A 4-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Broad Clinical Benefit for Seroquel XR (Quetiapine Fumarate Extended Release) With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The Proportion of Patients With Improvement From Baseline to Week 4 in Clinical Global Impression-Clinical Benefit Score (LOCF)
研究概览
简要总结
The primary objective of this study is to evaluate the broad clinical benefit of dosing Seroquel XR with flexible in the treatment of acute bipolar mania patients with partial response to existing therapy. Clinical benefit will be assessed with the Clinical Global Impression-Clinical Benefit (CGI-CB) score, according to a classification based on the principles outlined in the CGI efficacy index. Improvement in clinical benefit will be defined as a decrease from baseline in CGI-CB.
详细描述
A 4-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Broad Clinical Benefit for Seroquel XR (Quetiapine Fumarate Extended Release) With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (
- •Bipolar I Disorder, manic or mixed type with/without psychotic feature,
- •Diagnosis should be confirmed by the Mini Inte)
- •Currently on Lithium/Valproate without antipsychotics more than 3 weeks consecutive treatment YMRS total score ≥16 at study entry
排除标准
- •Non-response to antipsychotic treatments for manic symptoms in previous episodes
- •A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria (
- •Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%,
- •Admitted to hospital for treatment of DM or DM related illness in past 12 weeks, etc)
- •An absolute neutrophil count (ANC) of 1.5 x 10^9 per liter
研究组 & 干预措施
Quetiapine XR
Quetiapine fumarate (Seroquel XR)
干预措施: Quetiapine fumarate (Seroquel XR) (Drug)
结局指标
主要结局
The Proportion of Patients With Improvement From Baseline to Week 4 in Clinical Global Impression-Clinical Benefit Score (LOCF)
时间窗: Baseline, week 4
CGI-CB is used to evaluate the investigator's global weighted impression of efficacy and interference of adverse event from baseline to every visit. Improvement in clinical benefit is defined as a decrease from baseline in CGI-CB. Rank 1 denotes best possible benefit from new treatment and rank 10 indicates that there is no benefit from treatment.
次要结局
- The CGI-I (Clinical Global Impression-Improvement of Illness) Change From Baseline to Week 4(Baseline, week 4)
- The Mean Change From Baseline to Week 4 in CGI-S (Clinical Global Impression-Severity of Illness) Score(Baseline, week 4)
- The Mean Change From Baseline to Week 4 in - YMRS (Young Mania Rating Scale) Total Score(Baseline, week 4)