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

April 27, 2014 updated by: Jeannette Milgrom, University of Melbourne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3081
        • Austin Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sertraline
Drug: Sertraline
Active Comparator: Cognitive Behavioural Therapy
Behavioral: Cognitive Behavioural Therapy
Active Comparator: Combined Therapy
Drug: Sertraline
Behavioral: Cognitive Behavioural Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Beck Depression Inventory
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Beck Anxiety Inventory
Time Frame: 24 weeks
24 weeks
Parenting Stress Index
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Melbourne

Collaborators

Pfizer

Investigators

  • Study Director: Alan W Gemmill, PhD, Austin Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 24, 2014

Study Record Updates

Last Update Posted (Estimate)

April 29, 2014

Last Update Submitted That Met QC Criteria

April 27, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2001/01263

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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