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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.

Current Primary Outcome:

• Comparison of the Change in IDS Symptom Scores Among Groups [ Time Frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit ]
  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.
• Comparison of the Change in PMTS Symptom Scores Among Groups [ Time Frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit ]
  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.
• Comparison of the Change in CGI-S Symptom Scores Among Groups [ Time Frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit ]
  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.
• Comparison of the Change
  
  

  Original Primary Outcome: 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 ]
  
  

  Current Secondary Outcome:

  • Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement) [ Time Frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit ]
    DRSP: Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme. LOCF: the last observation carried forward.
  • Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement) [ Time Frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit ]
    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=least severe, 84=most severe). LOCF: last observation carried forward.
  • Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement) [ Time Frame: over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit ]
    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). LOCF: last observation carried forward.
  • Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement) [ Time Frame: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit ]
    Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. DRSP = Daily Record of Severity of Problems, which combines responses to 21 items each with scale: 1=no symptoms, 6=extreme.
  • Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement) [ Time Frame: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit ]

    Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit.

    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).

  • Proportion of Patients With PMTS Visit-wise Response to Treatment (50% Improvement) [ Time Frame: over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit ]
    Visit-wise response considers participants who remained in the study until Visit 5 and provided data for the visit. 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).
  
  
  

  Original Secondary Outcome: 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 ]
  
  Information By: Donaghue Medical Research Foundation
  

  Dates:
  Date Received: August 24, 2009
  Date Started: September 2000
  Date Completion:
  Last Updated: March 3, 2015
  Last Verified: February 2015