A Randomised Trial of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal Depression
NCT ID: NCT02122393
Last Updated: 2014-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
45 participants
INTERVENTIONAL
2002-04-30
2005-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prophylactic Use of Postpartum Sertraline to Prevent Postpartum Depression
NCT02235064
Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression
NCT00602355
Sertraline for the Prevention of Recurrent Postpartum Depression
NCT00276900
Postpartum Depression: Transdermal Estradiol Versus Sertraline
NCT00744328
Effects and Consequences for Mother and Child From Treatment for Depression
NCT02185547
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sertraline
Sertraline
Cognitive Behavioural Therapy
Cognitive Behavioural Therapy
Combined Therapy
Sertraline
Cognitive Behavioural Therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sertraline
Cognitive Behavioural Therapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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;
18 Years
40 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
University of Melbourne
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jeannette Milgrom
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeannette Milgrom, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Melbourne
Alan W Gemmill, PhD
Role: STUDY_DIRECTOR
Austin Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Austin Health
Melbourne, Victoria, Australia
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H2001/01263
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.