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

Sponsor:	Donaghue Medical Research Foundation
Collaborator:	Yale University
Information provided by:	Donaghue Medical Research Foundation
ClinicalTrials.gov Identifier:	NCT00965562

Purpose

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.

Condition	Intervention
Premenstrual Syndrome	Drug: Fluoxetine Drug: Calcium Drug: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Double-blind, Parallel Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)

Resource links provided by NLM:

MedlinePlus related topics: Calcium Menstruation Premenstrual Syndrome

Drug Information available for: Fluoxetine Fluoxetine hydrochloride Calcium gluconate

U.S. FDA Resources

Further study details as provided by Donaghue Medical Research Foundation:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	September 2000
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Active Comparator Fluoxetine	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 1200mg of calcium.
II: Active Comparator Calcium	Drug: Calcium 1200 mg of calcium to be taken for 5 menstrual cycles.
III: Placebo Comparator	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.

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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Eligibility

Ages Eligible for Study:	18 Years to 48 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965562

Contacts

Contact: Joanne Cunningham, Ph.D.

203-764-5719

joanne.cunningham@yale.edu

Locations

United States, Connecticut
Yale University School of Medicine	Recruiting
New Haven, Connecticut, United States, 06510

Sponsors and Collaborators

Donaghue Medical Research Foundation

Yale University

More Information

No publications provided

Responsible Party:	Yale University School of Medicine ( Kimberly A. Yonkers, MD )
Study ID Numbers:	0001011511
Study First Received:	August 24, 2009
Last Updated:	August 24, 2009
ClinicalTrials.gov Identifier:	NCT00965562 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Donaghue Medical Research Foundation:

Premenstrual syndrome
PMS
calcium

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Bone Density Conservation Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Fluoxetine

Calcium, Dietary
Serotonin Agents
Pathologic Processes
Menstruation Disturbances
Therapeutic Uses
Syndrome
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents
Premenstrual Syndrome

ClinicalTrials.gov processed this record on February 08, 2010