A Randomised, Double-blind, Parallel-group, Explorative Study of the Safety, Tolerability, and Pharmacokinetics of Daily Dosing Compared to Weekly Dosing of Zicronapine in Patients With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 4
- 主要终点
- Number of Patients With Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The main purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of once weekly dosing of zicronapine, compared to daily dosing of zicronapine.
详细描述
The study includes 2 treatment periods. The open-label run-in period will begin at patient enrolment and continue for 3 weeks, during which all patients will receive once daily treatment with zicronapine. The double-blind period will begin at patient randomization and continue for 5 weeks, during which the patients will be assigned to one group receiving once daily treatment with zicronapine and 3 groups receiving once weekly treatment with zicronapine.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR)
- •A score of <=4 (moderately ill) on Clinical Global Impression - Severity of Illness (CGI-S) scale
- •A total score >=60 on Positive and Negative Syndrome Scale (PANSS)
- •A score of <=4 (moderate) on PANSS items: P7 (hostility) AND G8 (uncooperativeness)
排除标准
- •Acute exacerbation requiring hospitalization within the last 3 months OR requiring change of antipsychotic medication within the last 4 weeks
- •Diagnosis or history of substance dependence or substance abuse according to DSM-IV-TR within the last 3 months
- •Significant risk of harming himself/herself or others
- •Positive serology for hepatitis A, B, C, or HIV
- •Present condition that might compromise liver function
- •Medical or neurological disorder or treatment that could interfere with study treatment or compliance
- •Previous exposure to zicronapine
- •Other inclusion and exclusion criteria may apply.
研究组 & 干预措施
Zicronapine open-label lead-in 10 mg daily
干预措施: Zicronapine open-label lead-in 10 mg daily (Drug)
Zicronapine 10 mg daily
干预措施: Zicronapine 10 mg daily (Drug)
Zicronapine 20 mg once weekly
干预措施: Zicronapine 20 mg once weekly (Drug)
Zicronapine 30 mg once weekly
干预措施: Zicronapine 30 mg once weekly (Drug)
Zicronapine 45 mg once weekly
干预措施: Zicronapine 45 mg once weekly (Drug)
结局指标
主要结局
Number of Patients With Adverse Events as a Measure of Safety and Tolerability
时间窗: 11 weeks for open-label period; 13 weeks for double-blind period
Number of patients with treatment-emergent adverse events during each of the two study periods plus corresponding safety follow-up period. Open-label period: 3 weeks post-baseline plus 8 weeks safety follow-up (11 weeks total); Double-blind period: 5 weeks post-randomization plus 8 weeks safety follow-up (13 weeks total)
次要结局
- Positive and Negative Syndrome Scale (PANSS) Total and Subscales Change From Baseline(8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period))
- Clinical Global Impression Improvement Scale (CGI-I)(8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period))
- Clinical Global Impression Severity Scale (CGI-S) Change From Baseline(8 weeks post-baseline (3 weeks open-label period plus 5 weeks double-blind period))