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

• Status: Completed
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Melbourne
• Collaborator: Pfizer
• Treatments: Sertraline

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;

• extreme levels of depression (psychotic);

• suicidal intent;

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