NCT00931723已完成4 期
An International, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase IV Study of the Safety and Efficacy of Lithium Versus Placebo as an Add on to SEROQUEL XR (Quetiapine Fumarate) in Adult Patients With Acute Mania
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
- 356
- 试验地点
- 1
- 主要终点
- Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)
研究概览
简要总结
The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in treating acute mania and if so, how it compares with placebo (a non-active capsule, like a sugar pill, that looks like lithium).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 before any study procedures are performed.
- •The patient must have a documented clinical diagnosis for bipolar I disorder, including recent episode manic or mixed, and being male of females age 18-65 years, inclusive.
- •Patients may be outpatients or inpatients at enrollment visit, but all patients must be inpatients when randomized and remain inpatients until discharged at the discretion of the investigator.
排除标准
- •The patient can not have had up to 8 mood episodes during the past 12 months and not been continuously hospitalized for acute bipolar for up to 3 weeks immediately before participating in the study.
- •The patient can not have a past diagnosis of stroke or medically documented transient ischemic attacks (TIA) or a history of seizure disorder, except for febrile convulsions.
- •The patient must not have received electroconvulsive treatment (ECT) within 90 days before participating in the study and in the doctors judgement pose a current suicidal or homicidal risk.
研究组 & 干预措施
1
Active Comparator
Seroquel XR and Lithium
干预措施: Quetiapine fumarate XR (Drug)
1
Active Comparator
Seroquel XR and Lithium
干预措施: Lithium (Drug)
2
Placebo Comparator
Seroquel XR and placebo
干预措施: Quetiapine fumarate XR (Drug)
2
Placebo Comparator
Seroquel XR and placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)
时间窗: Change in YMRS total score from baseline to Day 43.
The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).
次要结局
- The Number of Patients With Clinically Significant Response.(43 days (from baseline to Day 43))
- Remission(Days 8 to 43)
- Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness)(Change from baseline to Day 43.)
- Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase)(Change from baseline to Day 43)
- Improvement of Overall Bipolar Illness(Day 43.)
- Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score(Change from baseline to Day 43.)
- Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score(Change from baseline to Day 43)
- Change From Baseline to Day 43 in PANSS Activation Subscale Score(Change from baseline to Day 43)
- Change From Baseline to Day 43 in PANSS Positive Subscale Score(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 1(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 2(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 3(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 4(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 5(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 6(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 7(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 8(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 9(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 10(Change from baseline to Day 43)
- Change From Baseline to Day 43 in Each YMRS Item Score No. 11(Change from baseline to Day 43)
研究者
研究点 (1)
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