A Placebo-Controlled Trial of CX516 (Ampakine) Added to Clozapine, Olanzapine or Risperidone in Patients With Schizophrenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- 1. Evaluate the effects of a four-week trial of CX516 900 mg tid compared to placebo upon verbal memory and attention (DCPT, CVLT, Letter-number sequencing) assessed as part of a standard cognitive battery.
研究概览
简要总结
The purpose of this study is to evaluate the effects of a four-week trial of CX516 900mg tid compared to placebo upon verbal memory, attention and negative symptoms. The AMPA receptor positive modulator, CX516, will be added to a stable dose of clozapine, olanzapine or risperidone in inpatients and outpatients with schizophrenia. The trial is intended to extend and replicate results from our previous placebo-controlled pilot trial of CX516 added to clozapine in which the investigators found improvement in memory and attention (moderate-to-large between group effect sizes) and did not observe serious side effects. Because the investigators' pilot trial also detected at two-week follow-up persistence of cognitive benefits and emergence of a large therapeutic effect upon negative symptoms, this trial will also repeat clinical and cognitive assessments at follow-up, four weeks after completion of the study medication to evaluate persistence and/or strengthening of effects.
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）
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Schizophrenia, any subtype
- •Ages 18-65 years
- •Capable of providing informed consent
- •Stable dose of clozapine, olanzapine or risperidone for at least 6 months
排除标准
- •Serious medical or neurological illness (unstable cardiac disease, seizure disorder, malignancy, liver or renal impairment, etc.)
- •Current substance abuse
- •Pregnancy, nursing, or unwilling to use appropriate birth control measures during participation if female and fertile
- •Unable to complete neuropsychological tests
- •History of serious blood dyscrasia requiring discontinuation of clozapine
- •Serious suicidal or homicidal risk within the past six months
结局指标
主要结局
1. Evaluate the effects of a four-week trial of CX516 900 mg tid compared to placebo upon verbal memory and attention (DCPT, CVLT, Letter-number sequencing) assessed as part of a standard cognitive battery.
2. Evaluate the effects of CX516 compared to placebo on negative symptoms measured by the SANS total score.
3. Evaluate tolerability and adverse effects measured by the AIMS and SAFTEE Scales.
4. Evaluate persistence and/or strengthening of effects 4 weeks after completion of the 4-week trial.
次要结局
未报告次要终点