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

Phase 3

Completed

• Conditions: Anxiety; Depression
• Interventions: Drug: Sertraline; Behavioral: Cognitive Behavioural Therapy

• Registration Number: NCT02122393
• Lead Sponsor: University of Melbourne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2005-04
• Study Completion: 2005-04
• Status Verified: 2014-04
• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-22
• Study First Posted: 2014-04-24
• Last Update Submitted: 2014-04-27
• Last Update Posted: 2014-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sertraline	Sertraline	-
Cognitive Behavioural Therapy	Cognitive Behavioural Therapy	-
Combined Therapy	Cognitive Behavioural Therapy	-
Combined Therapy	Sertraline	-

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory	24 weeks

Secondary Outcome Measures

Name	Time	Method
Parenting Stress Index	24 weeks
Beck Anxiety Inventory	24 weeks

Trial Locations

Locations (1)

Austin Health; 🇦🇺 Melbourne, Victoria, Australia