Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164242
Status:
COMPLETED
Last Update Posted:
2005-09-14
First Post:
2005-09-09
Brief Title:
Treatment of Tardive Dyskinesia With Galantamine
Sponsor:
Caroff Stanley N MD
Organization:
Caroff Stanley N MD
Study Overview
Official Title:
Treatment of Tardive Dyskinesia With Galantamine
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Alzheimers 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 mgday 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
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 mgday 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00347 | None | None | None |