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

• ClinicalTrials.gov Identifier: NCT00602355
• Recruitment Status: Completed
• First Posted: January 28, 2008
• Results First Posted: September 21, 2016
• Last Update Posted: September 21, 2016
• Sponsor: Women and Infants Hospital of Rhode Island
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Caron Zlotnick, Women and Infants Hospital of Rhode Island

Tracking Information

• First Submitted Date: January 23, 2008
• First Posted Date: January 28, 2008
• Results First Submitted Date: June 1, 2016
• Results First Posted Date: September 21, 2016
• Last Update Posted Date: September 21, 2016
• Study Start Date: February 2008
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 29, 2016)

Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up ]

Measure total ranges from 0 to 50, with lower scores indicating better outcomes.

• Original Primary Outcome Measures (submitted: January 23, 2008): 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 ]

Current Secondary Outcome Measures (submitted: July 29, 2016)

• Depression Illness Severity Based on Beck Depression Inventory (BDI) [ Time Frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up ]
  Measure total ranges from 0 to 56, with lower scores indicating better outcomes.
• Global Illness Severity Based on Clinical Global Impression (CGI) Scale [ Time Frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up ]
  Measure total ranges from 1 to 7, with lower scores indicating better outcomes.
• Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ) [ Time Frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up ]
  Measure total ranges from 1 to 5, with lower scores indicating better outcomes.
• Hamilton Anxiety Rating Scale (HARS) [ Time Frame: Measured at baseline; post-treatment; and Months 3 and 6 of follow-up ]
  Measure total ranges from 0 to 56, with lower scores indicating better outcomes.

Original Secondary Outcome Measures (submitted: January 23, 2008)

• 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 ]
• 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 ]
• 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 ]
• 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 ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness of Sertraline Alone and Interpersonal Psychotherapy Alone in Treating Women With Postpartum Depression
• Official Title: Placebo Controlled Trial of Sertraline and Interpersonal Psycho-Therapy for Postpartum Depression
• Brief Summary: This study will evaluate the effectiveness of antidepressant medication alone and interpersonal psychotherapy alone in treating women with postpartum depression.

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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Depression, Postpartum

Intervention

• 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
• 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: 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.
• 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

Study Arms

• Placebo Comparator: 1 (Placebo)
  Participants receiving placebo pill with clinical management plus mothercrafting
  Interventions:

  • Drug: Placebo
  • Behavioral: Clinical management
  • Behavioral: Mothercrafting
• Active Comparator: 2 (Sertraline)
  Participants receiving active medication sertraline with clinical management plus mothercrafting
  Interventions:

  • Drug: Sertraline
  • Behavioral: Clinical management
  • Behavioral: Mothercrafting
• Active Comparator: 3 (IPT)
  Participants receiving interpersonal psychotherapy (IPT) alone
  Intervention: Behavioral: Interpersonal psychotherapy (IPT)

• Publications *: O'Hara MW, Pearlstein T, Stuart S, Long JD, Mills JA, Zlotnick C. A placebo controlled treatment trial of sertraline and interpersonal psychotherapy for postpartum depression. J Affect Disord. 2019 Feb 15;245:524-532. doi: 10.1016/j.jad.2018.10.361. Epub 2018 Oct 31.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 29, 2016): 162
• Original Estimated Enrollment (submitted: January 23, 2008): 150
• Actual Study Completion Date: July 2014
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Eligibility 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).

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00602355
• Other Study ID Numbers: R01MH074919( U.S. NIH Grant/Contract ); R01MH074919 ( U.S. NIH Grant/Contract ); R01MH074636 ( U.S. NIH Grant/Contract ); DSIR 83-ATP
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Caron Zlotnick, Women and Infants Hospital of Rhode Island
• Original Responsible Party: Caron Zlotnick, PhD, Women and Infants Hospital
• Current Study Sponsor: Women and Infants Hospital of Rhode Island
• Original Study Sponsor: National Institute of Mental Health (NIMH)
• Collaborators: National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Caron Zlotnick; Women and Infants Hospital
• Principal Investigator: Scott Stuart, MD; University of Iowa

• PRS Account: Women and Infants Hospital of Rhode Island
• Verification Date: July 2016