A 4 Week, Parallel-Design, Double-Blind, Placebo-Controlled Trial of Gabapentin in the Treatment of Neuroleptic-Induced Tremor: Clinical and Instrumental Ratings of Outcome.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Reduction of tremor on the UPDR and SAS
研究概览
简要总结
We will attempt to establish whether gabapentin as compared with placebo will reduce the severity of tremors caused by the use of antipsychotic medications. Baseline severity of tremor will be measured using both clinical ratings and ratings obtained with an instrument designed to measure tremor, giving more objective evidence of tremor frequency and severity.
详细描述
We propose to enroll 40 veterans with antipsychotic induced tremor in this RCT of gabapentin. Baseline measurements will be obtained with the tremor section of the UPDRS, the Simpson-Angus Scale, the ESRS, AIMS, and the Barnes Akathisia SScale. The Tremorometer, an instrument designed to quantatatively measure frequency, amplitude, and tremor power will be used for baseline and subsequent assessments. Demographic data will be collected. Diagnoses will be established with the SCID. Appropriate lab studies with an EKG will be done at baseline and at study end. Patients will be randomized to gabapentin or placebo and assessed on a blinded basis. Effectiveness of the blind will be assessed at study end. Gabapentin will be started at 300 mg/day and tapered up to a maximum of 1800 mg/day. The SF36 will be used to assess quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans 18 and older with an observable tremor judged to be caused by exposure to antipsychotics
排除标准
- •Concomitant use of other anticonvulsants, L-Dopa, cocaine, amphetamines, or other tremorogenic agents excepting SSRIs, TCAs.
- •Current suicidality, severe psychosis, inability to sign informed consent or to cooperate with study procedures.
- •Current use of gabapentin or exposure to gabapentin in the past 2 years.
- •Women who are pregnant, or not using adequate birth control.
结局指标
主要结局
Reduction of tremor on the UPDR and SAS
Reduction of instrumental measurements of percent tremor and tremor power.
次要结局
- Reduction of rigidity, bradykinesia, dyskinesia
- Improvement in quality of life