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Trial registered on ANZCTR


Registration number
ACTRN12615000376549
Ethics application status
Approved
Date submitted
7/04/2015
Date registered
23/04/2015
Date last updated
20/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Low Dose Atomoxetine in Cardiovascular Disease: A Pilot Study
Scientific title
Effect of low dose Atomoxetine on stress/anxiety levels and cardiovascular risk in patients with hypertension, hypercholesterolemia, diabetes or other cardiovascular disease.
Secondary ID [1] 286484 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypertension 294680 0
hypercholesterolaemia 294681 0
diabetes 294682 0
Stress/anxiety 294689 0
Overweight/obesity 294690 0
Condition category
Condition code
Cardiovascular 294984 294984 0 0
Hypertension
Mental Health 294985 294985 0 0
Anxiety
Metabolic and Endocrine 295027 295027 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral capsule of Atomoxetine Slow Release 3mg taken once daily for 8 weeks. Compliance will be monitored by drug capsule return. Followed by 6 weeks of the same schedule during which time the field will be randomised with a placebo.
Intervention code [1] 291577 0
Treatment: Drugs
Comparator / control treatment
Microcellulose capsule placebo
Control group
Placebo

Outcomes
Primary outcome [1] 294734 0
Stress/anxiety levels; Proportion of participants with a reduction in stress/anxiety; measured by Depression Anxiety Stress Scales (DASS) & Spielberger Questionnaire.
Timepoint [1] 294734 0
18 weeks
Secondary outcome [1] 313960 0
Cardiovascular risk (this is a composite secondary outcome); Proportion of participants with a reduction in weight (kg measured by scales), blood pressure (mmHg measured on an automatic sphygmomanometer), blood cholesterol (serum assay) and glucose (serum assay).
Timepoint [1] 313960 0
18 weeks

Eligibility
Key inclusion criteria
currently prescribed medication to treat hypertension, hypercholesterolaemia or diabetes; or have previously suffered an arterial clinical event such as angina, acute myocardial infarction, transient ischemic event, stroke or retinal infarct/haemorrhage; and have a body mass index of greater than 25; and elevated DASS sub scale score (stress > 4, anxiety > 4 or depression > 4)
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unstable physical illness, clinical and/or questionnaire evidence of major psychiatric disorder and/or patients currently on psychotropic medication, a DASS score > 21, patients with atrial fibrillation or blood pressure > 170/110

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 291051 0
Self funded/Unfunded
Name [1] 291051 0
Professor Simon Dimmitt
Address [1] 291051 0
Suite 3 10 McCourt St
WEST LEEDERVILLE WA 6007
Country [1] 291051 0
Australia
Primary sponsor type
Individual
Name
Professor Simon Dimmitt
Address
Dr Simon Dimmitt Pty Ltd
Suite 3 10 McCourt St
WEST LEEDERVILLE WA 6007
Country
Australia
Secondary sponsor category [1] 289735 0
None
Name [1] 289735 0
Address [1] 289735 0
Country [1] 289735 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292635 0
St John of God Health Care Human Research Ethics Committee
Ethics committee address [1] 292635 0
12 Salvado Rd
SUBIACO WA 6008
Ethics committee country [1] 292635 0
Australia
Date submitted for ethics approval [1] 292635 0
Approval date [1] 292635 0
22/10/2014
Ethics approval number [1] 292635 0
732

Summary
Brief summary
The aim of the pilot study is to establish whether low dose Atomoxetine can be clinically effective in reducing stress/anxiety, have a favourable effects on cardiovascular risk, by not increasing and possibly reducing weight, along with blood pressure, blood cholesterol and glucose.

The plan is to recruit 20 clinically stable patients for a 4 week "run-in" to establish a clear baseline, then prescribe Atomoxetine for 8 weeks. In consenting patients a further 6 weeks of double blind placebo v active will follow. All participants will be evaluated with a full history and physical examination.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 56338 0
Prof Simon Dimmitt
Address 56338 0
Dr Simon Dimmitt Pty Ltd
Suite 3 10 McCourt St
WEST LEEDERVILLE WA 6007
Country 56338 0
Australia
Phone 56338 0
+61 8 6380 9580
Fax 56338 0
Email 56338 0
sdimmitt@bigpond.com
Contact person for public queries
Name 56339 0
Mrs Alicia Moran
Address 56339 0
Dr Simon Dimmitt Pty Ltd
Suite 3 10 McCourt St
WEST LEEDERVILLE WA 6007
Country 56339 0
Australia
Phone 56339 0
+61 8 6380 9585
Fax 56339 0
Email 56339 0
alicia@achf.org.au
Contact person for scientific queries
Name 56340 0
Mrs Alicia Moran
Address 56340 0
Dr Simon Dimmitt Pty Ltd
Suite 3 10 McCourt St
WEST LEEDERVILLE WA 6007
Country 56340 0
Australia
Phone 56340 0
+61 8 6380 9585
Fax 56340 0
Email 56340 0
alicia@achf.org.au

No information has been provided regarding IPD availability
Summary results
No Results