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

Primary Purpose

Premenstrual Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Calcium
Placebo
Sponsored by
Donaghue Medical Research Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premenstrual Syndrome focused on measuring Premenstrual syndrome, PMS, calcium

Eligibility Criteria

18 Years - 48 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • Yale School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

I

II

III

Arm Description

Fluoxetine

Calcium

Outcomes

Primary Outcome Measures

Comparison of the Change in IDS Symptom Scores Among Groups
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
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
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 in DRSP Symptom Scores Among Groups
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.
Comparison of the Change in CGI Improvement Scores Among Groups
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 Outcome Measures

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

Full Information

First Posted
August 24, 2009
Last Updated
March 3, 2015
Sponsor
Donaghue Medical Research Foundation
Collaborators
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT00965562
Brief Title
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

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Donaghue Medical Research Foundation
Collaborators
Yale University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome
Keywords
Premenstrual syndrome, PMS, calcium

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Active Comparator
Arm Description
Fluoxetine
Arm Title
II
Arm Type
Active Comparator
Arm Description
Calcium
Arm Title
III
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Other Intervention Name(s)
Prozac
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Calcium
Intervention Description
1200 mg of calcium to be taken for 5 menstrual cycles.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
Comparison of the Change in IDS Symptom Scores Among Groups
Description
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.
Time Frame
over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Title
Comparison of the Change in PMTS Symptom Scores Among Groups
Description
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.
Time Frame
over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Title
Comparison of the Change in CGI-S Symptom Scores Among Groups
Description
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.
Time Frame
over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Title
Comparison of the Change in DRSP Symptom Scores Among Groups
Description
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.
Time Frame
over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Title
Comparison of the Change in CGI Improvement Scores Among Groups
Description
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.
Time Frame
over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Secondary Outcome Measure Information:
Title
Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement)
Description
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.
Time Frame
over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Title
Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement)
Description
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.
Time Frame
over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Title
Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement)
Description
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.
Time Frame
over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit
Title
Proportion of Participants With DRSP Visit-wise Response to Treatment (50% Improvement)
Description
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.
Time Frame
over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit
Title
Proportion of Patients With IDS Visit-wise Response to Treatment (50% Improvement)
Description
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).
Time Frame
over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit
Title
Proportion of Patients With PMTS Visit-wise Response to Treatment (50% Improvement)
Description
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).
Time Frame
over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
48 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly A Yonkers, MD
Organizational Affiliation
Yale School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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