Trial Review

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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
Sex
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
4/05/2015
Actual
14/07/2015
Date of last participant enrolment
Anticipated
Actual
19/08/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
2
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
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
[email protected]
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
[email protected]
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
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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