A Randomised, Controlled Evaluation of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression

University of Melbourne1 site in 1 country45 target enrollmentApril 2002

ConditionsDepression Anxiety

InterventionsSertraline Cognitive Behavioural Therapy

DrugsSertraline

Overview

Phase: Phase 3
Intervention: Sertraline
Conditions: Depression
Sponsor: University of Melbourne
Enrollment: 45
Locations: 1
Primary Endpoint: Beck Depression Inventory
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2002

End Date

April 2005

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

University of Melbourne

Responsible Party

Principal Investigator

Jeannette Milgrom

Professor

University of Melbourne

Eligibility Criteria

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).

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;