A 24-Week, Multicenter, Double-Blind, Randomized, Parallel-Group, Dose Ranging Study of the Efficacy and Safety of 3 Oral Doses of AVE1625 and Placebo on Top of Either Olanzapine, Risperidone/Paliperidone, Quetiapine or Aripiprazole in the Treatment of Cognitive Impairment in Schizophrenia.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Sanofi
- 入组人数
- 873
- 试验地点
- 1
- 主要终点
- Change from baseline in the MATRICS Cognitive Battery composite standardized score
研究概览
简要总结
AVE1625 is a new potent and selective cannabinoid 1 (CB1) antagonist in clinical development for the treatment of cognitive impairment in patients diagnosed with schizophrenia.
The main objective of this study is to evaluate the efficacy on cognitive impairment of 3 doses of AVE1625 using a new cognitive battery called Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) in schizophrenic patients.
The secondary objectives are to measure the efficacy of AVE1625 on functional capacity of the patients using a specific scale called University of California San Diego Performance-based Skills Assessment 2 (UPSA2) and to assess the safety of the compound.
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 (Participant, Investigator)
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
- •Outpatients with diagnosis of schizophrenia (diagnosed ≤ 35 years of age).
- •Current treatment consisting exclusively of olanzapine, risperidone/paliperidone, quetiapine or aripiprazole monotherapy for at least 2 months.
排除标准
- •Inpatient hospitalization within past 3 months.
- •Residence at the current address < 3 months due to any instability in the disease.
- •Presence of depressive symptoms.
- •Past history of clinically significant violent behavior.
- •Substance dependence or abuse.
- •Pregnant or breast-feeding women or women not protected by effective contraceptive method of birth control.
- •The investigator will evaluate whether there are other reasons why a patient may not participate.
研究组 & 干预措施
Placebo
干预措施: placebo (Drug)
AVE1625 dose level 1
干预措施: AVE1625 (Drug)
AVE1625 dose level 2
干预措施: AVE1625 (Drug)
AVE1625 dose level 3
干预措施: AVE1625 (Drug)
结局指标
主要结局
Change from baseline in the MATRICS Cognitive Battery composite standardized score
时间窗: at week 24
次要结局
- Change from baseline in the UPSA2 total score(at week 24)
- Safety: physical examination, vital signs, ECGs, laboratory parameters, adverse events(study period)
- Additional scales used for schizophrenia(at week 24)