Skip to main content
OpenTrials
Completed

NCT Number: NCT00965562

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Premenstrual Syndrome Menstruation Disturbances Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

About this study

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.

.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Prozac

calcium

Drug

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

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Comparison of the Change in DRSP Symptom Scores Among Groups

    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. 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.

  5. Comparison of the Change in CGI Improvement Scores Among Groups

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

    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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

Sponsors and collaborators

Lead sponsor

Donaghue Medical Research Foundation

Other

Collaborators

  • Yale University

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2010
Study completion
2010
First posted
Aug 25, 2009
Registry last updated
Mar 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.