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

Information source: Donaghue Medical Research Foundation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Premenstrual Syndrome

Intervention: Fluoxetine (Drug); Calcium (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Donaghue Medical Research Foundation

Official(s) and/or principal investigator(s):
Kimberly A Yonkers, MD, Principal Investigator, Affiliation: Yale School of Medicine

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.

Clinical Details

Official title: A Double-blind, Parallel Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Comparison of the Change in IDS Symptom Scores Among Groups

Comparison of the Change in PMTS Symptom Scores Among Groups

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

Comparison of the Change in DRSP Symptom Scores Among Groups

Comparison of the Change in CGI Improvement Scores Among Groups

Secondary outcome:

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

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

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

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

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

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

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. .

Eligibility

Minimum age: 18 Years. Maximum age: 48 Years. Gender(s): Female.

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.

Locations and Contacts

Yale School of Medicine, New Haven, Connecticut 06510, United States
Additional Information

Starting date: September 2000
Last updated: March 3, 2015

Page last updated: August 23, 2015

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