Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Caron Zlotnick, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier:
NCT00602355
First received: January 23, 2008
Last updated: June 30, 2014
Last verified: June 2014
  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
Behavioral: Mothercrafting
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo Controlled Trial of Sertraline and Interpersonal Psycho-Therapy for Postpartum Depression

Resource links provided by NLM:


Further study details as provided by Women and Infants Hospital of Rhode Island:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Measured at baseline; Weeks 5, 9, and 13 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 5, 9, and 13 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 5, 9, and 13 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 5, 9, and 13 of treatment; and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]
  • Hamilton Anxiety Rating Scale (HARS) [ Time Frame: Measured at baseline; Weeks 5, 9, and 13 of treatment; and Months 3 and 6 of follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Participants receiving placebo pill with clinical management plus mothercrafting
Drug: Placebo
Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific "mother-crafting" techniques as those taking sertraline.
Behavioral: Clinical management
Clinical management includes treatment as usual for those receiving medication for depression.
Behavioral: Mothercrafting
Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care
Active Comparator: 2
Participants receiving active medication sertraline with clinical management plus mothercrafting
Drug: Sertraline
Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific "mother-crafting" techniques keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.
Other Name: Zoloft
Behavioral: Clinical management
Clinical management includes treatment as usual for those receiving medication for depression.
Behavioral: Mothercrafting
Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care
Active Comparator: 3
Participants receiving interpersonal psychotherapy (IPT) alone
Behavioral: Interpersonal psychotherapy (IPT)
IPT will be administered in 13 individual 50-minute sessions over 13 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 13 weeks. Participants assigned to take sertraline or placebo will attend nine 30-minute sessions over the 13-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 50-minute sessions over the 13-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 13 weeks of treatment, participants will undergo follow-up assessments at 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 50 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 12 on HAM-D
  • Delivery of an infant within the 12 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:

  • Woman whose infant has died prior to study entry
  • Current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder;
  • Diagnosis of alcohol or drug abuse or dependence (except nicotine) or anorexia in the past year;
  • Psychotic symptoms;
  • Acute suicidal or homicidal risks;
  • Women who have been on an antidepressant for more than 14 days prior to consent, (if less than 14 days and willing to taper off, will be eligible to continue once tapered off);
  • Women on daily anxiolytic medication (i.e. benzodiazepine, buspirone) or daily psychoactive herbal preparation (St. John's Wort or Fish Oil) (if willing to discontinue these substances may be eligible once they have been tapered off);
  • Medications taken PRN over the listed dose and frequency (women will still be eligible if they take: Lunesta/Eszopiclone 3 mg or less, up to 3 nights a week, Ambien/Zolpidem 5mg or less, Ambien CR 6.25 mg or less, up to 3 nights a week, Lorazepam or equivalent benzodiazepine dose: 0.5 mg up to 3 nights a week, Sonata/Zaleplon: 5 mg or less, up to 3 nights a week, Rozerem/Ramelteon: 8 mg or less, up to 3 nights a week);
  • If they take antidepressants PRN for insomnia (eg: Desyrel/Trazodone, Elavil/Amitriptyline, Remeron/Mirtazapine;
  • Ongoing concurrent psychotherapeutic treatment or psychotherapeutic treatment within the last month;
  • Psychiatric symptoms requiring specialized psychiatric treatment;
  • Significant medical disorder that would make sertraline treatment contra-indicated,
  • Previous trial of IPT therapy with a certified IPT therapist or an adequate trial of sertraline (i.e. at least 8 weeks of at least 100 mg daily of sertraline).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602355

Locations
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Investigators
Principal Investigator: Caron Zlotnick Women and Infants Hospital
Principal Investigator: Scott Stuart, MD University of Iowa
  More Information

No publications provided

Responsible Party: Caron Zlotnick, Director of Behavioral Medicine Research, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT00602355     History of Changes
Other Study ID Numbers: R01 MH074919, R01MH074919, R01 MH074636, DSIR 83-ATP
Study First Received: January 23, 2008
Last Updated: June 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Women and Infants Hospital of Rhode Island:
Postpartum
Depression
Medication Therapy
Zoloft
Sertraline
Interpersonal Psychotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications
Sertraline
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014