Back to resultsA Randomised Trial of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
Primary Purpose
Depression, Anxiety
Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Sertraline
Cognitive Behavioural Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Depression
Eligibility 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;
Sites / Locations
- Austin Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Sertraline
Cognitive Behavioural Therapy
Combined Therapy
Arm Description
Outcomes
Primary Outcome Measures
Beck Depression Inventory
Secondary Outcome Measures
Beck Anxiety Inventory
Parenting Stress Index
Full Information
NCT ID
NCT02122393
First Posted
April 22, 2014
Last Updated
April 27, 2014
Sponsor
University of Melbourne
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT02122393
Brief Title
A Randomised Trial of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
Official Title
A Randomised, Controlled Evaluation of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Melbourne
Collaborators
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sertraline
Arm Type
Active Comparator
Arm Title
Cognitive Behavioural Therapy
Arm Type
Active Comparator
Arm Title
Combined Therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Sertraline
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Therapy
Primary Outcome Measure Information:
Title
Beck Depression Inventory
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory
Time Frame
24 weeks
Title
Parenting Stress Index
Time Frame
24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannette Milgrom, PhD
Organizational Affiliation
University of Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan W Gemmill, PhD
Organizational Affiliation
Austin Health
Official's Role
Study Director
Facility Information:
Facility Name
Austin Health
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
A Randomised Trial of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
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