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

Depression, Postpartum Clinical Trial

Official title:

Placebo Controlled Trial of Sertraline and Interpersonal Psycho-Therapy for Postpartum Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00602355
• Other study ID #: R01MH074919
• Secondary ID: R01MH074919R01MH
• Status: Completed
• Phase: Phase 2
• First received: January 23, 2008
• Last updated: March 29, 2016
• Start date: February 2008
• Est. completion date: July 2014

Study information

• Verified date: March 2016
• Source: Women and Infants Hospital of Rhode Island
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder

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.
• 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.
• Clinical management
Clinical management includes treatment as usual for those receiving medication for depression.
• 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

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa
United States	Women and Infants Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Women and Infants Hospital of Rhode Island	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Rating Scale (HAM-D)		Measured at baseline; Weeks 5, 9, and 13 of treatment; and Months 3 and 6 of follow-up	No
Secondary	Depression illness severity based on Beck Depression Inventory (BDI) and Edinburgh Postnatal Depression Scale (EPDS)		Measured at baseline; Weeks 5, 9, and 13 of treatment; and Months 3 and 6 of follow-up	No
Secondary	General illness severity based on Clinical Global Impression (CGI) scale		Measured at baseline; Weeks 5, 9, and 13 of treatment; and Months 3 and 6 of follow-up	No
Secondary	Social functioning based on Postpartum Adjustment Questionnaire (PPAQ)		Measured at baseline; Weeks 5, 9, and 13 of treatment; and Months 3 and 6 of follow-up	No
Secondary	Hamilton Anxiety Rating Scale (HARS)		Measured at baseline; Weeks 5, 9, and 13 of treatment; and Months 3 and 6 of follow-up	No