NCT00521365已完成4 期
A Phase IV STudy of the Effectiveness of Quetiapine Extended Release 600mg Once a Day to Control the Symptoms of Manic Phase of Bipolar Disorder.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21)
研究概览
简要总结
The primary purpose of the study is to assess the efficacy of Quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to Bipolar disorder. This trial will also assess the life quality and productivity loss improvement for patients from baseline to day 21.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type I Bipolar Disorder in Manic phase according to standard scales and physician criteria.
- •Patients of both genders, aged 18-65 years old being at the first episode
- •Patients with chronic Bipolar Disorder with at least one previous manic episode 6 months before inclusion, that based on the physician experience are in a manic episode at study entry quality
排除标准
- •Psychoactive substance or alcohol abuse or dependence, forbidden medication, pregnancy, rapid cycling patients, intolerance to Quetiapine, clinically severe disease, unstable Diabetes Mellitus, neutropenia, other laboratory abnormalities
研究组 & 干预措施
Quetapine 600 mg
Experimental
干预措施: Quetiapine 600mg (Drug)
结局指标
主要结局
Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21)
时间窗: Baseline and 3 weeks
Change in the YMRS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF), modified intention to treat (mITT) population. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60.
次要结局
- Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3(Baseline and 2 weeks)
- Number of Participants With Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF)(21 days ± 2 days or Last Observation Carried Forward)
- Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2.(Baseline and 1 week)
- Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF).(21 days ± 2 days or Last Observation Carried Forward)
- Change in the Clinical Global Impression (CGI) Total Score From Baseline (CGI-S) to Final Visit or Last Observation Carried Forward (LOCF)(CGI-I).(Baseline and 3 weeks)
- Change in the Quality of Life Questionnaire EQ5D Index From Baseline to End of the Study.(Baseline and 3 weeks)
- Change in the Clinical Global Impression - Improvement (CGI-I) at Final Visit or Last Observation Carried Forward (LOCF).(Baseline and 3 weeks)
- Change in the Quality of Life Questionnaire EQ5D Visual Analogue Scale (VAS) From Baseline to Final Visit or Last Observation Carried Forward (LOCF).(Baseline and 3 weeks)
- Change in Waist Circumference From Baseline to Final Visit or Last Observation Carried Forward (LOCF).(Baseline and 3 weeks)
- Change in the Simpson-Angus Scale (SAS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).(Baseline and 3 weeks)
- Change in the Barnes Akathisia Rating Scale (BARS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).(Baseline and 3 weeks)
- Change in Weight From Baseline to Final Visit or Last Observation Carried Forward (LOCF).(Baseline and 3 weeks)
- Number of Participants With >7% Increase in Weight(Baseline and 3 weeks)
研究者
研究点 (1)
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