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Gabapentin for the Treatment of Neuroleptic-Induced Tremor

NCT ID: NCT00533455

Last Updated: 2007-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2007-08-31

Brief Summary

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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

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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.

Conditions

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Neuroleptic-Induced Tremor

Keywords

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Antipsychotics, tremor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Gabapentin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role lead

Principal Investigators

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Charles E Dean, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapols VA Medical Center

Adityanjee Adityanjee, MD

Role: STUDY_DIRECTOR

Minneapolis Veterans Affairs Medical Center

Locations

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Minneapols VA Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 9748048 (View on PubMed)

Other Identifiers

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3232-A

Identifier Type: -

Identifier Source: org_study_id