Clinical trial NCT00533455: Gabapentin for the Treatment of Neuroleptic-Induced Tremor
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Neuroleptic-Induced Tremor
Keywords: Antipsychotics, tremor
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Pfizer
First posted: 2007-09-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.

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.

Eligibility 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.

Primary outcomes:
measure: Reduction of tremor on the UPDR and SAS
measure: Reduction of instrumental measurements of percent tremor and tremor power.
Secondary outcomes:
measure: Reduction of rigidity, bradykinesia, dyskinesia
measure: Improvement in quality of life
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapols VA Medical Center
state: Minnesota
Study officials:
affiliation: Minneapols VA Medical Center
name: Charles E Dean, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Minneapolis Veterans Affairs Medical Center
name: Adityanjee Adityanjee, MD
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1212/wnl.51.3.880.