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Gabapentin for the Treatment of Neuroleptic-Induced Tremor

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ClinicalTrials.gov Identifier: NCT00533455
Recruitment Status : Terminated (Failure to recruit due to polypharmacy)
First Posted : September 21, 2007
Last Update Posted : September 24, 2007
Sponsor:
Collaborator:
Pfizer
Information provided by:
Minneapolis Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Neuroleptic-Induced Tremor Drug: Gabapentin Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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 Start Date : March 2004
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tremor
U.S. FDA Resources




Primary Outcome Measures :
  1. Reduction of tremor on the UPDR and SAS
  2. Reduction of instrumental measurements of percent tremor and tremor power.

Secondary Outcome Measures :
  1. Reduction of rigidity, bradykinesia, dyskinesia
  2. Improvement in quality of life


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533455


Locations
United States, Minnesota
Minneapols VA Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Pfizer
Investigators
Principal Investigator: Charles E Dean, MD Minneapols VA Medical Center
Study Director: Adityanjee Adityanjee, MD Minneapolis Veterans Affairs Medical Center

Publications:
ClinicalTrials.gov Identifier: NCT00533455     History of Changes
Other Study ID Numbers: 3232-A
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: September 24, 2007
Last Verified: September 2007

Keywords provided by Minneapolis Veterans Affairs Medical Center:
Antipsychotics, tremor

Additional relevant MeSH terms:
Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Gabapentin
gamma-Aminobutyric Acid
Antipsychotic Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents