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

NCT00602355 | Completed Phase 2 Results DMC

• 3 other identifiers: R01MH074919R01MH074636DSIR 83-ATP
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Depression, Postpartum

Keywords

Postpartum; Depression; Medication Therapy; Zoloft; Sertraline; Interpersonal Psychotherapy

Outcome Measures

Primary Outcomes (1)

• Hamilton Depression Rating Scale (HAM-D)

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

  Measured at baseline; post-treatment; and Months 3 and 6 of follow-up

Secondary Outcomes (4)

• Depression Illness Severity Based on Beck Depression Inventory (BDI)

  Measured at baseline; post-treatment; and Months 3 and 6 of follow-up

• Global Illness Severity Based on Clinical Global Impression (CGI) Scale

  Measured at baseline; post-treatment; and Months 3 and 6 of follow-up

• Social Functioning Based on Postpartum Adjustment Questionnaire (PPAQ)

  Measured at baseline; post-treatment; and Months 3 and 6 of follow-up

• Hamilton Anxiety Rating Scale (HARS)

  Measured at baseline; post-treatment; and Months 3 and 6 of follow-up

Study Arms (3)

1 (Placebo)

PLACEBO COMPARATOR

Participants receiving placebo pill with clinical management plus mothercrafting

Drug: Placebo; Behavioral: Clinical management; Behavioral: Mothercrafting

2 (Sertraline)

ACTIVE COMPARATOR

Participants receiving active medication sertraline with clinical management plus mothercrafting

Drug: Sertraline; Behavioral: Clinical management; Behavioral: Mothercrafting

3 (IPT)

ACTIVE COMPARATOR

Participants receiving interpersonal psychotherapy (IPT) alone

Behavioral: Interpersonal psychotherapy (IPT)

Interventions

Sertraline DRUG

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.

Also known as: Zoloft

2 (Sertraline)

Placebo DRUG

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.

1 (Placebo)

Interpersonal psychotherapy (IPT) BEHAVIORAL

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.

3 (IPT)

Clinical management BEHAVIORAL

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

1 (Placebo); 2 (Sertraline)

Mothercrafting BEHAVIORAL

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

1 (Placebo); 2 (Sertraline)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

• 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.

  PMID: 30447565 DERIVED

MeSH Terms

Conditions

Depression, Postpartum; Depression

Interventions

Sertraline; Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Caron Zlotnick
• Organization: Women and Infants Hospital

czlotnick@butler.org

401-455-6529

Study Officials

• Caron Zlotnick

  Women and Infants Hospital

  PRINCIPAL INVESTIGATOR

• Scott Stuart, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Behavioral Medicine Research

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: January 28, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 21, 2016
• Results First Posted: September 21, 2016

Record last verified: 2016-07

Locations

US (2)