Cognitive Effects of Nimodipine in Patients With Schizophrenia
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Brain activity as assessed by BOLD fMRI
研究概览
简要总结
This study aims to evaluate the acute effects of nimodipine on cognitive performance in patients with schizophrenia using a battery of cognitive assessments.The subjects will also complete a 30-minute structural and functional MRI scan, with the goal of linking brain activity with working memory performance. Investigators predict that the performance increase induced by nimodipine will be greater in subjects who carry the A allele for the Calcium Voltage-Gated Channel Subunit Alpha1 C (CACNA1C) risk single nucleotide polymorphism (SNP) (rs1006737) in comparison to the response of G carriers.
详细描述
The main cognitive task of interest in this study is the N-back task because of the observed attenuation of prefrontal and parietal cortical activity after nimodipine administration in healthy subjects. Investigators hypothesize that acute nimodipine administration will improve cortical activation, which will lead to improved cognitive performance. The current study will provide insight whether nimodipine or another calcium channel blocker could be used as a treatment approach to alleviate cognitive deficits in patients with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •This study will recruit patients with schizophrenia and/or schizoaffective disorder
排除标准
- •past or current neurological disorder (including stroke, brain tumor, epilepsy, Alzheimer's, Parkinson's or Huntington's disease)
- •uncontrolled medical disorder
- •current or past hypotension
- •head trauma with loss of consciousness in the last year or any evidence of functional impairment due to and persisting after head trauma
- •positive pregnancy test, or currently breast feeding
- •having an adverse reaction to nimodipine, or other calcium channel blocker
研究组 & 干预措施
Nimodipine
One 60mg capsule of nimodipine on first or second study visit
干预措施: Nimodipine (Drug)
Placebo
One placebo capsule on first or second study visit
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Brain activity as assessed by BOLD fMRI
时间窗: between 30 min and 1 hour after dose
participants will complete an MRI scan to link brain activity with cognitive performance. Measures will be recorded in Arbitrary units.
Changes in Visual Learning and Memory Score
时间窗: approximately an hour after dose
Participants will complete the Brief Visuospatial Memory Task - Revised (BVMT-R) before and after administration of drug or placebo to determine the effect of nimodipine on visuospatial memory in patients with schizophrenia. Scores range from 0 to 60, with higher values indicating better performance. Administration takes approximately 45 minutes to complete (including a 25 minute delay)
Changes in Auditory Learning and Memory Score
时间窗: approximately an hour after dose
During each study visit, participants will complete the Hopkins Verbal Learning Task - Revised (HVLT-R) before and after administration of drug or placebo to determine the effect of nimodipine on verbal learning and memory in patients with schizophrenia. Scores range from 0 to 60, with higher values indicating better performance. Administration takes approximately 35 minutes to complete (including a 20-25 minute delay).
Changes in Global Neurocognitive effect as assessed by the Global Neurocognitive Assessment (GNA)
时间窗: approximately an hour after dose
During each study visit, participants will complete the Global Neurocognitive Assessment (GNA) before and after administration of drug or placebo to determine the effect of nimodipine on a range of neurocognitive measures in patients with schizophrenia. The GNA contains 10 items with varying score ranges. Higher scores indicate better performance.
次要结局
- Effect of CACNA1C genotype on cognitive performance measures(during 2-3 hour study visit)
- Broader genetic associations with cognitive performance(during 2-3 hour study visit)