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

Sponsor:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00683605

Purpose

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.

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 Yale University:

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 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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 1200 mg of calcium.
2: Active Comparator Calcium	Drug: Calcium 1200 mg of calcium will be taken for 5 menstrual cycles.
3: 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 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.

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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:

Menstruating
Meet criteria for moderate to severe PMS
Report PMS symptoms for at least 9 out of the 12 months prior to screening
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: NCT00683605

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

Yale University

Investigators

Principal Investigator:

Kimberly A. Yonkers, MD

Yale University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Yale University School of Medicine ( Kimberly A. Yonkers, MD )
Study ID Numbers:	0001011511
Study First Received:	May 19, 2008
Last Updated:	May 22, 2008
ClinicalTrials.gov Identifier:	NCT00683605 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Yale University:

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 November 09, 2009