment

Prof Luke Henderson
Room S518
Anderson Stuart Building, F13
The University of Sydney
NSW 2006 AUSTRALIA

Australia
+61 293517063
luke.henderson@sydney.edu.au



Trial from ANZCTR

For people with Dupuytren's disease of the hand, is treatment with percutaneous fasciotomy as effective as injectable collagenase in improving functionality and fixed flexure angles.

  • Recruitment status at the time of last update
    Not yet recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 23/7/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12618001240235

Date registered

23 July 2018

Health condition

Dupuytrens disease

Recruitment countries

Australia

Recruitment site location(s) (State)

Tasmania

Recruitment status

Not yet recruiting

Anticipated date of first participant enrolment

03 September 2018

Ethics application status

Approved

Brief summary

This study aims to compare two treatments for the management of Dupuytren's disease of the hand. The two treatments can both be performed in the surgeons rooms without requiring a major surgical procedure. The two treatments are 1) the use of a needle to divide the tissue causing the contracture, and 2) the use of a chemical substance to break down the tissue causing the contracture. The hypothesis of this study is that the use of needle is as effective as the use of a chemical substance, and less expensive.

Eligibility

Key inclusion criteria

Dupuytren’s disease with contracture (20-100 degrees Metacarpo-phalyngeal (MCP) joint or 20-80 at the proximal interphalyngeal (PIP) joint.)
Consulting clinician deems it appropriate management for the patient to have one or other of the fasciotomy procedures
No previous treatment within 90 days
Able to provide informed consent; age 18 years and older

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

Key exclusion criteria

Bleeding disorder, blood thinning treatment (except aspirin 150mg/day)
Allergy to collagenase ; pregnancy, breast feeding; neuromuscular disorders
Administration of tetracyclines, antracyclines or anthraquinones in the past 14 days (these meds inhibit matrix metalloproteinase-mediate collagen degradation at suprapharmacological concentrations in vitro).

Contact details and further information

Primary Sponsor

Type: Hospital
Name: Launceston General Hospital
Address: 274-280 Charles Street
Launceston Tasmania 7250

Country: Australia

Contact person for information and recruitment

Dr Kathryn Ogden
Launceston Clinical School
University of Tasmania
Level 2, Northern Integrated Care Service
41 Frankland Street
Launceston, Tasmania, 7250

Australia
+ 61 3 6777 8790
kathryn.ogden@utas.edu.au



Trial from ANZCTR

Epidemiology of Multiple Somatic Symptoms in the community, and its association with illness related cognitions`

  • Recruitment status at the time of last update
    Not yet recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 11/10/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12618000907246

Date registered

30 May 2018

Health condition

Multiple Somatic Symptoms , Somatic Symptom Disorder, Somatisation, Health Anxiety

Recruitment countries

Australia

Recruitment site location(s) (State)

New South Wales

Recruitment status

Not yet recruiting

Anticipated date of first participant enrolment

06 March 2019

Ethics application status

Approved

Brief summary

Multiple somatic symptoms (MSS) can be defined as a range of non-specific symptoms such as musculoskeletal pain, fatigue and abdominal pain, and are expressed in the absence of any clear pathology.

MSS is measured on scale. Those who score highly on that scale are associated with a reduced quality of life and substantial increase in healthcare utilisation.

By way of example, disorders such as Somatization Disorder (Diagnostic and Statistical Manual of Mental Disorders-V), fibromyalgia, chronic fatigue syndrome, functional Gastrointestinal disorders and multiple chemical sensitivity have all been associated with MSS.

This study focuses on MSS, rather than specific diseases or only a few symptoms. It is important to do so, as MSS is considered to be a predictor of negative health consequences, independent of other chronic diseases or psychopathology. For the present study, MSS are identified using the Patient Health Questionnaire-15.

At present a large proportion of Australians seek help for MSS, which places a burden on generalist and specialist services. In addition, the natural course of MSS is unfortunately unfavourable (meaning that symptoms suffered by people with MSS are less likely to resolve with time). By way of comparison, MSS stability rates are as high as depressive disorders and higher than anxiety disorders.

However, to date, limited research of MSS has been conducted in an Australian community setting. Identifying, the prevalence of MSS in the community and related psychological predictors of its development and maintenance remains an important health priority.

The present study seeks to address the following aims:
1. To determine the incidence and prevalence of MSS in an Australian community setting and its relationship with co-morbid chronic diseases, specific illness related cognitions and psychological distress.
2. To determine the stability of MSS over the course of 1 year.
3. To suggest potential psychosocial aetiologies for MSS by studying mind-body and body-mind interactions in these conditions.

Eligibility

Key inclusion criteria

Random selection of community individuals from NSW electorates (Bradfield, Bennelong, North Sydney, Sydney, Grayndler, Reid, Parramatta and Mitchell)

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

Key exclusion criteria

Non-response to survey

Contact details and further information

Primary Sponsor

Type: University
Name: Macquarie University
Address: Balaclava Road, Macquarie University, North Ryde, 2109 NSW
Country: Australia

Contact person for information and recruitment

Mr David McNaughton
Balaclava Road, Macquarie University, North Ryde 2109 NSW
Department of Psychology
Australia
+61 2 9850 8601
david.mcnaughton@hdr.mq.edu.au



Trial from ANZCTR

Evaluating the validity of urinary kryptopyrrole (UKP) testing - quantifying UKP levels in a healthy adult population compared to people diagnosed with anxiety.

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 5/9/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12618000032257

Date registered

12 January 2018

Health condition

Pyrrole disorder / pyroluria

Recruitment countries

Australia

Recruitment site location(s) (State)

Queensland

Recruitment status

Recruiting

Anticipated date of first participant enrolment

15 January 2018

Ethics application status

Approved

Brief summary

This study seeks to establish a reference range for a urinary kryptopyrrole test produced and conducted by SAFE Analytical Laboratories Pty Ltd ("the test"), This study is aiming to provide suitable data to enable registration of the test on the Australian Register of Therapeutic Goods (ARTG). Four parts to this study have been designed to correlate the urinary kryptopyrrole levels with health and disease states as observed in adult populations.

Eligibility

Key inclusion criteria

Arm 2
* Healthy adults aged 18 or more years
* No current diagnosed health conditions
* Not currently pregnant or breastfeeding

Arm 3
* Adults aged 18 or more years
* Diagnosed with anxiety.
* Not currently pregnant or breastfeeding

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

Key exclusion criteria

Any currently diagnosed health condition.
Pregnant and/or breastfeeding.

