A Randomised Trial of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
A Randomised, Controlled Evaluation of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
1 other identifier
interventional
45
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 depression
Started Apr 2002
Typical duration for phase_3 depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 22, 2014
CompletedFirst Posted
Study publicly available on registry
April 24, 2014
CompletedApril 29, 2014
April 1, 2014
3 years
April 22, 2014
April 27, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Beck Depression Inventory
24 weeks
Secondary Outcomes (2)
Beck Anxiety Inventory
24 weeks
Parenting Stress Index
24 weeks
Study Arms (3)
Sertraline
ACTIVE COMPARATORCognitive Behavioural Therapy
ACTIVE COMPARATORCombined Therapy
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Melbournelead
- Pfizercollaborator
Study Sites (1)
Austin Health
Melbourne, Victoria, 3081, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeannette Milgrom, PhD
University of Melbourne
- STUDY DIRECTOR
Alan W Gemmill, PhD
Austin Health
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 22, 2014
First Posted
April 24, 2014
Study Start
April 1, 2002
Primary Completion
April 1, 2005
Study Completion
April 1, 2005
Last Updated
April 29, 2014
Record last verified: 2014-04