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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02122393
Recruitment Status : Completed
First Posted : April 24, 2014
Last Update Posted : April 29, 2014
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Jeannette Milgrom, 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.

Condition or disease Intervention/treatment Phase
Depression Anxiety Drug: Sertraline Behavioral: Cognitive Behavioural Therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Controlled Evaluation of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
Study Start Date : April 2002
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Beck Depression Inventory [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Beck Anxiety Inventory [ Time Frame: 24 weeks ]
  2. Parenting Stress Index [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02122393


Locations
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Australia, Victoria
Austin Health
Melbourne, Victoria, Australia, 3081
Sponsors and Collaborators
University of Melbourne
Pfizer
Investigators
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Principal Investigator: Jeannette Milgrom, PhD University of Melbourne
Study Director: Alan W Gemmill, PhD Austin Health
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Responsible Party: Jeannette Milgrom, Professor, University of Melbourne
ClinicalTrials.gov Identifier: NCT02122393    
Other Study ID Numbers: H2001/01263
First Posted: April 24, 2014    Key Record Dates
Last Update Posted: April 29, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Depression, Postpartum
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs