Safety and Efficacy of Olanzapine (LY170053) in the Long-term Treatment for Patients With Bipolar I Disorder, Depressed
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Adverse Events Leading to Discontinuation
研究概览
简要总结
To assess the efficacy and safety of olanzapine in the long-term treatment for patients with bipolar I disorder, depressed.
详细描述
This is an open-label, multi-center, long-term treatment study conducted only in Japanese sites. The subjects are patients who fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) (296.50=unspecified, 296.52=moderate severity, 296.53=severe without psychotic features, 296.54=severe with psychotic features), who have completed Study HGMP (NCT#00510146) and patients who did not participate in Study HGMP who have been recruited to participate in Study HGMS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be aged 18 to less than 75 years.
- •Each patient must be reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must understand the nature of the study and have provided informed consent.
- •All female patients must test negative for pregnancy.
- •Females of breast-feeding potential must agree not to breastfeed an infant during the study and for 1 month following the last dose of study drug.
- •Male patients who are not surgically sterilized must agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug.
- •Patients must fulfill the diagnostic criteria for bipolar I disorder, most recent episode depressed, as defined in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR).
- •Patients must have experienced, in the opinion of the investigator, at least one previous manic or mixed episode, as defined in the DSM-IV-TR.
- •Patients must have a current Young Mania Rating Scale (YMRS) Total score =<8.
排除标准
- •Is investigator site personnel directly affiliated with this study or their immediate families.
- •Is a Lilly employee.
- •Has previously completed or withdrawn from this study or any other study investigating olanzapine.
- •Is pregnant or nursing.
- •Has a serious, unstable illness such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months.
研究组 & 干预措施
Pre-Olanzapine
Participants who received olanzapine 5-20 mg/day in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
干预措施: Olanzapine (Drug)
Pre-Placebo
Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
干预措施: Olanzapine (Drug)
New Olanzapine
Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
干预措施: Olanzapine (Drug)
结局指标
主要结局
Percentage of Participants With Adverse Events Leading to Discontinuation
时间窗: Baseline through 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine)
An adverse event (AE) is an untoward medical event associated with the use of the study drug or study procedure, whether or not it is considered related to the study drug or study procedure. Results presented are the percentage of participants who experienced an adverse event that resulted in the discontinuation of the study.
次要结局
- Change From Baseline in Glucose and Lipid Panel at Week 24 or Week 48 Endpoint(baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine))
- Change From Baseline in Weight at Week 24 or Week 48 Endpoint(baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine))
- Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 24 or Week 48 Endpoint(baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine))
- Change From Baseline in Young Mania Rating Scale (YMRS) Total Score at Week 24 or Week 48 Endpoint(baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine))
- Change From Baseline in Clinical Global Improvement- Bipolar (CGI-BP) at Week 24 or Week 48 Endpoint(baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine))
- Percentage of Participants With Emergence of Mania at Week 24 or Week 48(24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine))
- Percentage of Participants With High Suicidality at Week 24 or Week 48(24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine))
- Percentage of Participants With Extra-Pyramidal Symptoms (EPS) at Week 24 or Week 48(24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine))
- Change From Baseline in Hemoglobin (HbA1c) at Week 24 or Week 48 Endpoint(baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine))
- Change From Baseline in Prolactin at Week 24 or Week 48 Endpoint(baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine))
- Change From Baseline to in QTcF at Week 24 or Week 48 Endpoint(baseline, 24 weeks (pre-olanzapine and pre-placebo) or 48 weeks (new olanzapine))