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Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder

NCT00536198 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2017-04-14

Study results available
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Summary

This study will evaluate the effectiveness of sertraline in reducing symptoms in women diagnosed with premenstrual dysphoric disorder.

Conditions

  • Premenstrual Dysphoric Disorder

Interventions

DRUG

Sertraline

50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.

DRUG

Placebo

50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Kimberly A. Yonkers, MD · Yale University

  • Margaret Altemus, MD · Weill Medical College of Cornell University

  • Susan Kornstein, MD · Virginia Commonwealth University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
48 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-06
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536198 on ClinicalTrials.gov