Cognitive and Negative Symptoms in Schizophrenia Trial (CONSIST)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 10
- 主要终点
- change from baseline on neurocognitive battery measured at 16 weeks.
研究概览
简要总结
This study will determine the effectiveness of treatment with glycine or d-cycloserine in addition to a normal antipsychotic regimen in improving negative symptoms and cognitive impairments in patients with schizophrenia.
详细描述
A double-blind, placebo controlled clinical trial to examine whether adjunctive treatment with glycine or d-cycloserine, compared to placebo, will improve negative symptoms and cognitive impairments in patients with schizophrenia who remain on their normal antipsychotic regimen.
Multicenter, randomized, double-blinded placebo controlled parallel-groups clinical trial designed to test the hypothesis that interventions (glycine or d-cycloserine) intended to increase glutamatergic activity by action at the NMDA receptor will reduce persistant negative symptoms and cognitive impairments of patients with schizophrenia or schizoaffective disorder. After an initial screening phase to establish clinical stability and eligibility, patients were assigned to one of three adjunctive treatments (placebo, d-cycloserine or glycine)for 16 weeks of double-blind treatment. Patients remained on a stable dose of antipsychotic therapy (other than clozapine) throughout the study.
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
- 18 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of schizophrenia or schizoaffective disorder
- •stable, enduring negative symptoms above a certain level (SANS >19)
- •clinically stable, with psychotic symptoms measured on BPRS below 19, anxiety/depression on BPRS below 15
- •extrapyramidal symptoms measured on SAS below 9
- •on stable antipsychotic regimen (not including clozapine)
排除标准
- •alcohol or substance dependence within last six months
- •alcohol or substance abuse within last month
- •organic brain disorder
- •medical condition whose pathology or treatment could alter the presentation or treatment of schizophrenia, including active tuberculosis or tuberculosis treatment, kidney stones, and uncontrolled diabetes mellitus
- •Female participants could not be pregnant and were required to be using a documented method of contraception.
结局指标
主要结局
change from baseline on neurocognitive battery measured at 16 weeks.
changes from baseline in negative symptoms measured on SANS at 4,8,12 and 16 weeks.
次要结局
- change in psychotic and depressive symptoms measured at 4,8,12, and 16 weeks.
- changes in extrapyramidal side effects at 4,8,12 and 16 weeks.
研究者
MPRC
P.I.
University of Maryland, Baltimore