Contact details and further information

Primary Sponsor

Type: University
Name: Endeavour College of Natural Health Office of Research
Address: 269 Wickham Street
Fortitude Valley Qld 4006
Country: Australia

Contact person for information and recruitment

Dr Janet Schloss
Level 2, Endeavour College of Natural Health Office of Research
269 Wickham Street
Fortitude Valley Qld 4006
Australia
+61 7 3253 9579
janet.schloss@endeavour.edu.au



Trial from ANZCTR

A cross-sectional health survey of 407 women associated with Universal Medicine

  • Recruitment status at the time of last update
    Completed
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 6/7/2017)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12617000972325

Date registered

06 July 2017

Health condition

BMI, Stress, Depression, Summary Mental Health, Abnormal pap test, Low iron, Abnormal mammogram, Asthma, Bronchitis / Emphysema, Breast cancer, Cervical cancer, Heart disease, Osteoporosis, Skin cancer, Stroke, Diabetes, Hypertension, Thrombosis, Back pain

Recruitment countries

Australia, New Zealand, United Kingdom, Portugal, Germany, Belgium, Japan, Netherlands, Norway, United States of America, Switzerland, Canada, Hong Kong, Singapore, Spain, Colombia

Recruitment site location(s) (State)

Australian Capital Territory, New South Wales, Northern Territory, Queensland, South Australia, Tasmania, Western Australia, Victoria

Recruitment status

Completed

Anticipated date of first participant enrolment

n/a

Ethics application status

Approved

Brief summary

The current study is part of a larger quantitative, cross-sectional survey of women. A sample of 461 female UM participants from 17 countries responded to 43 questions taken from the Australian Longitudinal Study of Women’s Health (ALSWH). The survey compared health indicators for UM participants with those of ALSWH respondents.

Eligibility

Key inclusion criteria

Participant in Universal Medicine workshops and lectures

Minimum age

18 Years

Maximum age

No limit

Gender

Females

Key exclusion criteria

No consent

Contact details and further information

Primary Sponsor

Type: Individual
Name: Christoph Schnelle
Address: University of Queensland
Herston Road
Herston QLD 4007
Country: Australia

Contact person for information and recruitment

Mr Christoph Schnelle
School of Public Health, Faculty of Medicine
University of Queensland
Herston Road
Herston QLD 4007
Australia
+61266244242
christoph.schnelle@uq.net.au



Trial from ANZCTR

A double-blind randomized sham-controlled trial to evaluate the effect of prefrontal Theta Burst Stimulation on severity and impact of pain in patients with fibromyalgia

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 16/7/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12617000487314

Date registered

04 April 2017

Health condition

Fibromyalgia

Recruitment countries

Australia

Recruitment site location(s) (State)

Victoria

Recruitment status

Recruiting

Anticipated date of first participant enrolment

01 May 2017

Ethics application status

Approved

Brief summary

The proposed study aims to conduct a double-blind, randomized, sham-controlled proof of principle trial to establish the efficacy of Theta Burst Stimulation (TBS) treatment in fibromyalgia. Fibromyalgia and related disorders present a substantial health problem, with current treatments limited in their efficacy and associated with a number of side effects. This study will explore for the first time in fibromyalgia a novel non-pharmaceutical intervention, TBS; a non-invasive brain stimulation method. TBS is a powerful new alternative to standard non-invasive brain stimulation methods as it can be applied in a much more time efficient manner and may result in greater clinical benefit. If successful, the application of this method for fibromyalgia may be applicable to related disorders such as Chronic Fatigue Syndrome.

This is a randomised sham-controlled trial study, in which 52 participants with a diagnosis of fibromyalgia will be recruited. Participants will be randomised into one of two conditions- (1) Active TBS condition and (2) Sham (or ‘placebo’) TBS condition. Participants will have two weeks of twice daily stimulation followed by a tapered two week dose of twice daily treatments on Monday, Wednesday and Friday only. Participants will be asked to a number of self-report questionnaires at baseline, at the end of each treatment week (weeks 1-4) and at the 1 month follow up appointment, as well as will undergo the collection of neurobiological data (TMS-EEG) at baseline, end of week 4 and follow-up.

Eligibility

Key inclusion criteria

Inclusion Criteria: patients will be included if they:
- have a current diagnosis of fibromyalgia
- aged between 18 and 75 years
- have had no increase or initiation of new medication therapy in the four weeks prior to study screen

Minimum age

18 Years

Maximum age

75 Years

Gender

Both males and females

Key exclusion criteria

Exclusion Criteria: Participants who:
- Patients who have an unstable medical condition, neurological disorder or any history of seizure disorder or are currently pregnant or lactating
- The presence of metal anywhere in the head, except the mouth, which may interfere with the magnetic field
- Have a current DSM-V diagnosis of Substance Abuse or Dependence disorder, or another psychiatric condition. This excludes depression, PTSD or anxiety unless they are the primary disorder (i.e. fibromyalgia is not the primary disorder).

Contact details and further information

Primary Sponsor

Type: Individual
Name: Dr Bernadette Fitzgibbon
Address: Monash Alfred Psychiatry Research Center,
Level 4, 607 St Kilda Road
Melbourne 3004 VIC
Country: Australia

Contact person for information and recruitment

Dr Bernadette Fitzgibbon
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Road
Melbourne VIC 3004
Australia
+61 3 9076 9860
bernadette.fitzgibbon@monash.edu



Trial from ANZCTR

The temporal relationship of the effects of repeated exercise on physiological variables in individuals with Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME

  • Recruitment status at the time of last update
    Not yet recruiting
  • What is the status of the ethics application?
    Ethics status: Not yet submitted
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
    (provisional)
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 27/2/2017)
  • Ethics status: Not yet submitted
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12617000299303p

Date registered

27 February 2017

Health condition

Chronic Fatigue Syndrome, Myalgic Encephalomyelitis

Recruitment countries

New Zealand

Recruitment status

Not yet recruiting

Anticipated date of first participant enrolment

01 May 2017

Ethics application status

Not yet submitted

Brief summary

Provide innovative information on the temporal relationship of physiological responses (oxygen consumption, carbon dioxide production, anaerobic threshold, cardiac output, heart rate, power output, and blood pressure), inflammation and cognitive functioning in CFS/ME patients following repeated cardiopulmonary exercise testing at 48 and 72 hours.

