A Randomized, Double-Blind, Placebo-Controlled Clinical Study of the Efficacy and Safety of Risperidone for the Treatment of Schizophrenia in Adolescents
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 主要终点
- Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 6-week endpoint
研究概览
简要总结
A clinical study to evaluate the efficacy, safety and tolerability of two dose ranges of risperidone (1 to 3 mg/day, and 4 to 6 mg/day) versus placebo (an inactive substance like a sugar pill) in adolescents (aged 13 to 17 years) with schizophrenia (i.e. abnormal behavior and thoughts). The study duration is about 6 to 7 weeks.
详细描述
Subjects will be aged 13 to 17 years with a diagnosis of schizophrenia. On enrollment, subjects will be assigned to receive 1 of 3 treatments (oral placebo tablets, oral risperidone tablets 1 to 3 mg, or oral risperidone tablets 4 to 6 mg), which will be administered daily for 6 weeks. Study medication will be increased to within the target dosage range during the first 7 days and then further increased until the maximum tolerated dose is achieved by day 14. The maximum tolerated dose will be maintained for the last 4 weeks of the study, unless dose adjustments are agreed with the Sponsor. Risperidone (1 to 3 mg or 4 to 6 mg) or placebo given orally as 0.5, 1, 2, 3, or 4 ,g tablets (or matching placebo) each day for 6 weeks.
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
- •A responsible person must be available to accompany the subject to the site at each visit
- •patient must meet the DSM-IV criteria for schizophrenia
排除标准
- •Patients with mild, moderate or severe mental retardation
- •patients with a known or suspected history of substance dependence
- •subjects weighing <35kg
- •subjects who cannot swallow oral tablets
结局指标
主要结局
Change in total PANSS (Positive and Negative Syndrome Scale for Schizophrenia) from baseline to the 6-week endpoint
次要结局
- Change from baseline in PANSS subscale scores and Clinical Global Impression (CGI-S and CGI-I) scores, number of subjects achieving a clinical response (at least 20% improvement in total PANSS), safety and tolerability.