Gabapentin in Patients at Clinical Risk for Psychosis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Change in Left CA1 Cerebral Blood Volume (CBV) (MRI Measure)
研究概览
简要总结
The purpose of this study is to test the effects of the drug gabapentin on brain function thought to be important in the development of schizophrenia. Researchers think that treating a brain region with gabapentin (the hippocampus) may reduce the risk for developing schizophrenia.
详细描述
Six week, single site, proof-of concept, randomized double-blind placebo-controlled pilot study to examine the effects of moderate dose gabapentin (3600mg) in n= 100 putatively prodromal patients on hippocampal activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •COPE patient between age of 18-30
- •Capacity to give informed consent
- •Currently using a reliable method of birth control (female) (condom plus spermicide, diaphragm plus spermicide, IUD, birth control pills, norplant, vasectomy in partner)
排除标准
- •Metal implants in body or a history of metal working, or more than one past MRI scan with gadolinium
- •Lifetime diagnosis of asthmatic symptoms within the past 3 years or known sensitivity to contrast agents
- •Lifetime diagnosis of renal failure/disease
- •Acute neurological, neuroendocrine,or medical disorder including renal insufficiency
- •Lifetime diagnosis of hypertension or diabetes
- •Intelligence Quotient (IQ) < 70
- •Acute risk for suicide and/or violence
- •Pregnant, lactating
- •Current abuse of substances (alcohol, cocaine, stimulants, cannabis, opiates, sedative hypnotics)
- •Current use or anticipated need for antipsychotics or mood stabilizers (all antipsychotics, also Depakote, lithium, lamotrigine, pregabalin or any med with a mechanism of action like gabapentin)
- •The Clinical Global Impressions Scale (CGI)-improvement score during study equal to or greater than 6
研究组 & 干预措施
Gabapentin
Gabapentin 3600mg PO daily
干预措施: Gabapentin (Drug)
Placebo
Matching placebo PO daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Left CA1 Cerebral Blood Volume (CBV) (MRI Measure)
时间窗: 6 weeks
Change from 6 week follow up minus baseline of left CA1 CBV (MRI measure) in patients who receive active drug vs. placebo, after 6 weeks of treatment.
次要结局
- Change in Positive, Negative, Disorganization, and General Symptoms Over Time as Measured by the Structured Interview for Psychosis-Risk Syndromes (SIPS)/the Scale of Psychosis-Risk Symptoms (SOPS)(6 weeks)
- Change in Cognitive Function (Hippocampal-dependent Verbal Memory) as Measured by the California Verbal Learning Test-Second Edition (CLVT-II)(6 weeks)
研究者
Scott Small
Professor of Neurology
New York State Psychiatric Institute