Design: Randomised controlled trial with CFS/ME randomised to either 48 or 72 hour repeat testing and age matched healthy controls.
Recruitment: Participants will be recruited through the national organisation (ANZMES) via flyers and mail out to patients as well as identified through a database of existing CFS/ME from previous studies. Upon making contact and showing interest potential participants complete the online De Paul Symptom Questionnaire. This will be analysed to ensure participants meet the CFS International, Canadian and Fukuda criteria for diagnosis of CFS.

Participants: 60 participants will be recruited, 30 CFS/ME, and 30 matched healthy controls will be recruited. Testing will take place in Massey University's Exercise and Sport Science mobile lab. Individuals will be matched with control subjects for age, body mass and activity levels and will be free from non-communicable diseases. All participants will give written informed consent.

Pre-exercise measures: All individuals will undergo endothelial function assessment by pulse wave velocity and analysis (via SphygmaCor). Individuals will then provide a 20ml venous blood sample (cytokine assessment). Following this, individuals will have their resting blood pressure, height and weight recorded and heart rate variability measured. Individuals will then undertake neuropsychological testing via the stroop, trail, substitution and choice tests to test their pre exercise cognitive function.

Exercise testing: A validated incremental cycle ergometer exercise test designed to peak at work rates in 8-12 minutes. Participants will maintain 60-80 rpm throughout the test and will be encouraged to participate for as long as possible. The workload will be increased at a rate of 5 watts/20 second. Breath by breath gas samples will be collected throughout the exercise test via metabolic cart. Participants will then remain seated on the cycle ergometer and monitored for 2-5 minutes for recovery. Heart rate and rating of perceived exertion will be measured during each minute of the test and blood pressure manually every two minutes. Following a 20-minute period of rest, cardiac output will be measured through a non-invasive rebreathing technique and will require participants to cycle for up to five minutes at a set resistance at their respiratory exchange ratio.

Post-exercise measures: Exercise recovery questionnaire as used by Davenport et al., 2010 will be completed. This allows participants to report symptoms following their exercise test, until complete recovery. We will record symptoms of fatigue each 24 hours for 7 days

Eligibility

Key inclusion criteria

CFS/ME individuals will need to meet the International Consensus Criteria, Canadian Criteria and Fukuda case definition. These involve 3 major inclusion points, >6 months of severe fatigue, significant reductions in day to day functionality and the presence of 4 out of 8 major symptoms.
Healthy volunteers will be age, gender and fitness match and will be free from disease.

Minimum age

18 Years

Maximum age

75 Years

Gender

Both males and females

Key exclusion criteria

Depressive disorders, individuals who have a known disease unrelated to Chronic Fatigue Syndrome/ME.
Healthy volunteers will be free from disease.

Contact details and further information

Primary Sponsor

Type: University
Name: Massey University
Address: Research and Development Office
Private bag 11-222
Palmerston North
4442
Country: New Zealand

Contact person for information and recruitment

Dr Lynette Hodges
School of Sport and Exercise
College Health
Massey University
Private Bag 11-222
Palmerston North
4442

New Zealand
+64 6 356 9099
l..d.hodges@massey.ac.nz



Trial from ANZCTR

Personalised relaxation practice to improve sleep and functioning in patients with chronic fatigue syndrome and depression: A Randomised Control Trial

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 8/1/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12616001671459

Date registered

05 December 2016

Health condition

Chronic Fatigue Syndrome, Depression

Recruitment countries

Australia

Recruitment site location(s) (State)

New South Wales

Recruitment status

Recruiting

Anticipated date of first participant enrolment

01 April 2017

Ethics application status

Approved

Brief summary

Debilitating fatigue; unrefreshing sleep and poor daytime functioning are core features of many neuropsychiatric conditions including chronic fatigue syndrome (CFS) and major depression. Understanding of the aetiologies of these conditions is still incomplete and symptom management strategies have only limited efficacy.
Accumulating evidence suggests that abnormalities in the function of the autonomic nervous system play a role in the sleep disturbance and chronic fatigue in these conditions. In particular, autonomic activity is characterized by neural hyper-vigilance and a marked loss of parasympathetic, vagus nerve activity that persist even during sleep. Measures of beat-to-beat heart rate variability (HRV) provide well-established, reliable indices of autonomic functioning, which consistently correlate with the severity and outcome of a spectrum of fatiguing disorders, including autoimmune and cardiovascular disease, chronic pain, depression, and CFS . For example, low HRV was repeatedly found to be a strong correlate of unrefreshing sleep, daytime fatigue and cognitive impairment in CFS.
Mindfulness-based stress reduction and relaxation methods are increasingly utilised with the aim to restore autonomic balance. It is believed that the beneficial effects of these approaches are mediated via their impact on neural circuits involved in self-regulation, and on key stress-response pathways. However, individuals can have very different responses to different relaxations methods; and recent analyses revealed that some patients do not respond optimally to some.
The main of the current study is to conduct a randomized control trial (RCT) to determine the efficacy and specific benefits of a 4 week personalised relaxation intervention, pre-tested to optimise the individuals' own HRV. Subjective health outcomes and parasympathetic autonomic activity (indexed by HRV) in patients with CFS and depression will be compared to a ‘monitoring only’ control condition. We anticipate that daily practice of a personalised relaxation method before sleep will be substantively more effective in improving sleep quality, daytime fatigue and functioning in both patient groups compared to treatment as usual with symptom monitoring. We further anticipate that restoration of HRV will contribute to positive health outcomes. The findings from this research will facilitate a better understanding of the pathophysiological mechanisms operating in chronic fatigue conditions.

Eligibility

Key inclusion criteria

Meet international diagnostic criteria for chronic fatigue syndrome; or DSM-V diagnostic criteria for depression; Normal or corrected to normal hearing; Sufficient English to complete the questionnaires and follow the guided relaxation tasks; Willingness and ability to give written informed consent and willingness to participate and comply with the longitudinal nature study.

Minimum age

18 Years

Maximum age

65 Years

Gender

Both males and females

Key exclusion criteria

Pregnant; Other significant illness or major diagnoses such as primary sleep disorder, heart conditions, uncontrolled diabetes, chronic infections, or psychotic disorders; Taking regular medications that affect autonomic activity including beta-blockers/anti-hypertensives; concurrently engaged in other psycho-behavioural interventions. Use of anti-depressants or the oral-contraceptive pill will be recorded but not exclusionary.

