Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00044083
Status:
TERMINATED
Last Update Posted:
2018-09-27
First Post:
2002-08-16
Brief Title:
Clinical Trial of Tolcapone for Cognition in Schizophrenia
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Randomized Double-Blinded Placebo Controlled Study of the Effects of Tolcapone and Entacapone on Cognitive Function in Patients With Schizophrenia and Normal Controls Based on COMT Genotype
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Scientific Director request to use resources for other studies
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate whether Tolcapone improves cognition in healthy volunteers as well as patients with schizophrenia Talcapone is a drug that has been FDA approved for Attention Deficit Disorder and allegedly increase the amount of the neurotransmitter dopamine in the frontal cortex of the brain
Detailed Description:
Psychopharmacological modulation of the catecholaminergic system can enhance some aspects of cognitive function For example COMT inhibitors can slightly improve working memoryexecutive function Differences in the response between individuals might be related to a number of factors including variations in the genes The recent finding that a polymorphism in the catechol-o-methyl-transferase COMT gene which produces a 4 fold change in enzyme activity accounts for 4 percent of the variance in performance of working memory tasks in humans suggest that COMT genotype may predict response to COMT inhibitors In the present investigation our goal is to examine in normal controls and patients with schizophrenia the effect of a centrally acting tolcapone and of a peripherally acting entacapone COMT inhibitor on cognitive function We predict that both normal controls and patients with schizophrenia with the valval genotype will have a significant though transient improvement in working memory in subjects treated with tolcapone but not in those treated with entacapone Furthermore in conjunction with other NIMH imaging protocols we would like to examine the neurophysiological correlates related to working memory We predict in tolcapone treated subjects improved measures in prefrontal efficiency in subjects and patients specifically with the valval genotype The present protocol will provide new insights on the importance of this genetic polymorphism in the regulation of aminergic-controlled cognitive function in normal individuals Furthermore this protocol will test whether COMT inhibitors offer a new treatment-based on genotype - for cognitive impairment in schizophrenia No IND is required for the present study
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 |
|---|---|---|---|
| NCT00044083 | OTHER | Clinicaltrialsgov | None |
| 02-M-0239 | OTHER | None | None |