Gabapentin for the Treatment of Neuroleptic-Induced Tremor

Condition(s) targeted: Neuroleptic-Induced Tremor

Intervention: Gabapentin (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Minneapolis Veterans Affairs Medical Center

Official(s) and/or principal investigator(s):
Charles E Dean, MD, Principal Investigator, Affiliation: Minneapols VA Medical Center
Adityanjee Adityanjee, MD, Study Director, Affiliation: Minneapolis Veterans Affairs Medical Center

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.

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.

Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Reduction of tremor on the UPDR and SAS

Reduction of instrumental measurements of percent tremor and tremor power.

Secondary outcome:

Reduction of rigidity, bradykinesia, dyskinesia

Improvement in quality of life

Detailed description: 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Veterans 18 and older with an observable tremor judged to be caused by exposure to

antipsychotics

Exclusion Criteria:

- 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.

Minneapols VA Medical Center, Minneapolis, Minnesota 55417, United States

Related publications:

Onofrj M, Thomas A, Paci C, D'Andreamatteo G. Gabapentin in orthostatic tremor: results of a double-blind crossover with placebo in four patients. Neurology. 1998 Sep;51(3):880-2.

Starting date: March 2004
Ending date: August 2007
Last updated: September 21, 2007