Contact details and further information

Primary Sponsor

Type: University
Name: University of New South Wales
Address: UNSW Australia, High Street, Kensington, NSW, 2052
Country: Australia

Contact person for information and recruitment

A/Prof Ute Vollmer-Conna
Level 1, 30 Botany Street,UNSW, Sydney, NSW, 2052
Australia
+610293852942
human.behav@unsw.edu.au



Trial from ANZCTR

Effectiveness of Cognitive Behavior Therapy for Post-Stroke Fatigue and Sleep Disturbance: a Pilot Randomised Controlled Trial

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Retrospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 1/9/2016)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12616001211459

Date registered

01 September 2016

Health condition

Stroke, Fatigue, Sleep disturbance

Recruitment countries

Australia

Recruitment site location(s) (State)

Victoria

Recruitment status

Recruiting

Anticipated date of first participant enrolment

n/a

Ethics application status

Approved

Brief summary

Fatigue occurs in around 50% of individuals post-stroke often co-existing with sleep problems, which contribute to fatigue. Fatigue is further correlated with cognitive and functional disability and is associated with depression, anxiety, pain, sleep disturbance, unemployment and reduced quality of life. Despite this, there has been little empirical investigation into the management of fatigue and sleep disturbance following stroke and no treatments are indicated for use following stroke. Pharmacotherapy is ineffective in the long-term and may cause adverse effects. Graded exercise has shown modest gains in fatigue post-stroke. A review of chronic fatigue syndrome treatment studies concluded graded exercise and CBT were effective, but CBT was more effective where anxiety and depression were also present. To date there have been no controlled trials of CBT addressing fatigue and sleep disturbance following stroke. If successful, CBT for fatigue and sleep will result in reductions in fatigue, improved sleep quality, increased activity levels and thus improved quality of life and functional outcomes.

Eligibility

Key inclusion criteria

Participants aged 17 to 70 years with history of stroke and clinically significant self-reported fatigue (Fatigue Severity Scale [FSS] equal or above 4) and/or poor sleep (Pittsburgh Sleep Quality Index [PSQI] above 5). They need to have adequate English skills, cognitive ability, visual acuity and physical ability to complete the questionnaires and therapy, as assessed by their treating neuropsychologist and live within a one-hour radius of the hospital.

Minimum age

17 Years

Maximum age

70 Years

Gender

Both males and females

Key exclusion criteria

Exclusion criteria are co-morbid neurological disorders, acute psychiatric symptoms or substance abuse, transmeridian travel or night shift work in the previous month and current sleep apnea.

Contact details and further information

Primary Sponsor

Type: Individual
Name: Jennie Ponsford
Address: School of Psychological Sciences, Monash University
Monash Institute of Cognitive and Clinical Sciences (MICCN)
18 Innovation Walk
Monash University, Clayton, 3800
Victoria, Australia
Country: Australia

Contact person for information and recruitment

Miss Sylvia Nguyen
Monash-Epworth Rehabilitation Research Centre
185-187 Hoddle St Richmond VIC 3121
Australia
+61 3 94268923
sylvia.nguyen@monash.edu



Trial from ANZCTR

Allostasis and Sedation Practices in Intensive Care Evaluation (All-SPICE) - A substudy of a Randomised multi-centre Sedation Practices in Intensive Care Evaluation (SPICE-III) study, to determine the effect of sedation medications on levels of physiological stress

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 26/9/2017)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12616001200471

Date registered

31 August 2016

Health condition

Multi-Organ Failure, Shock, Critical Illness

Recruitment countries

Australia

Recruitment site location(s) (State)

New South Wales, Queensland

Recruitment status

Recruiting

Anticipated date of first participant enrolment

01 September 2016

Ethics application status

Approved

Brief summary

The survival of an organism in the face of internal and external events requires a measured and appropriate stress response. It has been hypothesised that an abnormal stress response is linked to the likelihood of the development and severity of critical illness and multi-organ failure. The stress response is coordinated by the primitive brain structures of the diencephalon and brainstem in response to somatosensory inputs and comprises a broad range of neuro-hormonal and immune effects. We hypothesise that the use of sedating medications confuses the normal generation of a stress response. If this is confirmed, this may be a fundamental underlying cause for the abnormal haemodynamics, metabolic disturbances and organ dysfunction observed in critical illness.
The large multi-centre randomised-controlled SPICE-III study offers the opportunity to study two similar groups of patients who may have differing levels of physiological stress as a result of an Early Goal-Directed Sedation (EGDS) strategy as compared to standard care.
We aim to conduct a substudy to determine whether a strategy of EGDS and the resultant reduced sedation level results in a differing physiological stress response in critically unwell patients as measured by a panel of blood-borne markers.
We hypothesise that the application of an early goal directed sedation protocol and the resultant reduced sedation level in the first 5 days of critical illness will result in a differing pattern of stress as measured by metabolic, sympathetic, hormonal and inflammatory responses.

All-SPICE will be a prospective parallel-group multi-centre observational sub-study of the the SPICE-III study. The SPICE-III study is a prospective, un-blinded, randomised controlled trial of Early Goal-Directed Sedation compared with Standard care. The SPICE-III study will recruit patients who are intubated and ventilated in a participating ICU, are expected to remain intubated the day after enrolment and need immediate and ongoing sedation. Due to the immediate need to choose a sedative regimen for ongoing patient safety and comfort, it is proposed that study enrolment will occur using deferred consent. A total of 100 patients from approximately 4 ICUs will be enrolled in All-SPICE. Immediately following randomisation on day 1, patients will have blood samples taken, which will be repeated on days 2, 4 and 6. These samples will be assessed for various blood-borne markers which are considered to be potentially affected by the coordination of the stress response.

