Facilitation of NMDA Receptor Function in Patients With Schizophrenia and Co-morbid Alcoholism
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2003
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 15, 2006
CompletedFirst Posted
Study publicly available on registry
June 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedResults Posted
Study results publicly available
April 12, 2017
CompletedJanuary 17, 2018
January 1, 2018
12.5 years
June 15, 2006
February 28, 2017
January 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Self Reported Weekly Alcohol Consumption
Percentage of drinking days and heavy drinking days using timeline follow back
12 weeks
Self Reported Weekly Alcohol Craving
The Obsessive Compulsive Drinking Scale (OCDS) is consisted by 14 items rated 0 - 4. The minimum and maximum values possibly obtained in this scale are respectively 0 and 56, this last one, meaning the most craving possible experienced. It is a short and easy to administer scale (average of 5 minutes per self-rating), built to measure severity and improvement during alcoholism treatment trials.
12 weeks
Weekly Ratings of Negative/Positive Psychotic Symptoms
The PANSS or the Positive and Negative Syndrome Scale is a medical scale used for measuring symptom severity of patients with schizophrenia. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. Of the 30 items included in the PANSS, 7 constitute a Positive Scale, 7 a Negative Scale, and the remaining 16 a General Psychopathology Scale.The scores for these scales are arrived at by summation of ratings across component items. Therefore, the potential ranges are 7 to 49 for the Positive and Negative Scales, and 16 to 112 for the General Psychopathology Scale. A higher score indicates more severe symptoms for each scale.
12 weeks
Baseline and End of Treatment Cognitive Functioning Measures (Hopkins)
Hopkins Verbal Learning Test Assesses short term verbal learning and memory. Subscales include immediate recall (0-36), delayed recall (0-12) , and recognition (0-12). A higher score indicates better memory performance.
12 weeks
Secondary Outcomes (3)
Weekly Drug Use
12 weeks
Baseline and End of Treatment Quality of Life
12 weeks
Baseline and End of Treatment Neurophysiological Measures
12 weeks
Study Arms (2)
Glycine
EXPERIMENTALGlycine, 0.8 gr per kg given in two daily doses
placebo
PLACEBO COMPARATORplacebo will be administered.
Interventions
Eligibility Criteria
You may qualify if:
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- DSM-IV diagnosis of alcohol dependence
- Stable treatment with typical or atypical antipsychotics
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Stanley Medical Research Institutecollaborator
Study Sites (1)
VA Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elizabeth Ralevski Assistant Professor of Psychiatry
- Organization
- Yale University
Study Officials
- PRINCIPAL INVESTIGATOR
Ismene Petrakis, M.D.
Yale University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2006
First Posted
June 20, 2006
Study Start
June 1, 2003
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
January 17, 2018
Results First Posted
April 12, 2017
Record last verified: 2018-01