Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057707
Status:
COMPLETED
Last Update Posted:
2019-12-09
First Post:
2003-04-05
Brief Title:
Effects of Modafinil on Brain Function in Patients With 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 Modafinil on Cognitive Function in Patients With Schizophrenia and Normal Controls Based on COMT Genotype
Status:
COMPLETED
Status Verified Date:
2017-06-16
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:
This study will evaluate whether modafinil improves cognition in patients with schizophrenia and healthy volunteers Modafinil is a drug that has been FDA approved for day-time sleepiness 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 Similarly modafinil a catecholaminergic agonist that increases extracellular dopamine in the prefrontal cortex was also shown to improve delay-dependent working memory 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 of the variance in performance of working memory tasks in humans suggest that COMT genotype may predict response to COMT inhibitors or to other agonists that increase catecholaminergic function in the frontal cortex
In the present investigation our goal is to examine in normal controls and patients with schizophrenia the effect of modafinil a drug that increases DA output in the frontal cortex on cognitive function and brain physiology We predict that both normal controls and patients with schizophrenia with the valval genotype will have a significant improvement in working memory compared with individuals possessing other genotypes Furthermore in conjunction with other NIMH imaging protocols we predict that modafinil will produce a similar genotype-dependent effect on the neurophysiological correlates related to working memory assayed with fMRI 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 modafinil offers a new treatment -based on genotype - for cognitive impairment in schizophrenia The FDA granted a waiver for the use of Modafinil in this study
In the present investigation our goal is to examine in normal controls and patients with schizophrenia the effect of modafinil a drug that increases DA output in the frontal cortex on cognitive function and brain physiology We predict that both normal controls and patients with schizophrenia with the valval genotype will have a significant improvement in working memory compared with individuals possessing other genotypes Furthermore in conjunction with other NIMH imaging protocols we predict that modafinil will produce a similar genotype-dependent effect on the neurophysiological correlates related to working memory assayed with fMRI 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 modafinil offers a new treatment -based on genotype - for cognitive impairment in schizophrenia The FDA granted a waiver for the use of Modafinil in this 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 |
|---|---|---|---|
| 03-M-0143 | None | None | None |