Eligibility

Key inclusion criteria

Enrolled in the SPICE-III study

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

Key exclusion criteria

Nil

Contact details and further information

Primary Sponsor

Type: Government body
Name: Sunshine Coast Hospital and Health Service
Address: Nambour Hospital
Hospital Road
PO Box 547
Nambour QLD 4560
Country: Australia

Contact person for information and recruitment

Ms Lauren Murray
Sunshine Coast Institute for Critical Care Research
Department of Intensive Care
Nambour Hospital
Hospital Rd,
Nambour QLD 4560

Australia
+61 7 54706600
sciccr@health.qld.gov.au



Trial from ANZCTR

The influence of pain education on pain responses to exercise in people with chronic pain and healthy individuals

  • Recruitment status at the time of last update
    Suspended
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 10/7/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12616001141437

Date registered

22 August 2016

Health condition

Fibromyalgia, Knee osteoarthritis, Hip osteoarthritis

Recruitment countries

Australia

Recruitment site location(s) (State)

New South Wales

Recruitment status

Suspended

Anticipated date of first participant enrolment

23 August 2016

Ethics application status

Approved

Brief summary

Pain is multifactorial and involves both biological and psychological components. Multi-disciplinary treatment approaches incorporating drugs, cognitive-behavioural therapy and exercise interventions are the most efficacious for managing chronic pain. Single sessions of exercise and pain education are both demonstrated to have positive effects on pain in people with chronic pain such as fibromyalgia and osteoarthritis, however it is not known whether pain education delivered immediately prior to exercise can enhance the efficacy of exercise in relieving pain. Recent studies from our group have identified that the pain relieving effects of exercise involve a psychological component that influences the appraisal of pain; this would likely be augmented by a combination of exercise and education. The current project will examine the effect of explicit pain education about the pain relieving effect of exercise, compared to more general exercise and pain education, on pain responses to exercise in people with chronic pain (fibromyalgia and osteoarthritis) and healthy individuals. The results will provide insight into: 1) the impact of pain education on the pain response to exercise; and 2) whether this differs between healthy individuals and people with chronic pain. The outcomes may have implications for how exercise and pain education are combined in clinical practice in the management of chronic pain.

Eligibility

Key inclusion criteria

Participants in the chronic pain group must be able to speak, read and write English and have a specialist diagnosis of knee or hip osteoarthritis or fibromyalgia. Participants in the chronic pain group must also be able to refrain from analgesic medications for 24 hours.

Participants in the healthy group must be able to speak, read and write English.

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

Key exclusion criteria

For both groups: presence of a severe psychiatric, cardiovascular, pulmonary, metabolic and/or neurological disease or any other reason that it is not medically suitable for them to perform aerobic exercise.

For the chronic pain group: any other type of arthritis apart from osteoarthritis of the knee or hip or another cause of chronic pain other than osteoarthritis or fibromyalgia.

For the healthy group: currently experiencing pain, experienced musculoskeletal pain in the past 3 months, or have a history of chronic pain.

Contact details and further information

Primary Sponsor

Type: University
Name: The University of New South Wales
Address: The University of New South Wales
Sydney, NSW, 2052. Australia
Country: Australia

Contact person for information and recruitment

Mr Matthew Jones
School of Medical Sciences
The University of New South Wales
Sydney, NSW, 2052

Australia
+61 2 9385 9032
matthew.jones@unsw.edu.au



Trial from ANZCTR

An investigator initiated, multicentre, randomised double blind factorial trial to assess the effectiveness and tolerability of low-dose combination BP and cholesterol lowering therapy with placebo and standard therapy in patients with migraine.

  • Recruitment status at the time of last update
    Stopped early
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 17/7/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12616000937415

Date registered

14 July 2016

Health condition

Migraine

Recruitment countries

Australia

Recruitment site location(s) (State)

New South Wales, Queensland

Recruitment status

Stopped early

Anticipated date of first participant enrolment

01 August 2016

Ethics application status

Approved

Brief summary

Recurrent headache is a common, disabling condition affecting millions of Australians. Migraine is a major cause of burden of disease ranking up to 6th highest cause of major disability worldwide. Globally, an estimated 0.8 billion people suffer from migraine.
Headaches are a leading cause of lost work productivity, with reduced performance rather than absence from work being the main cause of lost productive time.
There would therefore be considerable value in a simple, highly tolerable preventive therapy for the large number of people suffering from frequent migraine. In the pilot phase of this trial, the key objectives are to determine the recruitment, adherence, BP and LDL differences and assess the safety of the inventions consisting of a low-dose BP lowering combination and/or a low-dose statin in participants who experience frequent migraine.

Eligibility

Key inclusion criteria

Migraine headache (with or without typical aura) according to the diagnostic criteria of the International Headache Society (IHS)
* 2-14 days per month with migraine headache averaged over past 3 months (90-days), as self-reported by subject
* Migraine symptoms must have been present for greater than or equal to 1 year prior to enrolment in the study.
* Onset of migraine symptoms must have occurred before the age of 50 years
* Adults between 18 and 65 years
* Office SBP greater than or equal to 130mmHg and DBP greater than or equal 80 mmHg
* No definite contraindications to any of the study medications at the doses used in this trial. (Subjects can be taking other preventive and therapeutic medications as long as they do not contraindicate study medication. Patients will not be eligible if they are taking medications from the same class as the study treatments)
* Is medically stable as determined by the Study Investigator
* If taking any concomitant migraine preventative medication(s), is on a stabilised dosage at the discretion of the Investigator
* Is willing to stay on current migraine preventative medication(s) for the duration of the study
* Is able to take oral medication, adhere to the medication regimens, and perform study procedures over the study duration.

Minimum age

18 Years

Maximum age

65 Years

Gender

Both males and females

Key exclusion criteria

* Contraindication to any of telmisartan, amlodipine, indapamide, rosuvastatin, ezetimibe, simvastatin or propranolol
* Concomitantly taking an angiotensin receptor blocker, angiotensin converting enzyme inhibitor, calcium channel blocker, diuretic or statin.
* Definite indication to any one or more of the study medications
* Subject has history of cluster headaches
* Subject who exclusively has migraine aura without headache, migraine with brainstem aura, hemiplegic migraine or chronic migraine
* Medication overuse headaches according to International Headache Society criteria
* Female patients who are pregnant, nursing, or those not using adequate birth control, if capable of bearing children.
* Chronic medical illnesses (e.g. lupus) that could potentially affect frequency of headache as determined by the Study Investigator
* Alcohol or substance abuse within the last year
* Any concurrent medical or psychiatric condition which, in the investigator's judgment, may interfere with study conduct or which contraindicates participation
* Abnormal creatinine, urea or electrolytes on screening.
* Inability to provide informed consent.
* Participation in a concurrent interventional medical investigation or clinical trial. Subjects in observational, natural history and/or epidemiological studies not involving an intervention are eligible.

