NCT01256177已完成3 期
A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 361
- 试验地点
- 1
- 主要终点
- Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
研究概览
简要总结
The primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(XR) mono-therapy, administered once daily compared to placebo, in the treatment of depressive symptoms in patients with Bipolar I and Bipolar II 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
- Double (Participant, Investigator)
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
- •Provision of informed consent prior to any study specific procedures
- •Male and female patients, aged 18 to 65 years, inclusive.
- •Meets Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria for bipolar disorder I or bipolar II, most recent episode depressed (296.5x and 296.89x).
- •Hamilton Rating Scale for Depression (HAM-D) (17-item) total score of ≥ 20 and HAM-D item 1 (depressed mood) score ≥ 2 at enrolment and randomisation.
- •Patients must be able to understand and comply with the requirements of the study,as judged by the Investigator
排除标准
- •Patients with a current Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) diagnosis other than bipolar disorder
- •Patients whose Young Mania Rating Scale (YMRS) total score >12 at enrolment and randomisation.
- •Patients with >8 mood episodes during the past 12 months at enrolment.
- •Patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrolment.
- •Patients with a history of non-response to an adequate treatment (6 weeks) with more than 2 classes of antidepressants during their current episode.
- •Alcohol or other substance dependence or abuse as defined by Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria at enrolment that is not in extended full or extended partial remission (12 months or longer), except caffeine and nicotine dependence.
- •Patients who, in the Investigator's judgment, pose a current serious suicidal or homicidal risk, have a Hamilton Rating Scale for Depression (HAM-D) item 3 score ≥ 3, or have made a suicide attempt within the past 6 months.
研究组 & 干预措施
1
Experimental
干预措施: Quetiapine Fumarate (SEROQUEL) Extended Release (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
时间窗: Baseline to Week 8
MADRS total score range: 0 to 60, the higher the score, the more severe, Change : Total MADRS score at week 8 minus score at baseline
次要结局
- Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S)(Baseline to Week 8)
- The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of "Much" or "Very Much" Improved(After 8 weeks of start of treatment)
- Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation(Baseline to Week 8)
- Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment)(After 8 weeks of start of treatment)
- Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)(After 8 week of start of treatment)
- Change From Baseline to Each Assessment in MADRS Total Score(Baseline to Week 8)
- Change From Baseline to Week 8 in HAM-D Total Scores(Baseline to Week 8)
- Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score)(8 weeks from baseline)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the TreatMajor Depressive DisorderGeneralized Anxiety DisorderNCT01971203Icahn School of Medicine at Mount Sinai62
已完成
3 期
Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar DepressionBipolar DisorderNCT00083954AstraZeneca530
已完成
3 期
Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR) in the Treatment of Major Depressive DisordersMajor Depressive DisorderNCT00326144AstraZeneca310
已完成
3 期
Efficacy & Safety of Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With SchizophreniaSchizophreniaNCT00085891AstraZeneca535
已完成
3 期
Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic PatientsSchizophreniaNCT00882518AstraZeneca388