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

NCT00965562 | Completed Results DMC

• 1 other identifier: 0001011511
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Premenstrual Syndrome

Keywords

Premenstrual syndrome; PMS; calcium

Outcome Measures

Primary Outcomes (5)

• Comparison of the Change in IDS Symptom Scores Among Groups

  IDS = Inventory of Depressive Symptomatology: measures depressive symptoms during the previous premenstrual phase with high internal consistency: sum of responses to 28 of 30 possible items each scored 0 to 3 points with total scoring (0=no symptoms, 84=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.

  over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit

• Comparison of the Change in PMTS Symptom Scores Among Groups

  PMTS = Premenstrual Tension Syndrome (Observer Rating) Scale: a clinician-administered retrospective scale developed for the study of PMS, a sum of responses to 10 items each with 4 points (0=no symptoms, 40=most severe). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.

  over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit

• Comparison of the Change in CGI-S Symptom Scores Among Groups

  CGI-S = Clinical Global Impression-Severity: a severity scale widely used in psychopharmacology research (1=normal not at all ill, 7=among most extremely ill). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.

  over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit

• Comparison of the Change in DRSP Symptom Scores Among Groups

  DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.

  over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit

• Comparison of the Change in CGI Improvement Scores Among Groups

  CGI-I = Clinical Global Impression Improvement: the improvement subscale of CGI measuring change at each visit as compared to visit 1 (1=very much improved, 7=very much worse). This outcome is a measure of effect size between the two trial groups and the placebo group, with the placebo effect size value used as a reference.

  over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit

Secondary Outcomes (6)

• Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement)

  over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit

• Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement)

  over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit

• Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement)

  over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit

• Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement)

  over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit

• Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement)

  over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit

Study Arms (3)

I

ACTIVE COMPARATOR

Fluoxetine

Drug: Fluoxetine

II

ACTIVE COMPARATOR

Calcium

Drug: Calcium

III

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Fluoxetine 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.

Also known as: Prozac

I

Calcium DRUG

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

II

Placebo 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.

III

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Donaghue Medical Research Foundation: lead
• Yale University: collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Premenstrual Syndrome

Interventions

Fluoxetine; Calcium

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Limitations and Caveats

small sample size

Results Point of Contact

• Title: Dr. Kimberly Yonkers
• Organization: Donaghue Medical Research Foundation

Kimberly.Yonkers@yale.edu

1-203-764-6621

Study Officials

• Kimberly A Yonkers, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 25, 2009
• Study Start: September 1, 2000
• Primary Completion: June 1, 2010
• Study Completion: October 1, 2010
• Last Updated: March 23, 2015
• Results First Posted: February 26, 2015

Record last verified: 2015-02

Locations

US (1)