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| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycine | Experimental | Glycine, 0.8 gr per kg given in two daily doses |
|
| placebo | Placebo Comparator | placebo will be administered. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycine | Drug | Glycine, 0.8 gr per kg given in two daily doses |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weekly Drug Use | 12 weeks | |
| Baseline and End of Treatment Quality of Life | 12 weeks | |
| Baseline and End of Treatment Neurophysiological Measures |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ismene Petrakis, M.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System | West Haven | Connecticut | 06516 | United States |
Twenty men, who met DSM IV criteria for schizophrenia or schizoaffective disorder, who also met DSM IV diagnosis of alcohol dependence with at least one recent episode of heavy drinking (defined as more than 5 drinks/drinking episode) over the past 14 days participated in the study. The participants were in stable treatment for at least 2 weeks.
Participants were recruited from the VA hospital in West Haven, CT and the Community Mental Health Center in New Haven, CT through word of mouth, advertisement and clinician referrals.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glycine | Glycine, 0.8 gr per kg given in two daily doses Glycine: Glycine, 0.8 gr per kg given in two daily doses |
| FG001 | Placebo | placebo will be administered. placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glycine | Glycine, 0.8 gr per kg given in two daily doses Glycine: Glycine, 0.8 gr per kg given in two daily doses |
| BG001 | Placebo | placebo will be administered. placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self Reported Weekly Alcohol Consumption | Percentage of drinking days and heavy drinking days using timeline follow back | Posted | Mean | Standard Error | percentage of days | 12 weeks |
|
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glycine | Glycine, 0.8 gr per kg given in two daily doses Glycine: Glycine, 0.8 gr per kg given in two daily doses |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER for intoxication | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Ralevski Assistant Professor of Psychiatry | Yale University | +1 203-932-5711 | 4282 | elizabeth.ralevski@yale.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005998 | Glycine |
| ID | Term |
|---|---|
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| placebo |
| Drug |
|
| 12 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Drinks per day | Mean | Standard Deviation | drinks per day |
|
| Participants |
|
|
| Primary | 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. | Posted | Mean | Standard Error | units on a scale | 12 weeks |
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | units on a scale | 12 weeks |
|
|
|
| Primary | 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. | Posted | Mean | Standard Error | units on a scale | 12 weeks |
|
|
|
| Secondary | Weekly Drug Use | Data was not collected | Posted | 12 weeks |
|
|
| Secondary | Baseline and End of Treatment Quality of Life | Data was not collected | Posted | 12 weeks |
|
|
| Secondary | Baseline and End of Treatment Neurophysiological Measures | Data was not collected | Posted | 12 weeks |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 3 |
| 10 |
| EG001 | Placebo | placebo will be administered. placebo | 0 | 10 | 0 | 10 | 2 | 10 |
| Chest Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| ER Visit | General disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Relapse | General disorders | Systematic Assessment |
|
| auditory hallucinations | Psychiatric disorders | Systematic Assessment |
|
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| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| Baseline Negative |
|
| Week 12 Negative |
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| Baseline General |
|
| Week 12 General |
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| Baseline Delayed Recall |
|
| 12 Weeks Delayed Recall |
|
| Baseline Recognition |
|
| 12 Weeks Recognition |
|