Clinical trial NCT00965562: Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
Official title: A Double-blind, Parallel Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premenstrual Syndrome
Keywords: Premenstrual syndrome
PMS
calcium
Lead sponsor: Donaghue Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: Yale University
First posted: 2009-08-25
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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.

Primary outcomes:
measure: Comparison of the Change in IDS Symptom Scores Among Groups
timeFrame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
measure: Comparison of the Change in PMTS Symptom Scores Among Groups
timeFrame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
measure: Comparison of the Change in CGI-S Symptom Scores Among Groups
timeFrame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
measure: Comparison of the Change in DRSP Symptom Scores Among Groups
timeFrame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
measure: Comparison of the Change in CGI Improvement Scores Among Groups
timeFrame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Secondary outcomes:
measure: Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement)
timeFrame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
measure: Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement)
timeFrame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
measure: Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement)
timeFrame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
measure: Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement)
timeFrame: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit
measure: Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement)
timeFrame: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit
measure: Proportion of Patients With PMTS Visit-wise Response to Treatment (50% Improvement)
timeFrame: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Kimberly A Yonkers, MD
role: PRINCIPAL_INVESTIGATOR
References: