- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00318773
Short-Term Versus Long-Term Treatment for Severe Premenstrual Syndrome (PMS)
Short-Term Versus Long-Term Treatment for Severe PMS
Study Overview
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 weeks each menstrual cycle. Estimates indicate that 20-25% of menstruating women experience severe PMS. The efficacy of serotonergic antidepressants is clearly demonstrated for severe forms of PMS in short-term treatment trials. This study compares short-term treatment (4 months) and long-term treatment (12 months) with sertraline in a randomized, placebo-controlled design. The purpose is to determine how long medication should be continued following symptom relief, to what extent and how rapidly symptoms return after stopping medication, and whether there is any additional improvement with long-term treatment.
Following a screen period for 2-3 menstrual cycles that includes a placebo-treated cycle, eligible women are randomized double-blind to the short-term or long-term treatment arm. Subjects are switched (double-blind) to placebo after 4 months or 12 months of sertraline treatment. All subjects continue the study for a total of 21 months and receive either sertraline or the matching placebo in this interval. Subjects whose symptoms return are given open-label sertraline without breaking the study blind. Subjects rate symptoms daily throughout the study using the Penn Daily Symptom Report. Other assessments are conducted at monthly intervals and include the Clinical Global Impressions Rating Scale, Sheehan Disability Scale, Hamilton Depression Rating Scale, Endicott Quality of Life Questionnaire and the Cohen Perceived Stress Scale. The overall duration of the study is expected to be 5-6 years.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Department of Obstetrics/Gynecology, University of Pennsylvania, School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Penn Daily Symptom Report (DSR)
Time Frame: daily
|
daily
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hamilton Depression Scale
Time Frame: monthly
|
monthly
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Quality of Life Questionnaire
Time Frame: monthly
|
monthly
|
Sheehan Disability Scales
Time Frame: monthly
|
monthly
|
Clinical Global Rating of Severity and Improvement
Time Frame: monthly
|
monthly
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ellen W Freeman, PhD, University of Pennsylvania, School of Medicine, Department of Ob/Gyn
- Principal Investigator: Steven J Sondheimer, MD, University of Pennsylvania
- Principal Investigator: Karl Rickels, MD, University of Pennsylvania
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease
- Menstruation Disturbances
- Syndrome
- Premenstrual Syndrome
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Sertraline
Other Study ID Numbers
- R01HD018633 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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