A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Oral Multiple Ascending Doses of AZD0328 in Patients With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) Standardized Composite Score at Day 14
研究概览
简要总结
This study is to assess the pharmacodynamics, pharmacokinetics, safety and tolerability of multiple ascending doses of AZD0328 in patients with schizophrenia
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of schizophrenia according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition)
- •Low level of Extra-pyramidal symptoms
- •No clinically significant findings on physical examination
排除标准
- •Diagnosis of schizoaffective or schizophreniform disorders
- •Any significant psychiatric or neurological disease other than schizophrenia
研究组 & 干预措施
1
AZD0328 low dose
干预措施: AZD0328 (Drug)
2
AZD0328 Optimal dose
干预措施: AZD0328 (Drug)
3
AZD0328 High dose
干预措施: AZD0328 (Drug)
4
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
CogState Groton Maze Learning Task (GMLT) and One Card Learning Task (OCLT) Standardized Composite Score at Day 14
时间窗: Baseline and Day 14
The GMLT and OCLT standardized change composite score will be calculated as the mean of the GMLT and OCLT standardized change from baseline scores. Least square means were derived using a mixed effects repeated measures model with protocol scheduled assessment day, treatment group, baseline score, and assessment day-by-treatment interaction as fixed factors, center as a random factor, and baseline score as a covariate. Scale range from negative infinity (worst value) to positive infinity (best value).
次要结局
- CogState Groton Maze Learning Task (GMLT) Standardized Change Score at Day 14(Baseline and Day 14)
- CogState One Card Learning Task (OCLT) Standardized Change Score at Day 14(Baseline and Day 14)
- CogState Detection Task (DT) Standardized Change Score at Day 14(Baseline and Day 14)
- CogState Identification Task (IT) Standardized Change Score at Day 14(Baseline and Day 14)
- CogState Groton Maze Recall Task (GMRT) Standardized Change Score at Day 14(Baseline and Day 14)