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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122393
• Other study ID #: H2001/01263
• Status: Completed
• Phase: Phase 3
• First received: April 22, 2014
• Last updated: April 27, 2014
• Start date: April 2002
• Est. completion date: April 2005

Study information

• Verified date: April 2014
• Source: University of Melbourne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Austin Health HREC
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depression, Postpartum
• Depressive Disorder

Intervention

Drug:
• Sertraline

Behavioral:
• Cognitive Behavioural Therapy

Locations

Country	Name	City	State
Australia	Austin Health	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
University of Melbourne	Pfizer

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory		24 weeks	No
Secondary	Beck Anxiety Inventory		24 weeks	No
Secondary	Parenting Stress Index		24 weeks	No