Official Title: “A Double-Blind, Parallel Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)”

The purpose of this study is 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. 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: September 2010

This is a two-center, double blind, randomized, placebo controlled, parallel study that will randomize 120 women 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. Our site's targetted enrollment is 60 subjects. 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. .

Intervention(s) in this Clinical Trial

• Drug: Fluoxetine
  • Fluoxetine 20 mg per day for 4 menstrual cycles. For the fifth menstrual cycle, all women will receive calcium. Women on Fluoxetine will continue taking it in addition to 1200 mg of calcium.
• Drug: Calcium
  • 1200 mg of calcium will be taken for 5 menstrual cycles.
• Drug: Placebo
  • For 5 cycles, women will receive placebo. At the end of the fourth cycle, all women will receive 1200 mg of calcium in addition to the placebo medication.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • I: Active Comparator Fluoxetine
• Active Comparator: 2
  • Calcium
• Placebo Comparator: 3

Primary Measures

• 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.
  • Time Frame: 6-7 Months
    Safety Issue?: No

Secondary Measures

• 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
  • Time Frame: 6-7 Months
    Safety Issue?: No

Inclusion Criteria:

• 1. Menstruating
• 2. Meet criteria for moderate to severe PMS
• 3. Report PMS symptoms for at least 9 out of the 12 months prior to screening
• 4. Are using an adequate method of birth control.

Exclusion Criteria:

Any candidate who:

• 1. Fulfills MINI (DSM-IV) criteria for a serious AXIS 1 disorder
• 2. Fulfills DSM-IV criteria during the charting phase consistent with a diagnosis of psychotic disorder, bipolar disorder or major depressive disorder
• 3. Has a severe, co-existing condition that, in the investigator's opinion, renders the patient unsuitable for the study
• 4. Poses a significant risk of suicide
• 5. Takes ongoing medication that could treat PMS symptoms
• 6. Has a history of hypersensitivity or adverse reaction to fluoxetine or calcium
• 7. Is lactating, pregnant or is planning to become pregnant during the course of the study.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 48 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Yale University

Overall Clinical Trial Officials and Contacts

Kimberly A. Yonkers, MD Principal Investigator Yale University  

Overall Contact: Joanne Cunningham, Ph.D. 203-764-5719 joanne.cunningham@yale.edu

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00683605

Study ID Number: 0001011511

ClinicalTrials.gov Identifier: NCT00683605

Health Authority: United States: Federal Government