Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00338598
Status:
COMPLETED
Last Update Posted:
2018-01-17
First Post:
2006-06-15
Brief Title:
Facilitation of NMDA Receptor Function in Patients With Schizophrenia and Co-morbid Alcoholism
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Facilitation of NMDA Receptor Function in Patients With Schizophrenia and Co-morbid Alcoholism
Status:
COMPLETED
Status Verified Date:
2018-01
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 placebo-controlled study is designed to evaluate the efficacy of glycine an agonist of the glycine-B co-agonist site of the NMDA receptor on alcohol consumption and craving as well as negative symptoms in schizophrenia
Glycine will decrease the rewarding action of ethanol and reduce ethanol consumption Also glycine will improve negative symptoms and cognitive deficits in schizophrenia
Glycine will decrease the rewarding action of ethanol and reduce ethanol consumption Also glycine will improve negative symptoms and cognitive deficits in schizophrenia
Detailed Description:
OBJECTIVE Schizophrenia affects about 1 of the general population and is a highly disabling disease Additionally the rate of alcohol dependency for patients with schizophrenia is very high There are no established treatments for alcohol dependency and negative symptoms in schizophrenia This study will examine whether the addition of glycine to neuroleptic medications will help patients with schizophrenia and alcoholism decrease their drinking as well as improve negative symptoms
RESEARCH PLAN An abnormality of the glutamate neurotransmitter system has been hypothesized for both alcoholism and schizophrenia Studies suggest that the amino acid glycine may improve alcohol dependency and symptoms of schizophrenia by acting on the N methyl D aspartate NMDA glutamate receptor Glycine causes reversal of the effects of ethanol in animal studies and improves mood social withdrawal and other so called negative symptoms of schizophrenia Consequently the use of glycine by patients with schizophrenia and alcohol dependency may potentially decrease alcohol craving and alcohol consumption and also improve certain symptoms of schizophrenia The potential of glycine to improve both alcohol dependency and negative symptoms could represent an important step in the improvement of the quality of life for patients with schizophrenia
METHODOLOGYFINDINGSRESULTS In order to test this hypothesis we will use a double blind placebo controlled study and measure the number of drinks the degree of craving for alcohol and symptoms of schizophrenia among other parameters Our principal approach to analyses of medication effectiveness will be the application of the linear mixed effect model The linear mixed effect model permits a flexible approach for studying change in individuals through time as a random effect and does not require all patients to have data at all measured points Our principal model of analysis includes treatment placebo or glycine as between subject factor and time as within subject factor Compliance will be also included as a time varying independent variable This project continues to recruit subjects
RESEARCH PLAN An abnormality of the glutamate neurotransmitter system has been hypothesized for both alcoholism and schizophrenia Studies suggest that the amino acid glycine may improve alcohol dependency and symptoms of schizophrenia by acting on the N methyl D aspartate NMDA glutamate receptor Glycine causes reversal of the effects of ethanol in animal studies and improves mood social withdrawal and other so called negative symptoms of schizophrenia Consequently the use of glycine by patients with schizophrenia and alcohol dependency may potentially decrease alcohol craving and alcohol consumption and also improve certain symptoms of schizophrenia The potential of glycine to improve both alcohol dependency and negative symptoms could represent an important step in the improvement of the quality of life for patients with schizophrenia
METHODOLOGYFINDINGSRESULTS In order to test this hypothesis we will use a double blind placebo controlled study and measure the number of drinks the degree of craving for alcohol and symptoms of schizophrenia among other parameters Our principal approach to analyses of medication effectiveness will be the application of the linear mixed effect model The linear mixed effect model permits a flexible approach for studying change in individuals through time as a random effect and does not require all patients to have data at all measured points Our principal model of analysis includes treatment placebo or glycine as between subject factor and time as within subject factor Compliance will be also included as a time varying independent variable This project continues to recruit subjects
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