Contact details and further information

Primary Sponsor

Type: Other
Name: The George Institute for Global Health
Address: Level 10, King George V Building
Missenden Road
Camperdown, NSW 2050
Country: Australia

Contact person for information and recruitment

Ms Ruth Freed
The George Institute for Global Health, Australia
Level 10, King George V Building, 83-117 Missenden Rd, Camperdown NSW 2050
Australia
+61 2 8052 4522
rfreed@georgeinstitute.org.au



Trial from ANZCTR

Mitochondrial agents in the treatment of chronic fatigue syndrome: a 20-week, open-label, intervention trial

  • Recruitment status at the time of last update
    Stopped early
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 10/1/2017)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12616000567426

Date registered

03 May 2016

Health condition

Chronic Fatigue Syndrome

Recruitment countries

Australia

Recruitment site location(s) (State)

Victoria

Recruitment status

Stopped early

Anticipated date of first participant enrolment

03 May 2016

Ethics application status

Approved

Brief summary

Chronic fatigue syndrome (CFS) is a prolonged multisystem illness, characterised by very poor stamina, delayed post-exertional fatigue, which adversely affects one’s functioning across numerous physical and mental domains. Current treatments for CFS include pharmacological (e.g. fluoxetine, rintatolimod, galantamine), psychological (e.g. cognitive behaviour therapy (CBT), adaptive pacing therapy), and lifestyle interventions. For many who remain in treatment, they continue to experience significant social, occupational, and functional impairment. Thus new treatment approaches are urgently needed.
While significant fatigue remains a common complaint across numerous disorders, it is posited that CFS is related to metabolic dysfunction, mitochondrial dysfunction and impaired biogenesis, in turn related to oxidative stress and systemic inflammation. Mitochondria are structures within cells primarily responsible for energy generation, and are particularly active in oxygen-rich and highly energy dependent tissues, such as the brain. Recent research suggests that patients suffering from CFS may improve with the supplementation of mitochondrial nutrients and antioxidants. This supplementation may be associated with the reduction to mitochondrial membranes, restoring mitochondrial energy production, protecting cellular structures and enzymes from oxidative damage, and decreasing fatigue. Given that CFS is largely a heterogeneous illness associated with a complex and multifactorial aetiology, combined with the present state of available treatments, it is plausible that the introduction of a combination of metabolic therapies may have positive effects on mitochondrial dysfunction and lead to symptom improvement for CFS sufferers.

Eligibility

Key inclusion criteria

a. Male and female patients aged 18 to 65 years,
b. Diagnosed with chronic fatigue syndrome by an independent physician (a letter or referral will be preferred to confirm diagnosis),
c. Fulfil criteria for CFS as per the US Centres for Disease Control and Prevention (CDC), which requires persistent, unexplained fatigue for at least 6 months, concurrent with at least four of the following, 1) Impaired memory/concentration, 2) Sore throat, new headaches, 3) Unfreshreshing sleep, muscle pain, 4) Multi-joint pain 5)Tender lymph nodes
6) Post-exertional malaise
d. Have capacity to consent to the study and comply with study procedures,
e. Be using effective contraception if female, sexually active and of childbearing age,
f. Participants currently under any form of therapy will need to have been on that therapy for at least four (4) weeks prior to enrolment.

Minimum age

18 Years

Maximum age

65 Years

Gender

Both males and females

Key exclusion criteria

a. Patients with known or suspected active and unstable systemic medical disorder,
b. Patients who have a major depressive episode in the two years preceding the diagnosis of CFS,
c. Acute suicidality as indicated by a score of 5 or 6 on Item 10 of the MADRS (or at the discretion of Principal Investigator)
d. Patients with current diagnosis of a psychotic disorder, bipolar disorder, substance abuse/dependence, eating disorder, significant personality disorder,
e. Recent gastrointestinal ulcers or renal stones,
f. Individuals who are pregnant or lactating,
g. Individuals with a diagnosis of epilepsy,
h. Those who are currently taking any of the study preparations (a 2-week washout period will be required if participants currently taking the study preparations would like to take part) or over 200micrograms of selenium/day,
i. Individuals currently enrolled in any other intervention study,
j. Individuals needing warfarin or phenytoin,
k. Individuals who are intolerant to or have had an anaphylactic reaction to any components of the preparation,
l. Inability to comply with either the requirements of informed consent or the treatment protocol.

Contact details and further information

Primary Sponsor

Type: University
Name: The University of Melbourne
Address: Grattan st
Parkville 3052 VIC
Country: Australia

Contact person for information and recruitment

Dr Jenifer Murphy
The Melbourne Clinic Professorial Unit & The University of Melbourne
2 Salisbury St
Richmond
VIC 3121
Australia
+61394874748
jenifer.murphy@unimelb.edu.au



Trial from ANZCTR

Double-blinded placebo-controlled study of modafinil to relieve the post-exertional exacerbation of fatigue in patients with chronic fatigue syndrome undertaking exercise.

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 21/9/2017)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12616000487415

Date registered

13 April 2016

Health condition

chronic fatigue syndrome

Recruitment countries

Australia

Recruitment site location(s) (State)

New South Wales

Recruitment status

Recruiting

Anticipated date of first participant enrolment

18 April 2016

Ethics application status

Approved

Brief summary

A post-exertional exacerbation of fatigue and other symptoms is a characteristic feature of chronic fatigue syndrome (CFS) following a relatively small amount of physical or cognitive activity. Although it is well established that graded exercise therapy (GET) is beneficial for the management of CFS, this intervention, which uses cautious, symptom-limited increases in gentle aerobic exercise, has only modest effectiveness. The key limiting factor is the delayed exacerbation of symptoms that follows exercise. This post-exertional exacerbation has been well characterized in exercise challenge studies.

Modafinil, a psycho-stimulant drug, has been licensed in Australia and internationally and used clinically for some time. Additionally, it has demonstrated some benefit in reducing fatigue in multiple sclerosis, and daytime sleepiness in Parkinson’s disease. In healthy subjects, the effect of a single dose of modafinil on exercise time has been examined and showed a prolonged time to exhaustion of 22% for high intensity exercise (Jacobs and Bell, 2004). Interestingly, the rate of perceived exertion (RPE) reported by participants was statistically significantly lower in the modafinil exercise trial compared to the placebo exercise trial.

Since the symptom of fatigue is the limiting factor in the progression of GET, it is appealing to test the possibility that modafinil may attenuate the exacerbation of fatigue following exercise for patients with CFS. This opens up the possibility of greater progression in GET and, therefore, potentially further increases in physical function. However, before a training study is undertaken a systematic evaluation of the acute response of the post-exertional exacerbation of fatigue and symptoms following modafinil is warranted.

