Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Scores - Olanzapine Monotherapy Arm Only
研究概览
简要总结
The efficacy and safety of the extended treatment to patients with most recent episode manic or mixed who completed previous double blind study (F1D-JE-BMAC [Study BMAC]) will be examined.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled in and completed Study BMAC (NCT00129220), or those who discontinued Study BMAC at Visit 4 or Visit 5 due to lack of efficacy and for whom the Young Mania Rating Scale (YMRS) total score at the time of discontinuation was not lower than that at baseline of Study BMAC
- •Are diagnosed as "294.4x Bipolar I Disorder, Most Recent Episode Manic" or "296.6x Bipolar I Disorder, Most Recent Episode Mixed," as determined by the Mini-International Neuropsychiatric Interview (MINI)
排除标准
- •Have a diagnosis of diabetes mellitus
- •Significant protocol deviation in Study BMAC
- •The actual date of the final visit of Study BMAC is 4 days or more later than the scheduled date of first visit in Study BMEX
研究组 & 干预措施
Olanzapine Monotherapy
Olanzapine extension for Study BMAC patients who completed Visit 8.
Patients received olanzapine 5-20 mg for 18 weeks.
干预措施: olanzapine (Drug)
Olanzapine + Mood Stabilizer
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5.
Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks.
Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
干预措施: olanzapine (Drug)
Olanzapine + Mood Stabilizer
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5.
Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks.
Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
干预措施: lithium (Drug)
Olanzapine + Mood Stabilizer
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5.
Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks.
Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
干预措施: valproate (Drug)
Olanzapine + Mood Stabilizer
Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5.
Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks.
Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
干预措施: carbamazepine (Drug)
结局指标
主要结局
Change From Baseline to Endpoint in Young Mania Rating Scale (YMRS) Total Scores - Olanzapine Monotherapy Arm Only
时间窗: baseline through 18 weeks
The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.
Number of Participants With Response of Manic Symptoms - Olanzapine Monotherapy Arm Only
时间窗: baseline through 18 weeks
Defined by a 50% or more reduction in YMRS total score from baseline in Study BMAC to endpoint. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.
Number of Participants With Remission of Mania - Olanzapine Monotherapy Arm Only
时间窗: baseline through 18 weeks
Remission of Mania was defined as a YMRS total score of less than or equal to 12 at endpoint. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.
Number of Participants With Relapse of Manic Symptoms - Olanzapine Monotherapy Arm Only
时间窗: baseline through 18 weeks
Patients achieved remission in Study BMAC (defined as YMRS total score \<=12 and HAMD-17 total score \<=7) and obtained YMRS total score of \>=15 at any time during Study BMEX. The YMRS is an 11-item scale that measures the severity of manic episodes. Four items are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining items are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). The YMRS total score ranges from 0 to 60. The primary objective was only interested in the effects in the olanzapine monotherapy arm.
次要结局
- Change From Baseline to Endpoint on the YMRS Total Score - Olanzapine + Mood Stabilizer Only(baseline through 18 weeks)
- Clinical Global Impressions - Bipolar Version, Severity of Illness (CGI-BP) Overall, Visit Data(baseline, Weeks 1, 2, 4, 6, 10, 14, 18)
- Number of Participants Who Experienced Switch to Symptomatic Depression as Measured by the Hamilton Depression Scale - 17 Item Version (HAMD-17)(baseline through 18 weeks)
- Number of Participants With Relapse of Depressive Symptoms(baseline through 18 weeks)
- Number of Participants Who Experienced Remission of Bipolar Disorder(Week 18)
- Positive and Negative Syndrome Scale Positive Scores - Visit Data(baseline, Weeks 1, 2, 4, 6, 10, 14, 18)
- Number of Participants Who Switched to Syndromic Depression(baseline through 18 weeks)
- Maximum Change From Baseline to Endpoint on the Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS) - Total Score(baseline through 18 weeks)
- Number of Participants With Treatment-Emergent Parkinsonism Based on DIEPSS Scores(baseline through 18 weeks)
- Number of Participants With Treatment-Emergent Akathisia Based on DIEPSS Scores(baseline through 18 weeks)
- Number of Participants With Treatment-Emergent Dystonia Based on DIEPSS Scores(baseline through 18 weeks)
- Number of Participants With Treatment-Emergent Dyskenisia Based on DIEPSS Scores(baseline through 18 weeks)
- Number of Participants With Potentially Clinically Significant Changes in Laboratory Analytes(baseline through 18 weeks)
- Number of Participants With Potentially Clinically Significant Changes in Vital Signs and Weight(baseline through 18 weeks)
- Number of Participants With Potentially Clinically Significant Changes in Electrocardiograms - High Fridericia Corrected QT Interval (QTcF)(baseline through 18 weeks)
- Number of Participants With Treatment-emergent Abnormal, High, or Low Laboratory Values(baseline through 18 weeks)