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

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Treatments: Sertraline

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.