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

Completed · Phase 2 · Has a placebo group

Conditions studied: Depression, Postpartum

In brief

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

Key facts

Study ID

NCT00602355

Run by

Women and Infants Hospital of Rhode Island

People needed

162

Starts

2008-02-01

Expected to finish

2014-07-01

Last updated by the study team

2016-09-21

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

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).

Where it is running

• University of Iowa — Iowa City, Iowa, United States
• Women and Infants Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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