Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000329561
Ethics application status
Approved
Date submitted
4/07/2006
Date registered
3/08/2006
Date last updated
22/06/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sertraline Heart Study
Scientific title
Efficacy of low dose Sertraline v's placebo in the amelioration of anxiety in heart disease.
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart disease 1298 0
Condition category
Condition code
Mental Health 1388 1388 0 0
Anxiety
Cardiovascular 1389 1389 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention 5mg Sertraline in a lactose base in an identical capsule. 1 d for 12/52 via oral route. The complete period of the trial is ~3 months.
Intervention code [1] 1188 0
Treatment: Drugs
Comparator / control treatment
Control: Lactose in an opaque capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 1892 0
Reduction in anxiety
Timepoint [1] 1892 0
Measured at 6 weeks and again at 12 weeks
Secondary outcome [1] 3345 0
Reduction in depression, reduction in fatigue, increase in effort tolerance and increase in quality of life.
Timepoint [1] 3345 0
All will be measured at 6 and 12 weeks.

Eligibility
Key inclusion criteria
Abnormal echocardiogram with history of any cardiac symptoms.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Malignancy & Psychotrophics.

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)
Allocation involved contacting the holder of the allocation schedule who was off-site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer based statistical program
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/01/2006
Actual
1/01/2006
Date of last participant enrolment
Anticipated
Actual
1/07/2007
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 6010 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 13432 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 1522 0
Charities/Societies/Foundations
Name [1] 1522 0
Mood Research Foundation (WA) Inc.
Country [1] 1522 0
Primary sponsor type
Charities/Societies/Foundations
Name
Mood Research Foundation (WA) Inc
Address
Country
Australia
Secondary sponsor category [1] 1337 0
None
Name [1] 1337 0
Nil
Address [1] 1337 0
Country [1] 1337 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2946 0
St John of God Hospital Subiaco Campus
Ethics committee address [1] 2946 0
Ethics committee country [1] 2946 0
Australia
Date submitted for ethics approval [1] 2946 0
Approval date [1] 2946 0
07/10/2004
Ethics approval number [1] 2946 0
132

Summary
Brief summary
The low dose Sertraline Heart Study is a 3 month study evaluating improvements in energy, stress and well-being with very low dose Sertraline in patients with stable heart disease. Associated benefits may include improved sleep, weight and blood pressure. Being a serotonin reuptake inhibitor, we are also interested to monitor improvements in anxiety and mood, which have never been evaluated at this very low dose before. Half of the participants will receive 'blank' or placebo capsules. There are 4 visits to the study centre over the 3 months, at which symptoms will be monitored. Blood tests are undertaken initially and at 6 weeks. Subjects, Research Assistant and Medical Director are all blinded.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36066 0
Dr Simon Dimmitt
Address 36066 0
c/o 3/10 McCourt St
WEST LEEDERVILLE WA 6007
Country 36066 0
Australia
Phone 36066 0
08 63809585
Fax 36066 0
Email 36066 0
alicia@achf.org.au
Contact person for public queries
Name 10377 0
Prof Dr Simon Dimmitt
Address 10377 0
Suite 304/25
McCourt St
Subiaco WA 6008
Country 10377 0
Australia
Phone 10377 0
+61 8 93829580
Fax 10377 0
+61 8 93829586
Email 10377 0
sdimmitt@bigpond.com
Contact person for scientific queries
Name 1305 0
Prof Dr Simon Dimmitt
Address 1305 0
Suite 304/25
McCourt St
Subiaco WA 6008
Country 1305 0
Australia
Phone 1305 0
+61 8 93829580
Fax 1305 0
+61 8 93829586
Email 1305 0
sdimmitt@bigpond.com

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
No additional documents have been identified.