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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR CYCLOSERINE

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Clinical Trials for Cycloserine

Trial ID Title Status Sponsor Phase Summary
NCT00000194 Neurobiology of Opioid Dependence: 3 - 3 Withdrawn National Institute on Drug Abuse (NIDA) Phase 2 The purpose of this study is to study the effects of cycloserine on naloxone-precipitated opiate withdrawal.
NCT00000194 Neurobiology of Opioid Dependence: 3 - 3 Withdrawn Yale University Phase 2 The purpose of this study is to study the effects of cycloserine on naloxone-precipitated opiate withdrawal.
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.
NCT00000796 A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDRT Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per 9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain. Among TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion.
NCT00125528 D-cycloserine in the Management of Chronic Low Back Pain Completed Thomas J. Schnitzer Phase 2 Pre-clinical studies in rats suggest that D-cycloserine (DCS) is effective in the management of chronic neuropathic pain. This pilot study will attempt to determine the effect of D-cycloserine in the treatment of chronic low back pain. Other aims of this study are to determine the safety of D-cycloserine in the treatment of chronic low back pain and to determine which pain measurement scales are best at measuring the efficacy of treatment.
NCT00126282 A Medication Trial Combined With Behavior Therapy for Individuals With Obsessive-compulsive Disorder Completed Massachusetts General Hospital N/A This study examines the efficacy of the medication D-Cycloserine in the reduction of obsessions and compulsions in individuals with obsessive-compulsive disorder (OCD). All study participants will receive Exposure and Response Prevention, a common form of behavior therapy for individuals with OCD. Half (50%) of the participants will be randomly assigned to the placebo condition and the other half (50%) will be randomly assigned to receive D-Cycloserine. Because all participants will receive 10 sessions of behavior therapy, all participants are expected to improve from this treatment.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Cycloserine

Condition Name

Condition Name for Cycloserine
Intervention Trials
Schizophrenia 12
Obsessive-compulsive Disorder 8
Suicidal Ideation 4
Bipolar Depression 4
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Condition MeSH

Condition MeSH for Cycloserine
Intervention Trials
Disease 18
Schizophrenia 12
Depression 11
Compulsive Personality Disorder 11
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Clinical Trial Locations for Cycloserine

Trials by Country

Trials by Country for Cycloserine
Location Trials
United States 98
China 8
Germany 5
Canada 5
Israel 4
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Trials by US State

Trials by US State for Cycloserine
Location Trials
Massachusetts 23
New York 14
Connecticut 8
Illinois 7
California 6
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Clinical Trial Progress for Cycloserine

Clinical Trial Phase

Clinical Trial Phase for Cycloserine
Clinical Trial Phase Trials
Phase 4 13
Phase 3 16
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for Cycloserine
Clinical Trial Phase Trials
Completed 50
Recruiting 25
Unknown status 12
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Clinical Trial Sponsors for Cycloserine

Sponsor Name

Sponsor Name for Cycloserine
Sponsor Trials
Massachusetts General Hospital 15
National Institute of Mental Health (NIMH) 15
Boston University 8
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Sponsor Type

Sponsor Type for Cycloserine
Sponsor Trials
Other 152
NIH 28
U.S. Fed 11
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Johnson and Johnson
Colorcon

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