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

PHASE4CompletedINTERVENTIONAL
Enrollment

252

Participants

Timeline

Start Date

November 6, 2007

Primary Completion Date

February 29, 2012

Study Completion Date

February 29, 2012

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.

Trial Locations (3)

10021

Cornell University, Weill Medical College, New York

23230

Virginia Commonwealth University, Richmond

06510

Yale University School of Medicine, New Haven

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Yale University

OTHER

NCT00536198 - Evaluating the Effectiveness of Sertraline in Treating Women With Premenstrual Dysphoric Disorder | Biotech Hunter | Biotech Hunter