A Randomised, Multi-Centre Study to Compare the Efficacy and Safety of Extended Release Quetiapine Fumarate (Seroquel XR TM) Tablets as Mono-Therapy or in Combination With Lithium in the Treatment of Patients With Acute Bipolar Depression
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 421
- 试验地点
- 1
- 主要终点
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
研究概览
简要总结
The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.
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
- 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
- •Outpatients that meet the diagnostic criteria for bipolar disorder I and bipolar disorder II with the most recent episode depressed
- •The total score of the scale that's used for the evaluation of depression (HAM-D) should be ≥20
- •The total score of the scale that' used for the evaluation of mania (YMRS) should be ≤12
排除标准
- •Patients with a current DSM-IV-TR Axis I disorder other than bipolar disorder within 6 months of enrollment. Patients who pose a current serious suicidal or homicidal risk
- •Use of drugs that induce or inhibit the hepatic metabolizing enzymes within 14 days before randomisation
- •Patients who are unable to discontinue all psychoactive medications, including antidepressants, antipsychotics, and mood stabilizers at least 7 days prior to randomisation and consistent with the pharmacokinetics of the drug
研究组 & 干预措施
Quetiapin fumarate XR
Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
干预措施: Quetiapine fumarate XR (Drug)
Quetiapin fumarate XR+Lithium carbonate
Quetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56.
干预措施: Quetiapine fumarate XR (Drug)
Quetiapin fumarate XR+Lithium carbonate
Quetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56.
干预措施: Lithium carbonate (Drug)
结局指标
主要结局
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
时间窗: Baseline, 8 weeks
The change of MADRS Total Score from baseline to the end of treatment was calculated by subtracting the MADRS Total Score assessed at week 8 from the baseline one (Baseline - 8 weeks). The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
次要结局
- Response Rate for MADRS.(baseline, week 8)
- Hamilton Rating Scale for Depression (HAM-D) Total Score.(Baseline, 8 Weeks)
- Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score(baseline, 8 weeks)
- Change in the Clinical Global Impression Severity (CGI-S) Score.(baseline, 8 weeks)
- Change in Young Mania Rating Scale (YMRS) Total Score.(baseline, 8 weeks)
- Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score.(Baseline, 8 weeks)
- Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score.(baseline, 8 weeks)
- Change in the Sheehan Disability Scale (SDS) Total Score.(baseline, 8 weeks)
- Treatment Satisfaction Questionnaire (TSQ) Scores.(baseline, 8 weeks)