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Trial registered on ANZCTR
Registration number
ACTRN12617000825358
Ethics application status
Approved
Date submitted
18/05/2017
Date registered
6/06/2017
Date last updated
18/07/2024
Date data sharing statement initially provided
6/05/2019
Date results provided
19/06/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
The cannabidiol youth anxiety pilot study (CAPS): a 12-week open- label pilot study of cannabidiol for anxiety disorders
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Scientific title
The cannabidiol youth anxiety pilot study (CAPS): a 12-week open- label pilot study of the safety, tolerability and efficacy of cannabidiol for anxiety disorders
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Secondary ID [1]
291931
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Nil known.
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Universal Trial Number (UTN)
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Trial acronym
CAPS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Anxiety
303295
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Condition category
Condition code
Mental Health
302723
302723
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0
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Anxiety
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Experimental intervention: All participants will receive open-label cannabidiol (CBD) for 12 weeks.
Background intervention: All participants will be offered biweekly cognitive-behaviour therapy (CBT) for 12 weeks (5 sessions). CBT will be administered as one-on-one sessions (1hr) by a qualified clinician at the study site (one of four headspace centres).
CBD will be administered on a fixed–flexible schedule beginning with 200 mg (oral capsule) per day and adjusted up to 800 mg per day by week 8. Until week 8, participants who are considered to have failed to improve using the CGI-I (operationalised as a score of >=3) and who are tolerating the medication are eligible for dose increases at each assessment. Dose escalation can occur with 200 mg/day increments, with at least a 4-week gap between dose increments, except for the first dose increase (200mg/day to 400mg/day), which can occur at the end of week 1 after tolerance of the initial dose of the study medication has been established. Participants who receive 400mg/day after week 1 are also eligible for the next dose increase at week 4. Adherence to the trial medication will be assessed by pill count.
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Intervention code [1]
298073
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Treatment: Drugs
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Intervention code [2]
298074
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Treatment: Other
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Anxiety severity after 12 weeks, measured on the Overall Anxiety Severity and Impairment Scale (OASIS). Total scores on this scale range from 0-20.
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Assessment method [1]
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Diagnosis of an anxiety disorder, as diagnosed by the Structured Clinical Interview for DSM-5.
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Assessment method [1]
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Timepoint [1]
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Week 12
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Secondary outcome [2]
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The Clinical Global Impression–Improvement (CGI-I) scale, which ranges from 1 to 7, with lower scores indicating more improvement, as compared with baseline. A score of 1 or 2 reflects a substantial, clinically meaningful improvement in anxiety severity.
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Assessment method [2]
334850
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Timepoint [2]
334850
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Week 12
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Secondary outcome [3]
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The Hamilton Anxiety Rating (HAM-A) is is one of the most used composite rating scales to measure anxiety in both clinical and research settings. It is clinician-rated and consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
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Assessment method [3]
334851
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Timepoint [3]
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Week 12
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Secondary outcome [4]
334852
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The Quick Inventory Depression Symptomatology (QIDS) assesses the criterion symptom domains for DSM-5 major depressive disorder. The scale has been shown to be a reliable tool for assessing adolescent depression, making it one of the few depression scales that has been validated across adolescent and adult populations.
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Assessment method [4]
334852
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Timepoint [4]
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Week 12
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Secondary outcome [5]
334853
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The Social and Occupational Functional Assessment Scale (SOFAS) is a widely-used global rating of current functioning, ranging from 0 to 100, with lower scores representing lower functioning.
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Assessment method [5]
334853
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Timepoint [5]
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Week 12
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Secondary outcome [6]
334854
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The Cannabis Withdrawal Scale (CWS) assess any symptoms of withdrawal as the study medication is ceased.
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Assessment method [6]
334854
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Timepoint [6]
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Weeks 13
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Secondary outcome [7]
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Adverse events (AEs), assessed with non-leading questions. Known AEs of CBD include sleepiness/mild sedation, decreased or increased appetite, diarrhea and fatigue.
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Assessment method [7]
334911
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Timepoint [7]
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Week 12
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Secondary outcome [8]
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Serious AEs (SAEs), assessed with non-leading questions. Known SAEs include convulsion.
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Assessment method [8]
335553
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Timepoint [8]
335553
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Week 12
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Eligibility
Key inclusion criteria
(1) age 12-25 inclusive;
(2) ability to give informed consent and adhere to study procedures
(parental or guardian consent will be obtained for those under the age of 18);
(3) sufficient fluency in English;
(4) diagnosis of a DSM-5 anxiety disorder (i.e., social anxiety
disorder, panic disorder, separation anxiety disorder, specific
phobia, agoraphobia, generalized anxiety disorder);
(5) failure to show substantial, clinically meaningful improvement in anxiety severity during the last 8 to 16 weeks of CBT (minimum of 5 sessions), indicated by a score of 3 or higher on the Clinical Global Impression–Improvement scale (the CGI rating
will be provided by the CBT therapist)
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Minimum age
12
Years
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Maximum age
25
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(1) DSM-5 schizophrenia spectrum disorder, delusional disorder, bipolar I disorder, substance/medication induced psychotic disorder;
(2) prior sensitivity or allergy to CBD or any cannabis-derived product;
(3) current treatment with antipsychotic medication, anxiolytic medication or mood stabiliser; or any medication that either interacts with the metabolism of CBD or is affected by CBD and in the view of the study doctor cannot be co-administered safely
(4) if prescribed antidepressive medication, the individual must have been on a stable and sufficient dose for a minimum of 6 weeks;
(5) pregnancy, lactation, or if sexually active, no effective contraception;
(6) haematological findings that result in medically significant liver, thyroid or other conditions
(7) acute or unstable systemic medical disorder;
(8) psychiatric condition due to a medical condition;
(9) acute suicidality
(10) previous or current severe drug or severe alcohol dependence;
(11) severe disturbance, such that the person is unable to comply
with either the requirements of informed consent or the treatment protocol
(6) haematological findings that result in medically significant liver, thyroid or other conditions
(9) acute suicidality
(10) previous or current severe drug or severe alcohol dependence;
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
Open-label study.
