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

Completed · Not applicable · Has a placebo group

Conditions studied: Premenstrual Syndrome

In brief

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.

Key facts

Study ID

NCT00965562

Run by

Donaghue Medical Research Foundation

People needed

49

Starts

2000-09-01

Expected to finish

2010-10-01

Last updated by the study team

2015-03-23

Who can join

Age: 18 and older, up to 48. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Yale School of Medicine — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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