Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
Information source: Donaghue Medical Research Foundation
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Premenstrual Syndrome
Intervention: Fluoxetine (Drug); Calcium (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Donaghue Medical Research Foundation Overall contact:
Joanne Cunningham, Ph.D., Phone: 203-764-5719, Email: joanne.cunningham@yale.edu
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 evaluate the efficacy of each treatment for specific symptom clusters
(i. e. affective and somatic). Fourth, to determine whether the addition of calcium to on
going fluoxetine treatment leads to additional therapeutic benefit.
Clinical Details
Official title: A Double-blind, Parallel Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: First, 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.
Secondary outcome: Third, to evaluate the efficacy of each treatment for specific symptom clusters (i.e. affective and somatic). Fourth, to determine whether the addition of calcium to on going fluoxetine treatment leads to additional therapeutic benefit.
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 centers for possible PMS symptoms, and direct referrals from the
community will also be accepted. Subject participation length is about 7 months with 6
scheduled study visits.
Methodology: After successfully completing the screening and qualification phase,
participants will be randomized to treatment at Visit 1 for 5 cycles of double-blind
treatment. Participants will be evaluated monthly during the randomization phase for
adverse events, concurrent medication, and primary and secondary efficacy variables.
.
Eligibility
Minimum age: 18 Years.
Maximum age: 48 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Joanne Cunningham, Ph.D., Phone: 203-764-5719, Email: joanne.cunningham@yale.edu
Yale University School of Medicine, New Haven, Connecticut 06510, United States; Recruiting
Additional Information
Starting date: September 2000
Ending date: September 2012
Last updated: August 24, 2009
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