Varenicline, an Alpha 4 Beta 2 Nicotinic Acetylcholine Receptor Partial Agonist, on Cognitive Dysfunction in 120 Patients With Schizophrenia: a Randomized, Double Blind, 8 Weeks Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 5
- 主要终点
- To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia.
研究概览
简要总结
The primary objective of this project is to examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia. The secondary objective is to evaluate the effect of this combination therapy on smoking in people with schizophrenia. This study will be a randomized, double blind, parallel group, placebo controlled 8 weeks trial.
详细描述
Cognitive deficits have been considered as a core symptom domain of schizophrenia. Amelioration of or improvement in cognitive impairments is becoming an important focus of clinical treatment development. Varenicline is a potent and selective alpha 4 beta 2 nicotinic acetylcholine receptor partial agonist that has been developed for smoking cessation. In animal studies, alpha 4 beta 2 receptor agonists significantly improve working memory and attention function. Subjects will be assigned in 1:1 ratio to receive varenicline or placebo respectively. Assessments will be done using several neuropsychologic tests, clinical rating scale including assessment of nicotine withdrawal scales.Varenicline has been found to be efficacious for smoking cessation in the general population and animal studies have demonstrated the cognitive benefits of this agent. However, no published work is available evaluating the cognitive effects in humans. Thus, patients may experience improvements in cognitive function and in people who are smokers, these people may be able to achieve abstinence in smoking. This will in turn improve long-term functional outcomes and health outcomes in people with schizophrenia. This is an exciting opportunity for discovery if indeed cognitive abilities could be improved with this adjunctive treatment.
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 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable patients with schizophrenia
排除标准
- •Refractory schizophrenia
- •Mental Retardation
- •Serious Medical illness
研究组 & 干预措施
Varenicline
The effect of varenicline on cognitive function of Varenicline(Chantix) is being compared to that of placebo
干预措施: Varenicline(Chantix) (Drug)
Placebo
The effect of placebo comparator is being compared to that of varenicline
干预措施: Placebo (Drug)
结局指标
主要结局
To examine the effects of varenicline treatment used concomitantly with antipsychotic medications, on cognitive dysfunction in people with schizophrenia.
时间窗: 8 weeks
次要结局
- To evaluate the effect of this combination therapy on smoking in people with schizophrenia.(8 weeks)
