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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00602355 |
This study will evaluate the effectiveness of antidepressant medication alone and interpersonal psychotherapy alone in treating women with postpartum depression.
Condition | Intervention | Phase |
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Depression, Postpartum |
Drug: Sertraline Drug: Placebo Behavioral: Interpersonal psychotherapy (IPT) Behavioral: Clinical management |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Placebo Controlled Trial of Sertraline and Interpersonal Psycho-Therapy for Postpartum Depression |
Estimated Enrollment: | 150 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | June 2012 |
Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Participants taking placebo pill plus clinical management
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Drug: Placebo
Participants taking the placebo will follow the same titration schedule as those taking sertraline.
Behavioral: Clinical management
Clinical management includes treatment as usual for those receiving medication for depression.
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2: Active Comparator
Participants receiving medication treatment alone with sertraline plus clinical management
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Drug: Sertraline
Participants assigned to sertraline treatment will take 50 to 100 mg daily for Weeks 1 through 3, and dosage will be increased to 150 to 200 mg daily in Weeks 4 through 8. However, participants who have not fully responded by Week 10 will be titrated up to 200 mg daily for the final 2 weeks of treatment.
Behavioral: Clinical management
Clinical management includes treatment as usual for those receiving medication for depression.
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3: Active Comparator
Participants receiving interpersonal psychotherapy (IPT) alone
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Behavioral: Interpersonal psychotherapy (IPT)
IPT will be administered in 12 individual 45-minute sessions over 12 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills.
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Postpartum depression (PPD) occurs in approximately 13% of postpartum women. The impact of PPD is significant, including emotional distress for the woman as well as disturbances in infant development. Common signs of depression after childbirth may include anxiety, irritability, low energy, and lack of concern for self or infant. If left untreated, PPD may last for more than 1 year, causing strain on family life and the mother's relationship with her infant. Infants of depressed mothers are also at a higher risk for developmental delays, behavioral problems, and difficulty eating and sleeping. Despite the public health significance of PPD, relatively little research has been done to determine the most effective treatments. Specifically, there is a lack of research concerning the use of antidepressant medication for treating PPD. Interpersonal psychotherapy (IPT), which focuses on interpersonal issues related to depression, has been more thoroughly studied for the treatment for PPD, but it has not been compared to the other treatment. This study will evaluate the effectiveness of antidepressant medication alone and IPT alone in treating women with PPD.
Participation in this double-blind study will last 9 months. Participants will first undergo initial assessments, which include interviews about depressive symptoms, self-report forms about medical history, blood tests, and a pregnancy test. Participants will then be randomly assigned to one of three treatments: sertraline, placebo, or IPT. All three treatments will be administered over 12 weeks. Participants assigned to take sertraline or placebo will attend eight 30-minute sessions over the 12-week treatment period. During these sessions, participants will be administered the study medication and will be assisted with parenting issues and skills by a psychiatrist. Participants receiving IPT will attend weekly 45-minute sessions over the 12-week treatment period. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills. All participants will also complete interviews and questionnaires about their depression once a month. Following the 12 weeks of treatment, participants will undergo follow-up visits occurring at Weeks 1 or 2 and Months 3 and 6 post-treatment. Follow-up assessments will repeat initial interviews and questionnaires and will include a form about the infant's nature.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Iowa | |
University of Iowa | Recruiting |
Iowa City, Iowa, United States, 52242 | |
Contact: Jennifer Bowman-Reif 319-335-0307 jennifer-bowman-reif@uiowa.edu | |
Principal Investigator: Scott Stuart, MD | |
United States, Rhode Island | |
Women and Infants Hospital | Recruiting |
Providence, Rhode Island, United States, 02905 | |
Contact: Sarah Sullivan 401-274-1122 ext 2865 sasullivan@wihri.org | |
Principal Investigator: Caron Zlotnick, PhD |
Principal Investigator: | Caron Zlotnick | Women and Infants' Hospital |
Principal Investigator: | Scott Stuart, MD | University of Iowa |
Responsible Party: | Women and Infants Hospital ( Caron Zlotnick, PhD ) |
Study ID Numbers: | R01 MH074919, R01 MH074636, DSIR 83-ATP |
Study First Received: | January 23, 2008 |
Last Updated: | September 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00602355 |
Health Authority: | United States: Federal Government |
Postpartum Depression Medication Therapy |
Zoloft Sertraline Interpersonal Psychotherapy |
Pregnancy Complications Depression Puerperal Disorders Depression, Postpartum Mental Disorders |
Mood Disorders Sertraline Depressive Disorder Serotonin Behavioral Symptoms |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Serotonin Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Psychotropic Drugs Serotonin Uptake Inhibitors Central Nervous System Agents Pharmacologic Actions Antidepressive Agents |