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

Donaghue Medical Research Foundation

Status: Completed

Conditions: Premenstrual Syndrome

Treatments: Drug: Fluoxetine; Drug: Calcium; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00965562

0001011511

Details and patient eligibility

About

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.

Full 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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Enrollment: 49 patients

Sex: Female

Ages: 18 to 48 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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49 participants in 3 patient groups, including a placebo group

I

Active Comparator group

Description:

Fluoxetine

Treatment:

Drug: Fluoxetine

II

Active Comparator group

Description:

Calcium

Treatment:

Drug: Calcium

III

Placebo Comparator group

Treatment:

Drug: Placebo