It is hypothesized that for modafinil compared to placebo, patients will report a lower RPE during exercise and less post-exertional exacerbation of fatigue. The protocol will involve two sessions of a six-day assessment period, each including a 48 hour pre-exercise baseline assessment and 96 hour post-exercise assessment. Each participant (n=20) will be asked to complete two exercise sessions (one with modafinil and one with placebo) separated by at least two weeks. The order of the treatment trial (placebo or modafinil) will be randomised and counter-balanced as well as double-blinded. The exercise bout will consist of moderate-intensity cycling for generally 20 minutes.

Eligibility

Key inclusion criteria

i) meeting international diagnostic criteria for chronic fatigue syndrome (Fukuda, 1994)
ii) have their treating exercise physiologist and clinical psychologist resolve that they have a stable pattern of symptom severity, as well as having optimized and stable sleep patterns and well-managed mood disturbance
iii) undertaking regular of 10-20 minutes walking at a gentle pace without producing a post-exertional exacerbation of symptoms (that is an hour or more of worsened fatigue and other symptoms).

Minimum age

18 Years

Maximum age

60 Years

Gender

Both males and females

Key exclusion criteria

i) currently use beta-blockers or other agents known to affect heart rate response to exercise; or
ii) have any medical (e.g. lower limb injury) condition which may preclude reliable participation in exercise testing
iii) currently use central nervous system medications (e.g. Benzodiazepines and other sedative-hyponotics (e.g. stilnox), anti-epileptics, high-dose antidepressants (low-dose allowed),
iv) are pregnant or breastfeeding
v) have hepatic impairment
vi) are hypersensitive to modafinil
vii) have a history of left ventricular hypertrophy or ischaemic heart disease, or other clinically significant cardiac disease;
viii) uncontrolled anxiety disorder,
ix) have previously taken modafinil and experienced an adverse reaction.
x) taking anti-hypertensives/beta blockers
xi) taking corticosteroids
xii) taking major analgesics (e.g. oxycodone)

Contact details and further information

Primary Sponsor

Type: University
Name: University of New South Wales
Address: University of New South Wales, Sydney, NSW 2052 Australia
Country: Australia

Contact person for information and recruitment

Dr Matthew Jones
School of Medical Sciences
UNSW Medicine
Wallace Wurth Building, High Street
UNSW AUSTRALIA NSW 2052
Australia
+61293858272
matthew.jones@unsw.edu.au



Trial from ANZCTR

A randomised controlled trial of online continuing education for health professionals to improve the management of CFS.

  • Recruitment status at the time of last update
    Completed
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 16/10/2017)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12616000296437

Date registered

07 March 2016

Health condition

Chronic Fatigue Syndrome, Myalgic encephalomyelitis

Recruitment countries

Australia

Recruitment site location(s) (State)

Australian Capital Territory, New South Wales, Northern Territory, Queensland, South Australia, Tasmania, Western Australia, Victoria

Recruitment status

Completed

Anticipated date of first participant enrolment

16 September 2016

Ethics application status

Approved

Brief summary

Chronic fatigue syndrome (CFS) is a serious and debilitating illness that affects between 0.2-2.6% of the world’s population (Prins et al, 2006). There is Level One evidence indicating that graded exercise therapy (GET) and cognitive behavioural therapy (CBT) is currently the most effective means to manage CFS (for review see Larun et al, 2015; Prince et al, 2008). Despite GET and CBT being widely acknowledged as best-practice interventions for CFS, the great majority of patients in Australia are not receiving these appropriate evidence-based interventions. Recent studies have demonstrated that the reason for this documented gap between research and practice is largely due to practicing health professionals lacking the knowledge and skills to provide appropriate care.
In order to address this lack of knowledge, our group has developed a CFS Treatment Manual and accompanying DVD aimed at providing clinicians with the knowledge and skills required to effectively manage CFS. However, recent studies have documented that seeking to train clinicians simply by providing a manual is ineffective (Wiborg et al, 2014). Other barriers to continuing education of practicing clinicians include the financial expense of courses and the geographical constraints of attending training (McHugh & Barlow, 2010). The proposed study aims to conduct a randomised controlled trial (RCT) to evaluate the efficacy of the eLearning activity in improving clinician knowledge of CFS and their confidence and skills in implementing evidence-based CFS interventions.

Eligibility

Key inclusion criteria

Fully registered member of relevant allied health professional body (e.g., Australian Psychological Society, Exercise and Sports Science Association), currently practicing.

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

Key exclusion criteria

Studying to be a health professional but without having completed the relevant degree.

Contact details and further information

Primary Sponsor

Type: University
Name: University of New South Wales
Address: UNSW Australia
High St
Kensington, NSW 2052
Australia
Country: Australia

Contact person for information and recruitment

Dr Sophie Huk Lahn Li
UNSW Australia
High Street
Kensington, NSW, 2052
Australia
+61 (2) 9385 8709
s.h.li@unsw.edu.au



Trial from ANZCTR

A pilot study exploring pacing to increase physical activity: Is active video gaming a feasible and acceptable strategy for adults with Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome (ME/CFS)?

  • Recruitment status at the time of last update
    Active, not recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 6/2/2018)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12616000285459

Date registered

04 March 2016

Health condition

chronic fatigue syndrome, myalgic encephalomyelitis

Recruitment countries

Australia

Recruitment site location(s) (State)

South Australia

Recruitment status

Active, not recruiting

Anticipated date of first participant enrolment

19 December 2016

Ethics application status

Approved

Brief summary

There is much confusion in the community regarding the difference between using a Graded Exercise Therapy (GET) protocol to increase activity and a pacing protocol to increase activity. This project is using a pacing protocol to increase activity – a concept not well investigated in the literature.
Aims
1. To determine the feasibility and acceptability of pacing plus active video gaming as a management strategy to increase physical activity levels in adults with CFS/ME
2. To explore if pacing plus active video gaming is an effective management strategy to increase physical activity for people with ME/CFS
3 To explore whether pacing plus conventional physical activity differs in effectiveness to pacing plus active video gaming compared to pacing alone
4. To explore the relationship between allostatic load and physical activity in people with CFS/ME



Eligibility

Key inclusion criteria

1. GP clearance will be required by all participants.
2. participants are required to self-report diagnosis of ME/CFS by a general practitioner or medical specialist and be based on one of the commonly accepted criteria (the Oxford Criteria is not acceptable)able to complete exercise test (either maximal or submaximal)
3. not currently playing active video games
4. low to moderate on Sports Medicine Australia Exercise Screening Tool
5. self-report less than 150 minutes of moderate intensity activity each week (not meeting National Physical Activity Guidelines)

Minimum age

18 Years

Maximum age

65 Years

Gender

Both males and females

Key exclusion criteria

1. self-reported aggravation of symptoms with 5 or less minutes of screen-time
2. self-reported aggravation of symptoms with 5 or less minutes of light intensity physical activity or movement
3. using active video games
4. not diagnosed with ME/CFS

Contact details and further information

Primary Sponsor

Type: Individual
Name: Dr Katia Ferrar
Address: University of South Australia
City East Campus, Cnr North Terrace and Frome Road
GPO Box 2471, Adelaide SA, 5001
Country: Australia

Contact person for information and recruitment

Dr Katia Ferrar
University of South Australia
GPO Box 2471
Adelaide, South Australia 5001
Australia
+61883022554
katia.ferrar@mymail.unisa.edu.au



Trial from ANZCTR

Clinical protocol for a Phase 1, randomized, double-blind, placebo-controlled, sequential-panel, ascending single-dose study to evaluate the safety, tolerability, and pharmacokinetics of CMX-020 in healthy male and female subjects.

