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OpenTrials
Completed

NCT Number: NCT02122393

A Randomised Trial 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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Austin Health

Melbourne, Victoria, 3081, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Sertraline

Drug

Cognitive Behavioural Therapy

Behavioral

Primary outcomes

  1. Beck Depression Inventory

    Time frame: 24 weeks

Secondary outcomes

  1. Beck Anxiety Inventory

    Time frame: 24 weeks

  2. Parenting Stress Index

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

University of Melbourne

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Apr 24, 2014
Registry last updated
Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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