Short-Term Versus Long-Term Treatment for Severe Premenstrual Syndrome (PMS)

Completed · Phase 4 · Has a placebo group

Conditions studied: Premenstrual Syndrome

In brief

Serotonergic antidepressants are clearly effective for premenstrual syndrome (PMS). This study compares short-term treatment (4 months) and long-term treatment (12 months) with sertraline to determine how long medication should be continued after achieving a good response, how soon symptoms return after stopping medication, and whether symptoms are further improved with long-term treatment. Multiple hypotheses include the following: The percent of relapsed subjects is greater with short-term treatment; relapse is swifter with short-term treatment; relapsed subjects improve swiftly when returned to medication; patient satisfactions and quality of life are more improved with long-term treatment.

Key facts

Study ID

NCT00318773

Run by

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

People needed

174

Starts

2002-02-01

Expected to finish

2008-02-01

Last updated by the study team

2009-02-27

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women with PMS for at least 1 year.
• Ages 18-45 years
• Regular menstrual cycles in normal range (22-36 days) for at least 6 months
• In general good health as determined by physical examination and blood tests.
• Evidence of ovulation using a urine test.
• Meeting stated criteria for PMS.
• Signed informed consent.

You may not qualify if…

• Any prescription, over-the-counter, herbal or non-medical therapies for PMS.
• Use of psychotropic medications that cannot be stopped for the duration of the study.
• Other current psychiatric diagnoses as determined by SCID interview.
• Alcohol or substance abuse/dependence or suicide attempt within the past 12 months; lifetime history of psychosis, bipolar disorder and clearly identifiable severe personality disorder.
• Hysterectomy, symptomatic endometriosis, irregular menstrual cycles,any severe or unstable medical illness.
• Lack of medically-approved contraception, currently pregnant, intention to become pregnant or breast feeding.

Where it is running

• Department of Obstetrics/Gynecology, University of Pennsylvania, School of Medicine — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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