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
The main analysis will be based on all enrolled participants with at least one post-baseline observation (intention-to-treat population). The primary efficacy analysis will assess average differences for the primary outcome measure (OASIS total score) over the entire study period and will use a likelihood based mixed-effects model, repeated measures approach (MMRM).
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
16/05/2018
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Actual
25/05/2018
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Date of last participant enrolment
Anticipated
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Actual
28/06/2019
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Date of last data collection
Anticipated
31/12/2019
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Actual
24/09/2019
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Sample size
Target
30
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Accrual to date
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Final
31
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
8034
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Headspace Glenroy - Glenroy
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Recruitment postcode(s) [1]
16005
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3046 - Glenroy
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Funding & Sponsors
Funding source category [1]
296435
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Charities/Societies/Foundations
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Name [1]
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The Lambert Initiative for Cannabinoid Therapeutics
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Address [1]
296435
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The University of Sydney
Camperdown, NSW 2050
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Country [1]
296435
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Australia
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Funding source category [2]
296461
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Other
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Name [2]
296461
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Orygen, The National Centre for Excellence in Youth Mental Health
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Address [2]
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35 Poplar Road
Parkville, VIC 3052
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Country [2]
296461
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Australia
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Primary sponsor type
Other
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Name
Orygen, The National Centre for Excellence in Youth Mental Health
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Address
35 Poplar Road
Parkville, VIC 3052
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Country
Australia
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Secondary sponsor category [1]
295417
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None
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Name [1]
295417
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Address [1]
295417
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Country [1]
295417
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
297668
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Bellberry Ltd.
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Ethics committee address [1]
297668
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129 Glen Osmond Road Eastwood, SA 5063
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Ethics committee country [1]
297668
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Australia
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Date submitted for ethics approval [1]
297668
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12/05/2017
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Approval date [1]
297668
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05/09/2017
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Ethics approval number [1]
297668
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2017-02-107
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Summary
Brief summary
Affecting 15% of youth, anxiety disorders are among the most prevalent psychiatric conditions in adolescents in Australia. These disorders are associated with significant morbidity and risk of suicide attempts and predict a range of psychiatric conditions later in life. Current treatments for anxiety disorders in this age group include cognitive-behaviour therapy and/or medication. However, only 50% of young patients with anxiety disorders show satisfactory improvements with these treatments. CBD is one of several components of the plant Cannabis sativa, Unlike other substances found in this plant, CBD is devoid of psychotropic effects (i.e. alterations in thinking and perception). There is evidence from experimental studies that CBD is safe in humans and effective in reducing anxiety in healthy volunteers (e.g. in simulated public speaking tasks). A systematic review of potential side effects in humans found that CBD was well tolerated across a wide dose range, up to 1500 mg/day. However, CBD has not been tested in young people with anxiety disorders. The aim of the present study is to produce preliminary evidence for the safety and anxiolytic effects of CBD in youth with anxiety disorders. This is a single-centre, 12-week open label trial of CBD in patients aged 12-25 (inclusive) who do not respond to current treatments for anxiety disorders. All patients included into the study will receive CBD on a fixed-flexible schedule, beginning with 200mg of CBD per day, which can be adjusted up to 800mg/day for participants who tolerate CBD. The study will be conducted at a headspace centre funded through the Commonwealth Government of Australia. The headspace centre is located in the suburb of Glenroy, Orygen manages the clinical governance of this headspace site. Headspace centres focus both on youth mental health and early intervention, young people may present for care with varying illness severity (e.g. sub-threshold through to severe disorder, and mild to severely impaired functioning) across a range of mental health problems
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof G. Paul Amminger
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Address
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Orygen, 35 Poplar Road, Parkville, VIC 3052
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Country
74754
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Australia
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Phone
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+61 0399669100
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Fax
74754
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Email
74754
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paul.amminger@orygen.org.au
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Contact person for public queries
Name
74755
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Paul Amminger
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Address
74755
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Orygen, 35 Poplar Road, Parkville, VIC 3052
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Country
74755
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Australia
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Phone
74755
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+61 0399669100
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Fax
74755
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Email
74755
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paul.amminger@orygen.org.au
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Contact person for scientific queries
Name
74756
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G. Paul Amminger
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Address
74756
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Orygen, 35 Poplar Road, Parkville, VIC 3052
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Country
74756
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Australia
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Phone
74756
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+61 0399669100
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Fax
74756
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Email
74756
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paul.amminger@orygen.org.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All data, anonymised.
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When will data be available (start and end dates)?
Data are available immediately for an indefinite time.
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Available to whom?
Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data management policy.
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Available for what types of analyses?
To any type of analyses. Assessed on a case-by-case basis
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How or where can data be obtained?
Access can be requested via the Health Data Australia catalogue (https://researchdata.edu.au/health). Search for the ANZTRN number in the catalogue to find datasets associated with this trial.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Plain language summary
No
Treatment resistance is a significant problem amon...
[
More Details
]
Study results article
Yes
Berger M, Li E, Rice S, Davey CG, Ratheesh A, Adam...
[
More Details
]
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Cannabidiol for Treatment-Resistant Anxiety Disorders in Young People: An Open-Label Trial.
2022
https://dx.doi.org/10.4088/JCP.21m14130
N.B. These documents automatically identified may not have been verified by the study sponsor.
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