  • Recruitment status at the time of last update
    Withdrawn
  • What is the status of the ethics application?
    Ethics status: Submitted, not yet approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
    (provisional)
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 27/6/2016)
  • Ethics status: Submitted, not yet approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12615001255572p

Date registered

17 November 2015

Health condition

The study will be conducted in healthy male and female subjects. CMX-020 is indicated for the treatment of chronic pain.

Recruitment countries

Australia

Recruitment site location(s) (State)

South Australia

Recruitment status

Withdrawn

Anticipated date of first participant enrolment

23 November 2015

Ethics application status

Submitted, not yet approved

Brief summary

This is a Phase I, Randomized, Double-Blind, Placebo-Controlled, Sequential-Panel, Ascending Single-Dose Study To Evaluate the Safety, Tolerability, and Pharmacokinetics of CMX-020 In Healthy Male and Female Subjects.

Eligibility

Key inclusion criteria

- The subject is a healthy adult male or adult female between the ages of 18-50 years, inclusive.
- The subject must weigh at least 50 kg and no more than 90 kg and have a body mass index (BMI) between 18 and 32 kg/m2, inclusive
- The subject must be in good health as determined by a physician. If female, must have a negative urine pregnancy test result at the Screening Visit, and be non-lactating

Minimum age

18 Years

Maximum age

50 Years

Gender

Both males and females

Key exclusion criteria

- The subject has a history of drug abuse or a history of alcohol abuse within the past 2 years
- The subject has systolic blood pressure > 140 mm Hg or < 85 mm Hg, or diastolic blood pressure > 90 mm Hg or < 60 mm Hg during the Pretreatment Screening or Baseline/Check-in Periods
- The subject has a pulse > 100 beats/minute or < 55 beats/minute during the Pretreatment Screening or Baseline/Check-in Periods
- The subject has active liver disease, jaundice, or an alanine transaminase (ALT) level or aspartate transaminase (AST) level of greater than 1.5 times the upper limit of normal (ULN) during the Pretreatment Screening or Baseline/Check-in Periods

Contact details and further information

Primary Sponsor

Type: Commercial sector/Industry
Name: Cytometix Australia Pty Ltd
Address: c/o Cytometix Inc
9445 Fairway Circle
Bayside, WI 53217 USA
Country: United States of America

Contact person for information and recruitment

Mrs Peggy Tom
Cytometix Australia Pty Ltd
c/o Cytometix Inc
9445 Fairway Circle
Bayside, WI 53217 USA
United States of America
+1 (414) 745-8000
peggy@cmxtwenty.com



Trial from ANZCTR

The effects of acute pain on emotional regulatory skill for chronic-pain patients in comparison to controls matched by age and gender.

  • Recruitment status at the time of last update
    Not yet recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Not up to date
    (Last updated: 3/7/2015)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Not up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12615000692538

Date registered

03 July 2015

Health condition

Chronic Pain

Recruitment countries

New Zealand

Recruitment status

Not yet recruiting

Anticipated date of first participant enrolment

13 July 2015

Ethics application status

Approved

Brief summary

When people experience pain, attention is continually sequestered by pain, or the expectation of pain. This attentional priority places a demand on cognitive resources and impairs people’s performance at cognitively demanding tasks, including regulating the strong negative emotions often associated with pain. The long-term demands that chronic pain places on attention can eventually deplete self-regulatory resources and increase pain-related cognitive impairment. It is yet unclear if such an effect holds for emotional-regulatory ability. Given the cognitive demands of pain, it is expected that emotional-regulatory ability will be impaired to varying degrees by both acute and chronic physical discomfort, similar to that occurring in pain.
To determine this, chronic pain patients and age/gender matched controls will be compared on measures of personality characteristics, and their ability to regulate their emotional expressions before and after a task designed to evoke sensations similar to pain. This matched control group will help determine if any effects on emotional-regulatory ability associated with the pain-like task are unique to chronic pain or due to the effects of the pain-like task in general.

Eligibility

Key inclusion criteria

Inclusion criteria for the chronic pain sample are: that the participant has had pain for at least six months; and be fluent in English so they can complete the English-language validated questionnaire measures. Inclusion criteria for the matched, pain-free sample are the same as the chronic pain sample, with the exception of not experiencing more than seven consecutive days of pain within the last month.

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

Key exclusion criteria

Exclusion criteria identify those participant characteristics that might lead to adverse effects from the weight-lifting task or confound interpretation of the study findings. These criteria apply equally to both the chronic-pain and matched control samples. Exclusion criteria include: physical comorbidities that might hinder participation, such as facial nerve pathology that prevents emotional expression and mobility issues that have not been adequately addressed in the study design; psychological comorbidities that expert clinicians judge as possibly leading to adverse pain experiences, emotional distress or that confound interpretation of findings (e.g. psychosis, disorders of thought or disorders of motivation); and clinically identified severe health complications (e.g. cancers) from which study participation may cause needless distress and that would also could confound interpretation of findings.

Contact details and further information

Primary Sponsor

Type: University
Name: Department of Health Psychology, University of Auckland
Address: Level 12
Auckland City Hospital Support Building
Park Road
Grafton
Auckland 1023
Country: New Zealand

Contact person for information and recruitment

Mr Duncan Edwards
Room 599 12.004
Department of Psychological Medicine,
Faculty of Medicine and Health Sciences,
University of Auckland
Level 12
Auckland City Hospital Support Building,
Park Road
Grafton
Auckland 1023
New Zealand
+64 9 923 7284
dedw122@uoa.auckland.ac.nz