Premenstrual Syndrome Clinical Trial
Official title:
A Double-blind, Parallel Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
Verified date | February 2015 |
Source | Donaghue Medical Research Foundation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 49 |
Est. completion date | October 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 48 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Yale School of Medicine | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Donaghue Medical Research Foundation | Yale University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | No |
Primary | 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. | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | No |
Primary | 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. | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | No |
Primary | 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. | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | No |
Primary | 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. | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | No |
Secondary | 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. | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | No |
Secondary | 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. | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | No |
Secondary | 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. | over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit | No |
Secondary | 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. | over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit | No |
Secondary | 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). |
over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit | No |
Secondary | 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). | over duration of treatment from baseline to visit 5, including 4 menstrual cycles averaging 4 months after baseline visit | No |
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