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Generated: December 18, 2018

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CLINICAL TRIALS PROFILE FOR GLYCINE 1.5% IN PLASTIC CONTAINER

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Clinical Trials for Glycine 1.5% In Plastic Container

Trial ID Title Status Sponsor Phase Summary
NCT00000371 Trial of D-Cycloserine in Schizophrenia Completed Massachusetts General Hospital Phase 3 To characterize further the effects of D-cycloserine augmentation of antipsychotic treatment on negative symptoms, performance on neurocognitive tasks, and on markers for glutamatergic, dopaminergic and serotonergic function in serum and cerebrospinal fluid. To determine if negative symptoms and cognitive function improve over time, if these improvements meaningfully impact quality of life factors, if they correlate with markers of neuronal function, and if subpopulations can be identified according to response. Dysfunction of glutamatergic neuronal systems has recently been implicated in the pathophysiology of schizophrenia based on the finding that non-competitive inhibitors of the NMDA receptor can reproduce in normals the positive symptoms, negative symptoms, and cognitive deficits of schizophrenia. Furthermore, glutamatergic dysfunction may alter forebrain dopaminergic neuronal activity, a system central to the antipsychotic action of typical neuroleptics. It is believed that enhancing NMDA receptor function by systemic treatment with D-cycloserine, a partial agonist at the glycine modulatory site of the NMDA receptor, will reduce symptoms in schizophrenia. Sixty schizophrenic outpatients with prominent, primary negative symptoms are treated with antipsychotic medication and are randomly assigned to D-cycloserine or placebo for a 6-month, fixed-dose trial. The primary outcome measure is the total score on the Scale for Assessment of Negative Symptoms (SANS). A neuropsychological battery, which emphasizes tests sensitive to prefrontal cortical function, is administered. Blood is obtained at several time points and CSF is obtained at Week 8 for assay of concentrations of D-cycloserine, glutamate, HVA, and 5HIAA.
NCT00000372 Glycine and D-Cycloserine in Schizophrenia Withdrawn Massachusetts General Hospital Phase 3 The purpose of this study is to compare the effects of D-cycloserine and glycine for treating negative symptoms (such as loss of interest, loss of energy, loss of warmth, and loss of humor) which occur between phases of positive symptoms (marked by hallucinations, delusions, and thought confusions) in schizophrenics. Clozapine is currently the most effective treatment for negative symptoms of schizophrenia. Two other drugs, D-cycloserine and glycine, are being investigated as new treatments. D-cycloserine improves negative symptoms when added to some drugs, but may worsen these symptoms when given with clozapine. Glycine also improves negative symptoms and may still be able to improve these symptoms when given with clozapine. This study gives either D-cycloserine or glycine (or an inactive placebo) with clozapine to determine which is the best combination. Patients will be assigned to 1 of 3 groups. Group 1 will receive D-cycloserine plus clozapine. Group 2 will receive glycine plus clozapine. Group 3 will receive an inactive placebo plus clozapine. Patients will receive these medications for 8 weeks. Negative symptoms of schizophrenia will be monitored through the Scale for the Assessment of Negative Symptoms, Positive symptoms will be monitored through the Positive and Negative Syndrome Scale, and additionally subjects will complete the Brief Psychiatric Rating Scale and the Global Assessment Scale. An individual may be eligible for this study if he/she is 18 to 65 years old and has been diagnosed with schizophrenia.
NCT00005658 Glycine to Treat Psychotic Disorders in Children Completed National Institute of Mental Health (NIMH) Phase 2 This study will test the safety and effectiveness of the amino acid glycine in treating psychotic disorders in children. The drug will be given as an adjunct (in addition) to the patient's current antipsychotic medication. Children age nine to 18 with schizophrenia or schizoaffective disorder whose symptoms began before age 13 may be eligible for this 10-week study. Patients will be hospitalized during the course of the trial. Weekend visits home may be permitted. Children enrolled in the study will be evaluated during a two-week pre-treatment period with written tests for IQ and academic functioning and with a magnetic resonance imaging (MRI) scan of the brain. For the MRI, the child lies on a table that slides into a large donut-shaped machine with a strong magnetic field. This procedure produces images of the brain that may help identify brain abnormalities in schizophrenia that develop in childhood. During the eight-week treatment phase, patients will receive glycine powder dissolved in water once a day, in addition to their other antipsychotic medications. They will undergo the following additional procedures during the course of treatment: 1. Comprehensive psychiatric examination 2. Blood pressure and pulse monitoring once a week 3. Blood tests every other week - About one ounce of blood is drawn per week to measure glycine levels 4. Eye movement study at week eight - Using a technique called infrared oculography, special detectors measure infrared light reflected off the child's eyes while he or she watches a moving square on a video monitor. 5. Lumbar puncture (spinal tap) once during the study - About one-half ounce of cerebrospinal fluid (the fluid surrounding the brain and spinal cord) is withdrawn through a needle placed in the lower part of the spine for analysis of brain chemicals. Patients who respond well may continue to receive glycine treatment through their referring physician after the study is completed. NIMH will follow patients by phone every six months and with visits at two-year intervals.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Glycine 1.5% In Plastic Container

Condition Name

Condition Name for Glycine 1.5% In Plastic Container
Intervention Trials
Schizophrenia 22
Psychoses 4
Psychotic Disorders 4
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Condition MeSH

Condition MeSH for Glycine 1.5% In Plastic Container
Intervention Trials
Schizophrenia 27
Psychotic Disorders 11
Disease 10
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Clinical Trial Locations for Glycine 1.5% In Plastic Container

Trials by Country

Trials by Country for Glycine 1.5% In Plastic Container
Location Trials
United States 66
Italy 13
China 10
Taiwan 9
Israel 7
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Trials by US State

Trials by US State for Glycine 1.5% In Plastic Container
Location Trials
Massachusetts 9
Maryland 9
New York 8
California 7
Connecticut 4
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Clinical Trial Progress for Glycine 1.5% In Plastic Container

Clinical Trial Phase

Clinical Trial Phase for Glycine 1.5% In Plastic Container
Clinical Trial Phase Trials
Phase 4 11
Phase 3 11
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Glycine 1.5% In Plastic Container
Clinical Trial Phase Trials
Completed 49
Recruiting 14
Unknown status 13
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Clinical Trial Sponsors for Glycine 1.5% In Plastic Container

Sponsor Name

Sponsor Name for Glycine 1.5% In Plastic Container
Sponsor Trials
China Medical University Hospital 8
Peking Union Medical College Hospital 7
Herzog Hospital 5
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Sponsor Type

Sponsor Type for Glycine 1.5% In Plastic Container
Sponsor Trials
Other 124
Industry 27
NIH 20
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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Healthtrust
Mallinckrodt
Cerilliant
Boehringer Ingelheim
Fish and Richardson
Colorcon
Dow
Fuji

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