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Treatment of Tardive Dyskinesia With Galantamine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00164242
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : September 14, 2005
Ortho-McNeil Neurologics, Inc.
Information provided by:
Caroff, Stanley N., M.D.

Brief Summary:
Tardive dyskinesia (TD), a form of movement disorder, remains a problem for some patients who received antipsychotic medications. Increasing evidence suggests that TD may result from antipsychotic-induced dysfunction in striatal cholinergic neurons. To test whether cholinesterase inhibitors compensate for diminished cholinergic activity underlying TD, we conducted a 30-week randomized, double-blind, placebo-controlled crossover study of galantamine in 36 patients with TD.

Condition or disease Intervention/treatment Phase
Tardive Dyskinesia Drug: Galantamine Phase 4

Detailed Description:

BACKGROUND: Tardive dyskinesia (TD) is an infrequent but important complication of treatment with antipsychotic medications. Although newer antipsychotics may be less likely to cause TD, it still occurs among some mentally ill patients previously treated with typical antipsychotics. Although usually mild, TD may be more troublesome in some patients. There is no proven curative or suppressive treatment that is effective in all patients. Suppressive treatment with cholinergic agents derives from a hypothesized balance between dopaminergic and cholinergic neurotransmission in the extrapyramidal system. Although previous trials of cholinergic precursors have been unsuccessful in treating TD, their effect on central cholinergic neurotransmission remains uncertain in view of evidence of damage to striatal cholinergic neurons in patients with TD. In contrast, the recent development of cholinesterase inhibitors that are effective in modifying the central cholinergic deficit in Alzheimer's disease, prompted us to investigate the therapeutic effect of galantamine in patients with TD.

RESEARCH OBJECTIVES: We propose to complete a randomized, double-blind, placebo-controlled crossover trial in 36 patients to test; (1) whether galantamine is pharmacologically active in suppressing TD; (2) whether doses of 8-24 mg/day are sufficient for improvement; (3) whether there are any significant side effects in these patients.

METHODS: Thirty-six patients with abnormal involuntary movements meeting research criteria for TD, who are on stable doses of psychotropic medications, will be randomized to receive galantamine alternating with placebo in addition to their standard medications. After 2 baseline measurements, each patient will undergo 12-week treatment periods of galantamine and placebo with a 4-week washout period between treatments. Patients will be evaluated every 2 weeks throughout the study, using standardized rating scales for TD (AIMS) and other extrapyramidal side effects (SIMPSON, BARNES. During the active treatment period, patients will receive galantamine 4 mg BID for 4 weeks followed by 8 mg BID for 4 weeks, and 12 mg BID for an additional 4 weeks. Placebo-galantamine differences will be examined by repeated measures analysis of covariance for a two-period crossover design.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Treatment of Tardive Dyskinesia With Galantamine
Study Start Date : January 2002
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change in Abnormal Involuntary Movement scale at 3 months.

Secondary Outcome Measures :
  1. Change in Simpson-Angus and Barnes Akathisia scales at 3 moths.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Clinical diagnosis of tardive dyskinesia lasting at least 3 months
  • Treatment with antipsychotic drugs at least for 3 months
  • 18 years old or older

Exclusion Criteria:

  • Significant active medical illness
  • Allergy to galantamine
  • Pregnancy
  • Drug or alcohol dependence
  • Necessary use of anticholinergics or vitamin E

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 identifier (NCT number): NCT00164242

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United States, Pennsylvania
Philadelphia VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Caroff, Stanley N., M.D.
Ortho-McNeil Neurologics, Inc.
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Principal Investigator: Stanley N Caroff, MD Corporal Michael J. Crescenz VA Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00164242    
Other Study ID Numbers: 00347
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: September 14, 2005
Last Verified: September 2005
Keywords provided by Caroff, Stanley N., M.D.:
Tardive dyskinesia
Cholinesterase inhibitors
Additional relevant MeSH terms:
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Tardive Dyskinesia
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Dyskinesia, Drug-Induced
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents