Status:
COMPLETED
Short-Term Versus Long-Term Treatment for Severe Premenstrual Syndrome (PMS)
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Premenstrual Syndrome
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief 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...
Detailed Description
Severe PMS is a chronic and complex mood disorder that involves mood, behavioral and physical symptoms linked to the menstrual cycle with severity that disrupts functioning for as much as several week...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00318773
Start Date
February 1 2002
End Date
February 1 2008
Last Update
February 27 2009
Active Locations (1)
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1
Department of Obstetrics/Gynecology, University of Pennsylvania, School of Medicine
Philadelphia, Pennsylvania, United States, 19104