Gabapentin for the Treatment of Neuroleptic-Induced Tremor
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Purpose
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 |
|---|---|---|
|
Neuroleptic-Induced Tremor |
Drug: Gabapentin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind |
| 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. |
- Reduction of tremor on the UPDR and SAS
- Reduction of instrumental measurements of percent tremor and tremor power.
- Reduction of rigidity, bradykinesia, dyskinesia
- Improvement in quality of life
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| 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 |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00533455 History of Changes |
| Other Study ID Numbers: | 3232-A |
| Study First Received: | September 19, 2007 |
| Last Updated: | September 21, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by Minneapolis Veterans Affairs Medical Center:
|
Antipsychotics, tremor |
Additional relevant MeSH terms:
|
Tremor Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Antipsychotic Agents Gabapentin Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Analgesics |
Sensory System Agents Peripheral Nervous System Agents Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Antimanic Agents |
ClinicalTrials.gov processed this record on May 23, 2013