NCT00051298已完成3 期
Olanzapine Versus Placebo in the Treatment of Adolescents With Schizophrenia
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 26
- 主要终点
- Assess the efficacy of a flexible dose of olanzapine compared to placebo in the treatment of adolescents (ages 13 - 17) with schizophrenia using the BPRS-C
研究概览
简要总结
This study is to determine the efficacy (how well the drug works), safety, and any side effects of olanzapine compared to placebo in the treatment of schizophrenia in adolescents. Both the potential benefits and side effects of olanzapine will be evaluated throughout this trial.
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
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are male or female patients, 13 to 17 years of age
- •Patients must have a diagnosis of schizophrenia per DSM-IV-TR.
- •Female patients of child-bearing potential must test negative for pregnancy at the time of enrollment.
- •Both the patient and the patient's parent/authorized legal representative must understand the nature of the study and must sign a document granting consent.
- •Patients must be capable of swallowing study medication whole (without crushing, dissolving, etc.)
排除标准
- •Female patients who are either pregnant or nursing.
- •Patients with acute or unstable medical conditions.
- •Patients who have been judged clinically to be at serious suicidal risks.
- •Patients who have previously not responded to an adequate dose and/or duration of olanzapine treatment.
- •Patients who currently have delusional disorder, psychotic disorder NOS, schizophreniform, schizoaffective disorder, bipolar disorder, attention deficit/hyperactivity disorder or major depressive disorder.
结局指标
主要结局
Assess the efficacy of a flexible dose of olanzapine compared to placebo in the treatment of adolescents (ages 13 - 17) with schizophrenia using the BPRS-C
次要结局
- Assess secondary efficacy measures to capture additional evidence of efficacy utilizing the CGI-I, CGI-S, PANSS and OAS
- Assess the safety of olanzapine compared with placebo for up to 6 weeks of double-blind treatment and for up to an additional 26 weeks of open-label olanzapine treatment.
- Assess the health-related quality of life and cognition associated with olanzapine compared with placebo for up to 6 weeks of double-blind treatment and for up to an additional 26 weeks of open-label olanzapine treatment.
- Assess the efficacy of olanzapine compared with placebo in improving clinical symptomatology in terms of rate of response
研究者
研究点 (26)
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