Effectiveness of Quetiapine XR Versus Sertraline in Acute Depression as add-on Therapy to Previous Mood Stabilizer Treatment: a Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
Prospective, open-label, controlled (active comparator), randomized study of 8 weeks follow-up for the evaluation of the efficacy of extended release quetiapine (quetiapine XR) versus Sertraline in addition to previous mood stabilizer treatment (lithium or valproate at stable and clinically therapeutic blood levels) in the treatment of the adult bipolar depression. This multicentric study will be featured in two sites in Spain.
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
- •Adult ambulatory patients diagnosed of bipolar disorder I or II, current depressive episode (DSM-IV-TR 4ª Ed: 296.5x or 296.89 codes)
- •Have been treated with only one mood stabilizer (lithium or valproate) in optimal and stable doses during at least the previous 4 weeks to randomization
- •Hamilton Depression Rating Scale (HDRS-17) total score ≥ 20 and Young Mania Rating Scale (YMRS) total score ≤ 14 at the screening and randomization visits - Informed consent signed
排除标准
- •Patients with any axis I or II Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) diagnoses different from bipolar disorder I or II - Length of current depressive episode less than 2 weeks or more than 12 months
- •Having been treated with more than one mood stabilizer or any mood stabilizer other than Lithium or valproate, any antidepressant, any antipsychotic or any CP450-3A inductor/inhibitor within the 7 days period prior to randomization
研究组 & 干预措施
Quetiapine Extended Release
Lithium or valproate at stable doses within seric therapeutic levels
干预措施: Extended release quetiapine (quetiapine XR) (Drug)
Quetiapine Extended Release
Lithium or valproate at stable doses within seric therapeutic levels
干预措施: adequate mood stabilizer (Drug)
Sertraline
Lithium or valproate at stable doses within seric therapeutic levels
干预措施: Sertraline (Drug)
Sertraline
Lithium or valproate at stable doses within seric therapeutic levels
干预措施: adequate mood stabilizer (Drug)
结局指标
主要结局
The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
时间窗: baseline, week 2
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)
次要结局
- The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score(baseline, week 1)
- The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score(baseline, week 4)
- The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score(baseline. week 8)
- The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score(baseline, week 1)
- The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score(baseline, week 2)
- The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score(baseline, week 4)
- The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score(baseline, week 8)
- The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score(baseline, week 4)
- The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score(baseline, week 8)
- Number of Patients Response at Week 1(week 1)
- Number of Patients With Response at Week 2(week 2)
- Number of Patients With Response at Week 4.(week 4)
- Number of Patients With Response at Week 8.(week 8)
- Number of Patients With Remission at Week 1.(week 1)
- Number of Patients With Remission at Week 2.(week 2)
- Number of Patients With Remission at Week 4.(week 4)
- Number of Patients With Remission at Week 8.(week 8)