A Double-Blind Placebo Controlled Trial of Divalproex and Olanzapine in Bipolar I Disorder, Mixed Episode
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint.
研究概览
简要总结
Whether treatment with olanzapine in combination with mood stabilizer reduces symptoms of both mania and depression more than treatment with mood stabilizer alone, in patients with a mixed episode of bipolar I 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a mixed episode of bipolar I disorder.
- •Have had at least one previous manic or mixed episode associated with bipolar disorder
- •You must be between 18 and 60 years old.
- •You must be able to visit the doctor's office three times in the first week and then once every week for the next five weeks.
- •If you are a female, you must have a negative pregnancy test and be using an effective method of contraception.
排除标准
- •You have a diagnosis of schizophrenia, schizoaffective disorder or substance abuse or dependence.
- •You have diseases of the intestinal tract, lungs, liver, kidney, nervous or endocrine systems, or blood.
- •Have required a recent thyroid hormone supplement to treat hypothyroidism (must have been on a stable dose of the medication for at least 2 months prior to Visit 3).
- •You are allergic to any of the medications involved in this study.
研究组 & 干预措施
1
olanzapine and divalproex
干预措施: olanzapine (Drug)
1
olanzapine and divalproex
干预措施: divalproex (Drug)
2
placebo and divalproex
干预措施: placebo (Drug)
2
placebo and divalproex
干预措施: divalproex (Drug)
结局指标
主要结局
Mean Change in Young Mania Rating Scale (YMRS) Scores From Baseline to Endpoint.
时间窗: Baseline to endpoint (6 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.
Mean Change in Hamilton Depression Rating Scale-21 (HAMD) Scores From Baseline to Endpoint.
时间窗: Baseline to endpoint (6 weeks)
The 21-item HAMD measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60.
次要结局
- Number of Participants Meeting the Criteria for Mixed Onset of Action(Baseline to endpoint (6 weeks))
- Number of Participants Meeting the Criteria for Mixed Response(baseline to endpoint (6 weeks))
- Mean Change in Clinical Global Impression for Bipolar Illness Severity (CGI-BP) From Baseline to Endpoint(Baseline to endpoint (6 weeks))
- Number of Patients Hospitalized Due to Relapse of Mania or Depression.(Baseline to endpoint (6 weeks))
- Clinically Significant Laboratory Values - Fasting Cholesterol Change From Baseline(Baseline to endpoint (6 weeks))
- Clinically Significant Laboratory Values - Fasting Triglycerides Change From Baseline(Baseline to endpoint (6 weeks))
- Clinically Significant Laboratory Values - Fasting Blood Glucose Change From Baseline(Baseline to endpoint (6 weeks))
- Clinically Significant Laboratory Values - Bilirubin Total Change From Baseline(Baseline to endpoint (6 weeks))
- Clinically Significant Vital Signs - Body Mass Index Change From Baseline(Baseline to endpoint (6 weeks))
- Clinically Significant Vital Signs - Weight Change From Baseline(Baseline to endpoint (6 weeks))
- Clinically Significant Vital Signs - Percentage of Participants With Baseline-to-Endpoint Weight Increase of at Least Seven Percent (7%)(Baseline to endpoint (6 weeks))