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Sponsors and Collaborators: |
Minneapolis Veterans Affairs Medical Center Pfizer |
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Information provided by: | Minneapolis Veterans Affairs Medical Center |
ClinicalTrials.gov Identifier: | NCT00533455 |
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 | Intervention | Phase |
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Neuroleptic-Induced Tremor |
Drug: Gabapentin |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 40 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | 3232-A |
Study First Received: | September 19, 2007 |
Last Updated: | September 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00533455 |
Health Authority: | United States: Federal Government |
Antipsychotics, tremor |
Excitatory Amino Acids Calcium, Dietary Signs and Symptoms Gabapentin |
Neurologic Manifestations Dyskinesias Tremor |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Nervous System Diseases Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Cardiovascular Agents |
Antimanic Agents Pharmacologic Actions Membrane Transport Modulators Sensory System Agents Therapeutic Uses Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Central Nervous System Agents Anticonvulsants Excitatory Amino Acid Antagonists |