Treatment of Tardive Dyskinesia With Galantamine
Primary Purpose
Tardive Dyskinesia
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Galantamine
Sponsored by
About this trial
This is an interventional treatment trial for Tardive Dyskinesia focused on measuring Tardive dyskinesia, Galantamine, Cholinesterase inhibitors
Eligibility Criteria
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
Sites / Locations
- Philadelphia VA Medical Center
Outcomes
Primary Outcome Measures
Change in Abnormal Involuntary Movement scale at 3 months.
Secondary Outcome Measures
Change in Simpson-Angus and Barnes Akathisia scales at 3 moths.
Full Information
NCT ID
NCT00164242
First Posted
September 9, 2005
Last Updated
September 9, 2005
Sponsor
Caroff, Stanley N., M.D.
Collaborators
Ortho-McNeil Neurologics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00164242
Brief Title
Treatment of Tardive Dyskinesia With Galantamine
Official Title
Treatment of Tardive Dyskinesia With Galantamine
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Caroff, Stanley N., M.D.
Collaborators
Ortho-McNeil Neurologics, Inc.
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tardive Dyskinesia
Keywords
Tardive dyskinesia, Galantamine, Cholinesterase inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Galantamine
Primary Outcome Measure Information:
Title
Change in Abnormal Involuntary Movement scale at 3 months.
Secondary Outcome Measure Information:
Title
Change in Simpson-Angus and Barnes Akathisia scales at 3 moths.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanley N Caroff, MD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Philadelphia VA Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11816865
Citation
Caroff SN, Campbell EC, Havey J, Sullivan KA, Mann SC, Gallop R. Treatment of tardive dyskinesia with donepezil: a pilot study. J Clin Psychiatry. 2001 Oct;62(10):772-5. doi: 10.4088/jcp.v62n1004.
Results Reference
background
PubMed Identifier
17388711
Citation
Caroff SN, Walker P, Campbell C, Lorry A, Petro C, Lynch K, Gallop R. Treatment of tardive dyskinesia with galantamine: a randomized controlled crossover trial. J Clin Psychiatry. 2007 Mar;68(3):410-5. doi: 10.4088/jcp.v68n0309.
Results Reference
derived
Learn more about this trial
Treatment of Tardive Dyskinesia With Galantamine
We'll reach out to this number within 24 hrs