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

Not Applicable

Completed

Conditions: Premenstrual Syndrome

Interventions: Drug: Calcium
Drug: Fluoxetine
Drug: Placebo

Registration Number: NCT00965562

Lead Sponsor: Donaghue Medical Research Foundation

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.

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Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 49

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
II	Calcium	Calcium
I	Fluoxetine	Fluoxetine
III	Placebo	-

Primary Outcome Measures

Name	Time	Method
Comparison of the Change in PMTS Symptom Scores Among Groups	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 IDS Symptom Scores Among Groups	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 CGI-S Symptom Scores Among Groups	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 in DRSP Symptom Scores Among Groups	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.
Comparison of the Change in CGI Improvement Scores Among Groups	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 Outcome Measures

Name	Time	Method
Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement)	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)	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 Patients With PMTS Visit-wise Response to Treatment (50% Improvement)	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).
Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement)	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)	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)	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).