Gabapentin for the Treatment of Neuroleptic-Induced Tremor
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
|Official Title:||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.|
- Reduction of tremor on the UPDR and SAS
- Reduction of instrumental measurements of percent tremor and tremor power.
- Reduction of rigidity, bradykinesia, dyskinesia
- Improvement in quality of life
|Study Start Date:||March 2004|
|Study Completion Date:||August 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533455
|United States, Minnesota|
|Minneapols VA Medical Center|
|Minneapolis, Minnesota, United States, 55417|
|Principal Investigator:||Charles E Dean, MD||Minneapols VA Medical Center|
|Study Director:||Adityanjee Adityanjee, MD||Minneapolis Veterans Affairs Medical Center|