Acute D2 Receptor Blockade Induced Neuronal Network Changes in Human Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Repeatable Battery for the Assessment of Neuropsychological Status
研究概览
简要总结
To detect the effect of second-generation antipsychotic drug on the neural activity.
详细描述
To detect functional correlation changes in the brain with anti-psychotic drug administration as compared to placebo, and b.) to measure if these changes correlate with the plasma level of anti-psychotic, and c.) to evaluate if these changes correlate with drug induced symptoms and changes in cognitive function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Between 18 and 60 years of age
- •Subject is competent to provide informed consent
排除标准
- •Mini Mental Status Exam is less than 28
- •Past or current history of any psychotic illness in the subject or in first degree family members
- •Self report of illicit drug use (except marijuana) in the past. Use of marijuana during the last 3 month...
- •Any use of antipsychotic in the past.
- •Any neuro-anatomical lesions on previous brain imaging
- •Any use of D2 receptor blocking agent (such as antiemetics) in the last two weeks.
- •Any use of any psychotropic medications (SSRI, mood stabilizers, benzodiazepines, stimulants) in the last month.
- •MRI contraindications
- •Any cardiovascular or cerebrovascular diseases or conditions that predispose patients to hypotension (eg. dehydration, hypovolemia, antihypertensive medication)
- •Subjects with diabetes mellitus, metabolic syndrome, hepatic or renal impairment, seizure disorder and any neurological disorder
- •QTc interval longer than 450 ms for male and 470 ms for female
- •Subjects who used any medications in the last two weeks (to avoid any possible drug-drug interactions)
- •Pregnancy
- •Individuals who are illiterate and/or visually impaired
研究组 & 干预措施
Risperidone then Placebo
This group will receive 2 mg (>200lbs), 1.5mg (150-200lbs.) or 1 mg (< 150lbs. of risperidone oral solution on the first day and a placebo on the second day.
干预措施: Risperidone (Drug)
Risperidone then Placebo
This group will receive 2 mg (>200lbs), 1.5mg (150-200lbs.) or 1 mg (< 150lbs. of risperidone oral solution on the first day and a placebo on the second day.
干预措施: Placebo (Other)
Placebo then Risperidone
This group will receive a placebo on the first day and 2mg (> 200lbs.), 1.5mg (150-200lbs), or 1 mg (<150lbs.) of risperidone oral solution on the second day
干预措施: Risperidone (Drug)
Placebo then Risperidone
This group will receive a placebo on the first day and 2mg (> 200lbs.), 1.5mg (150-200lbs), or 1 mg (<150lbs.) of risperidone oral solution on the second day
干预措施: Placebo (Other)
结局指标
主要结局
Repeatable Battery for the Assessment of Neuropsychological Status
时间窗: The change of RBANS scores between placebo and treatment conditions on two consecutive days
This will measure the subject's cognitive performance. RBANS is a well-characterized repeatable battery to measure a wide array of cognitive performance in different cognitive domains. We will use Total Score in RBANS: five index scores are computed from the RBANS (immediate memory, language, visuospatial, attention, delayed memory) that are combined to provide the Total Score. The Total Score is expressed as a standardized score normalized to a population mean of 100, with a standard deviation of 15 (possible scores 40-135). Higher scores reflect better performance. More detailed information is available: Randolph C, Tierney MC, Mohr E, Chase TN (June 1998). "The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity". J Clin Exp Neuropsychol. 20 (3): 310-9. doi:10.1076/jcen.20.3.310.823. PMID 9845158. Here we calculated the difference of T-scaled total RBANS score between risperidone day and placebo day in all participants
次要结局
- Simpson-Angus Extrapyramidal Side Effects Scale(2 times on risperidone day and on placebo day)