NCT00485680已完成3 期
Olanzapine Versus Lithium Carbonate in the Treatment of Bipolar Disorder, Manic or Mixed Episodes
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Investigate the efficacy of olanzapine once a day orally for 4 weeks to Lithium Carbonate orally in the treatment of Chinese patients with bipolar I disorder, manic or mixed episodes, with or without psychotic features as measured by the CGI-BP Severity
研究概览
简要总结
The purpose of this trial is compare the efficacy of olanzapine and Lithium Carbonate in the treatment of bipolar disorder, manic or mixed episodes, in Chinese patients.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female in- or out-patients at least 18 years of age
- •Patient must have a diagnosis of bipolar I disorder and currently display acute manic or mixed episodes (with or without psychotic features) according to the DSM-IV based on clinical assessment
- •Patients must have a level of understanding sufficient to agree to all tests and examinations required by the protocol
- •Patients must have a Y-MRS total score of greater than or equal to 20 at both visits 1 & 2
- •Patients must be considered reliable
排除标准
- •Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry
- •Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months
- •Current or past diagnosis of schizophrenia or other psychotic disorder (including schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, shared psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV
- •Documented history of intolerance to olanzapine or Lithium Carbonate
- •Treatment with clozapine within 4 weeks prior to visit
- •Treatment with other antipsychotic drugs or mood stabilizers within 2 days prior to visit 2
结局指标
主要结局
Investigate the efficacy of olanzapine once a day orally for 4 weeks to Lithium Carbonate orally in the treatment of Chinese patients with bipolar I disorder, manic or mixed episodes, with or without psychotic features as measured by the CGI-BP Severity
次要结局
- Assess the efficacy of olanzapine compared with Lithium Carbonate in improving clinical symptomatology in patients diagnosed with bipolar disorder, manic or mixed episodes after acute treatment as measured by the Y-MRS
- Assess the safety of olanzapine compared with Lithium Carbonate. Treatment-emergent adverse events, change in vital signs, laboratory analytes and ECG will be measured.
- Assess the efficacy of olanzapine compared with Lithium Carbonate in improving clinical symptomatology in patients diagnosed with bipolar disorder, manic or mixed episodes after acute treatment as measured by the BRPs, MADRS.
研究者
研究点 (1)
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