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

Completed · Phase 4 · Has a placebo group

Conditions studied: Premenstrual Dysphoric Disorder

In brief

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

Key facts

Study ID

NCT00536198

Run by

Yale University

People needed

252

Starts

2007-11-06

Expected to finish

2012-02-01

Last updated by the study team

2017-04-14

Who can join

Age: 18 and older, up to 48. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Menstruating and has cycles between 21 and 35 days
• Meets DSM-IV criteria for PMDD
• Experienced symptoms of PMDD in at least 9 of 12 menstrual cycles within 1 year of study entry
• Willing to use an effective form of birth control throughout the study

You may not qualify if…

• Meets MINI DSM-IV criteria for major depressive episode, substance abuse, bulimia nervosa, anorexia, bipolar disorder, or a psychotic disorder, such as schizophrenia or schizoaffective disorder, within 6 months of study entry
• Meets MINI DSM-IV criteria for a substance dependence disorder within 12 months of study entry
• Shows follicular phase symptoms consistent with a diagnosis of major depression
• Shows symptoms consistent with bipolar disorder
• Diagnosed with a severe, clinically significant co-existing condition that may prevent study participation
• Suicidal
• Taking ongoing antidepressant or other psychotropic medication
• History of hypersensitivity or an adverse reaction to sertraline
• Pregnant or breastfeeding
• Currently undergoing treatment with a depot hormonal preparation or any other medication that would lead to a lack of menses or markedly irregular menses
• Using a hormonal contraceptive pill or hormonal device within 6 months of study entry
• Taking a hormonal contraceptive pill that includes 20 micrograms of ethinyl estradiol and 3 micrograms of drospirenone
• Has been in individual psychotherapy or individual counseling for 3 months or less at study entry

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States
• Cornell University, Weill Medical College — New York, New York, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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