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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02122393




Registration number
NCT02122393
Ethics application status
Date submitted
22/04/2014
Date registered
24/04/2014
Date last updated
29/04/2014

Titles & IDs
Public title
A Randomised Trial of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
Scientific title
A Randomised, Controlled Evaluation of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
Secondary ID [1] 0 0
H2001/01263
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Anxiety 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression
Reproductive Health and Childbirth 0 0 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sertraline
Behaviour - Cognitive Behavioural Therapy

Active Comparator: Sertraline -

Active Comparator: Cognitive Behavioural Therapy -

Active Comparator: Combined Therapy -


Treatment: Drugs: Sertraline


Behaviour: Cognitive Behavioural Therapy
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Beck Depression Inventory
Timepoint [1] 0 0
24 weeks
Secondary outcome [1] 0 0
Beck Anxiety Inventory
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
Parenting Stress Index
Timepoint [2] 0 0
24 weeks

Eligibility
Key inclusion criteria
- Women with an infant > 2 months and < 8 months of age

- Infant born after a full-term pregnancy

- Infant born with no congenital abnormalities

- Diagnosis of depression with postnatal onset according to the Diagnostic and
Statistical Manual of Mental Disorders 4th Edition (DSM-IV).
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- positive serum pregnancy test;

- concurrent psychiatric disorder (excepting co-morbid anxiety);

- recent history of antidepressant usage (within the last month);

- history of major allergy or drug allergy;

- history of substance abuse;

- prior non-response to sertraline, or prior non-response to adequate trials of two
selective serotonin reuptake inhibitors (SSRIs);

- predisposition to headache, migraine or nausea;

- tobacco habit in excess of 10 cigarettes per day;

- caffeine consumption in excess of 6 cups of coffee/tea or cola-flavoured drinks per
day;

- ongoing dental work;

- extreme levels of depression (psychotic);

- suicidal intent;

- participation in any medical trial within the previous three months;

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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2002
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2005
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Health - Melbourne
Recruitment postcode(s) [1] 0 0
3081 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Th purpose of this study is to determine whether dual psychological and pharmacological
treatment is superior to either mono-therapy alone in the treatment of postnatal depression.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02122393
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jeannette Milgrom, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02122393