Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Donaghue Medical Research Foundation
• Collaborator: Yale University
• Treatments: Calcium; Calcium, Dietary; Fluoxetine

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.