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Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), September 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00602355
  Purpose

This study will evaluate the effectiveness of antidepressant medication alone and interpersonal psychotherapy alone in treating women with postpartum depression.


Condition Intervention Phase
Depression, Postpartum
Drug: Sertraline
Drug: Placebo
Behavioral: Interpersonal psychotherapy (IPT)
Behavioral: Clinical management
Phase II

MedlinePlus related topics: Depression Postpartum Depression
Drug Information available for: Sertraline hydrochloride Sertraline
U.S. FDA Resources
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

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12 of treatment; and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression illness severity based on Beck Depression Inventory (BDI) and Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12 of treatment; and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
  • General illness severity based on Clinical Global Impression (CGI) scale [ Time Frame: Measured at baseline; Weeks 4, 8, and 12 of treatment; and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
  • Social functioning based on Postpartum Adjustment Questionnaire (PPAQ) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12 of treatment; and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
  • Anxiety based on Beck Anxiety Inventory (BAI) [ Time Frame: Measured at baseline; Weeks 4, 8, and 12 of treatment; and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]

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
1: Placebo Comparator
Participants taking placebo pill plus clinical management
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.
2: Active Comparator
Participants receiving medication treatment alone with sertraline plus clinical management
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.
3: Active Comparator
Participants receiving interpersonal psychotherapy (IPT) alone
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary DSM-IV diagnosis of major depressive disorder by clinical interview
  • Score of greater than 15 on HAM-D
  • Delivery of an infant within the 6 months prior to study entry
  • Able to speak and read English sufficiently to complete the study procedures
  • Willing to use effective birth control methods throughout the study

Exclusion Criteria:

  • Current or past diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder
  • Woman whose infant has died prior to study entry
  • Breastfeeding
  • Diagnosis of alcohol or drug abuse or dependence (except nicotine) in the year prior to study entry
  • Diagnosis of anorexia in the year prior to study entry
  • Acute suicidal or homicidal risks
  • Ongoing treatment with antidepressant medication, other daily psychotropic medication, or psychoactive herbal preparation (e.g., St. John's wort)
  • Ongoing concurrent psychotherapeutic treatment or psychotherapeutic treatment within the month prior to study entry
  • Psychiatric symptoms (e.g, psychotic symptoms) requiring specialized psychiatric treatment
  • Significant medical disorder that would make sertraline treatment unsafe or not recommended
  • Previous trial of IPT therapy with a certified IPT therapist or an adequate trial of sertraline (e.g., at least 100-mg daily doses of sertraline for at least 8 weeks)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602355

Locations
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            
Sponsors and Collaborators
Investigators
Principal Investigator: Caron Zlotnick Women and Infants' Hospital
Principal Investigator: Scott Stuart, MD University of Iowa
  More Information

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

Keywords provided by National Institute of Mental Health (NIMH):
Postpartum
Depression
Medication Therapy
Zoloft
Sertraline
Interpersonal Psychotherapy

Study placed in the following topic categories:
Pregnancy Complications
Depression
Puerperal Disorders
Depression, Postpartum
Mental Disorders
Mood Disorders
Sertraline
Depressive Disorder
Serotonin
Behavioral Symptoms

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 14, 2009