Status:
COMPLETED
Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
Lead Sponsor:
Donaghue Medical Research Foundation
Collaborating Sponsors:
Yale University
Conditions:
Premenstrual Syndrome
Eligibility:
FEMALE
18-48 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the efficacy of calcium carbonate to fluoxetine in the treatment of moderate to severe PMS. Second, to compare each active agent to a placebo control. Third, to...
Detailed Description
This is a double blind, randomized, placebo controlled, parallel study that will randomize 60 women at the Yale site into treatment. Participants will be screened at various collaborating ob-gyn cente...
Eligibility Criteria
Inclusion
- Female outpatients between the ages of 18 and 48 who are:
- Menstruating
- Meet criteria for moderate to severe PMS
- Report PMS symptoms for at least 9 our of the 12 months prior to screening; 4) \*Are using an adequate method of birth control.
Exclusion
- Any candidate who:
- Fulfills MINI (DSM-IV) criteria for a serious AXIS 1 disorder
- Fulfills DSM-IV criteria during the charting phase consistent with a diagnosis of psychotic disorder, bipolar disorder or major depressive disorder
- Has a severe, co-existing condition that, in the investigator's opinion, renders the patient unsuitable for the study
- Poses a significant risk of suicide
- Takes ongoing medication that could treat PMS symptoms
- Has a history of hypersensitivity or adverse reaction to fluoxetine or calcium
- Is lactating, pregnant or is planning to become pregnant during the course of the study.
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00965562
Start Date
September 1 2000
End Date
October 1 2010
Last Update
March 23 2015
Active Locations (1)
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1
Yale School of Medicine
New Haven, Connecticut, United States, 06510