Phase 2
Completed N=20
Facilitation of NMDA Receptor Function in Patients With Schizophrenia and Co-morbid Alcoholism
Alcoholism · Schizophrenia
Source: ClinicalTrials.gov NCT00338598 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: Self Reported Weekly Alcohol Consumption — 23.4; 19.6; 15.7; 10.0 percentage of days
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self Reported Weekly Alcohol Consumption |
23.4; 19.6; 15.7; 10.0 | — |
| PRIMARY Self Reported Weekly Alcohol Craving |
16.1; 17.5; 10.2; 12.1 | — |
| PRIMARY Weekly Ratings of Negative/Positive Psychotic Symptoms |
16.3; 15.3; 12.0; 13.5; 16.7; 12.5 | — |
| PRIMARY Baseline and End of Treatment Cognitive Functioning Measures (Hopkins) |
21.8; 19.7; 20.9; 19.5; 6.1; 6.4 | — |
| SECONDARY Weekly Drug Use |
— | — |
| SECONDARY Baseline and End of Treatment Quality of Life |
— | — |
| SECONDARY Baseline and End of Treatment Neurophysiological Measures |
— | — |
Eligibility Criteria
Inclusion Criteria
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- DSM-IV diagnosis of alcohol dependence
- Stable treatment with typical or atypical antipsychotics
Exclusion Criteria
- Axis I diagnosis other than alcohol dependence, schizophrenia, schizoaffective disorder, OCD, and PTSD.
- current drug dependence
- evidence of significant hepatocellular injury evidence by abnormal SGOT or SGPT levels
- history of seizures
- diabetes and medical conditions that would alter glycine metabolism
- positive pregnancy test
- treatment with clozapine, naltrexone or disulfiram
Data sourced from ClinicalTrials.gov (NCT00338598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.