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| Sponsor: | Elizabeth Ralevski |
|---|---|
| Collaborator: |
Stanley Medical Research Institute |
| Information provided by (Responsible Party): | Elizabeth Ralevski, Yale University |
| ClinicalTrials.gov Identifier: | NCT00338598 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alcoholism Schizophrenia |
Drug: Glycine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Facilitation of NMDA Receptor Function in Patients With Schizophrenia and Co-morbid Alcoholism |
| Estimated Enrollment: | 46 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
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.
METHODOLOGY/FINDINGS/RESULTS: 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.
Eligibility| Ages Eligible for Study: | 21 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Connecticut | |
| VA Connecticut Healthcare System | |
| West Haven, Connecticut, United States, 06516 | |
| Principal Investigator: | Ismene Petrakis, M.D. | Yale University |
More Information
| Responsible Party: | Elizabeth Ralevski, Assistant Professor, Yale University |
| ClinicalTrials.gov Identifier: | NCT00338598 History of Changes |
| Other Study ID Numbers: | HIC # 20915 |
| Study First Received: | June 15, 2006 |
| Last Updated: | January 26, 2012 |
| Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
|
glycine treatment alcohol dependence schizophrenia |
|
Alcoholism Schizophrenia Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Schizophrenia and Disorders with Psychotic Features |
Glycine Glycine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |