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

NCT ID: NCT00965562

Last Updated: 2015-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2010-10-31

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 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.

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Conditions

Premenstrual Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

I

Fluoxetine

Group Type: ACTIVE_COMPARATOR

Fluoxetine

Intervention Type: DRUG

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 1200mg of calcium.

II

Calcium

Group Type: ACTIVE_COMPARATOR

Calcium

Intervention Type: DRUG

1200 mg of calcium to be taken for 5 menstrual cycles.

III

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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 1200mg of calcium.

Intervention Type: DRUG

Calcium

1200 mg of calcium to be taken for 5 menstrual cycles.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Prozac

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 48 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

Donaghue Medical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Kimberly Yonkers

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimberly A Yonkers, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

0001011511

Identifier Type: -

Identifier Source: org_study_id

NCT00683605

Identifier Type: -

Identifier Source: nct_alias