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Trial registered on ANZCTR


Registration number
ACTRN12613001135707
Ethics application status
Approved
Date submitted
4/10/2013
Date registered
11/10/2013
Date last updated
11/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does genetically guided antidepressant prescribing improve outcomes in depression?
Scientific title
Do adults with major depression whose antidepressant treatment is guided by a pharmacogenetic algorithm generated report have better clinical outcomes compared to care as usual?
Secondary ID [1] 283356 0
Nil Known
Universal Trial Number (UTN)
U1111-1148-7885
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major Depression 290253 0
Condition category
Condition code
Mental Health 290644 290644 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pharmacogenetic treatment algorithm and report to guide antidepressant dosing.
[1]
a) Patients give a buccal brush sample for DNA analysis of polymorphisms implicated in pharmacokinetic pathways
b) the algorithm provides guidance on the dosing of the antidepressant, type of antidepressant is at clinical discretion
c) any commonly used oral antidepressant currently PBS approved for treatment of major depression can be administered.
d) treatment phase of the study is 12 weeks with daily medication dosing
[2]
Compliance to medication is based on patient report to their prescriber and pharmacy collection of medication.
Intervention code [1] 288079 0
Treatment: Other
Comparator / control treatment
Care as usual - no genetically guided prescribing
Control group
Active

Outcomes
Primary outcome [1] 290659 0
Remission from major depression, a score of 7 or less on the 17-item Hamilton Depression Rating Scale
Timepoint [1] 290659 0
12 weeks
Secondary outcome [1] 304989 0
Medication Tolerability. This is assessed by patient report of side effect to their prescriber, and if the side effects is so bothersome to the patient that the prescriber reduced the dose or ceases the antidepressant this will be noted as a medication tolerability problem. Transit or persisting side effects not so bothersome to lead to dose reduction or cessation will not be considered a clinically relevant tolerability issues.
Timepoint [1] 304989 0
12wks

Eligibility
Key inclusion criteria
Principal Diagnosis Major Depression
Requires antidepressant treatment clinically
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant or Breastfeeding
Conditions where antidepressants contra-indicated
Unable to give informed valid consent

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
Active, not recruiting
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)
VIC

Funding & Sponsors
Funding source category [1] 288085 0
Self funded/Unfunded
Name [1] 288085 0
Dr Ajeet Singh
Address [1] 288085 0
PO Box 736, Drysdale, Vic 3222
Country [1] 288085 0
Australia
Primary sponsor type
Individual
Name
Dr Ajeet Singh
Address
PO Box 736, Drysdale Vic, 3222
Country
Australia
Secondary sponsor category [1] 286808 0
None
Name [1] 286808 0
Address [1] 286808 0
Country [1] 286808 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290011 0
Ethics committee address [1] 290011 0
Ethics committee country [1] 290011 0
Australia
Date submitted for ethics approval [1] 290011 0
Approval date [1] 290011 0
Ethics approval number [1] 290011 0

Summary
Brief summary
To see if a genetic test helps guide antidepressant dosing for better outcomes in depression treatment.
Trial website
Trial related presentations / publications
Data currently in analysis - no poster, oral, or publication based dissemination of the study results/methodology has been conducted.
Public notes

Contacts
Principal investigator
Name 43458 0
Dr Ajeet B Singh
Address 43458 0
PO Box 736, Drysdale Vic 3222
Melbourne University
Country 43458 0
Australia
Phone 43458 0
61352487211
Fax 43458 0
Email 43458 0
ajeetsingh@dodo.com.au
Contact person for public queries
Name 43459 0
Dr Ajeet Singh
Address 43459 0
Dr Ajeet Singh
The Geelong Clinic
PO Box 9148, St Albans Park Vic 3219
Country 43459 0
Australia
Phone 43459 0
+61352487211
Fax 43459 0
Email 43459 0
asingh@dodo.com.au
Contact person for scientific queries
Name 43460 0
Dr Ajeet Singh
Address 43460 0
Dr Ajeet Singh
The Geelong Clinic
PO Box 9148, St Albans Park Vic 3219
Country 43460 0
Australia
Phone 43460 0
+61352487211
Fax 43460 0
Email 43460 0
asingh@dodo.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary