A Double-blind, Parallel Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Comparison of the Change in PMTS Symptom Scores Among Groups
研究概览
简要总结
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.
详细描述
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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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
I
Fluoxetine
干预措施: Fluoxetine (Drug)
II
Calcium
干预措施: Calcium (Drug)
III
干预措施: Placebo (Drug)
结局指标
主要结局
Comparison of the Change in PMTS Symptom Scores Among Groups
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Proportion of Participants With DRSP LOCF Response to Treatment (50% Improvement)(over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit)
- Proportion of Participants With IDS LOCF Response to Treatment (50% Improvement)(over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit)
- 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)
- Proportion of Participants With PMTS LOCF Response to Treatment (50% Improvement)(over duration of treatment, 4 menstrual cycles averaging 4 months after baseline visit)
- 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)
- 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)
研究者
Kimberly Yonkers
Professor
Yale University