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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR CLOZAPINE

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Clinical Trials for Clozapine

Trial ID Title Status Sponsor Phase Summary
NCT00000372 Glycine and D-Cycloserine in Schizophrenia Withdrawn Massachusetts General Hospital Phase 3 The purpose of this study is to compare the effects of D-cycloserine and glycine for treating negative symptoms (such as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.
NCT00001656 Comparison of Clozapine vs Olanzapine in Childhood-Onset Psychotic Disorders Completed National Institute of Mental Health (NIMH) Phase 4 The purpose of this study is to compare the effectiveness and side effects of the drugs clozapine and olanzapine in children and adolescents with schizophrenia and psychoses. Childhood psychosis is a serious disorder that may have devastating consequences. Effective treatments for the condition are under continual investigation. This study will examine the causes of and offer treatment for childhood psychosis. Participants in this study will undergo psychological tests, blood and urine tests, electroencephalogram (EEG), electrocardiogram (EKG), and magnetic resonance imaging (MRI) scans of the brain for the first 1 to 2 weeks of the study while taking their regular medications. Participants will then be tapered off their medications over 1 to 3 weeks and will continue to stay off medications for an additional 2 days to 3 weeks. During this time, participants will undergo psychiatric, neurological, and cardiac examinations as well as blood tests. After this period without medications, participants will be randomly assigned to receive either clozapine or olanzapine for 8 weeks. An EEG will be performed prior to treatment and after 6 weeks of study medication. Participants who respond well to the study drugs may continue to receive them through their own physician. Participants who do not respond to either clozapine or olanzapine or cannot tolerate their side effects will be treated individually with other drugs until optimum treatment is identified. Regular telephone updates and in person visits to NIH for repeat testing and MRIs will be conducted.
NCT00004826 Study of Clozapine for the Treatment of Psychosis in Patients With Idiopathic Parkinson's Disease Completed Memorial Hospital of Rhode Island N/A OBJECTIVES: I. Determine the efficacy and tolerability of clozapine in ameliorating psychosis in patients with idiopathic Parkinson's disease (PD). II. Determine the adverse effects of clozapine on motor function in this patient population. III. Determine the safety of clozapine in psychotic PD patients taking multiple anti-PD medications. IV. Describe the phenomenology of drug induced psychosis in PD.
NCT00014001 CATIE- Schizophrenia Trial Completed National Institute of Mental Health (NIMH) Phase 4 The CATIE Schizophrenia Trial is part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Project. The schizophrenia trial is being conducted to determine the long-term effects and usefulness of antipsychotic medications in persons with schizophrenia. It is designed for people with schizophrenia who may benefit from a medication change. The study involves the newer atypical antipsychotics (olanzapine, quetiapine, risperidone, clozapine, and ziprasidone)and the typical antipsychotics (perphenazine and fluphenazine decanoate). All participants will receive an initial comprehensive medical and psychiatric evaluation and will be closely followed throughout the study. For most participants the study will last up to 18 months. Everyone in the study will be offered an educational program about schizophrenia and family members will be encouraged to participate.
NCT00029458 Clozapine for Treatment-Resistant Mania Completed National Institute of Mental Health (NIMH) Phase 2 The purpose of this study is to evaluate the safety and effectiveness of clozapine as a treatment for the manic phase of bipolar disorder. A significant proportion of manic patients either do not respond adequately to conventional treatment or cannot tolerate the adverse effects associated with therapeutic doses of these agents. Clozapine may be a safe and effective treatment for mania. However, the efficacy of clozapine as an alternative therapy in treatment-resistant bipolar disorder mania has not been extensively researched. The study will be conducted in three phases. Phase 1 is a screening phase that will take place for 2 to 7 days. Participants will undergo a baseline positron emission tomography (PET) scan of the brain at the end of this period. In Phase 2, participants will be randomly assigned to receive either clozapine or placebo (an inactive pill) for 3 weeks. They may also receive lorazepam for the first 10 days of Phase 2. After 3 weeks, patients treated with clozapine will undergo a second PET scan. During Phase 3, participants who received placebo and did not improve will be offered clozapine for 3 weeks. Those who received clozapine and did not improve will receive other treatment for 3 weeks. At the end of Phase 3, participants who were treated with clozapine will have another PET scan.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Clozapine

Condition Name

Condition Name for Clozapine
Intervention Trials
Schizophrenia 112
Schizoaffective Disorder 28
Bipolar Disorder 9
Psychotic Disorders 7
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Condition MeSH

Condition MeSH for Clozapine
Intervention Trials
Schizophrenia 122
Psychotic Disorders 42
Disease 19
Mental Disorders 16
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Clinical Trial Locations for Clozapine

Trials by Country

Trials by Country for Clozapine
Location Trials
United States 164
Canada 14
Spain 11
Taiwan 10
Israel 9
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Trials by US State

Trials by US State for Clozapine
Location Trials
Massachusetts 21
New York 18
Maryland 14
California 12
Missouri 11
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Clinical Trial Progress for Clozapine

Clinical Trial Phase

Clinical Trial Phase for Clozapine
Clinical Trial Phase Trials
Phase 4 70
Phase 3 13
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for Clozapine
Clinical Trial Phase Trials
Completed 97
Recruiting 19
Terminated 9
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Clinical Trial Sponsors for Clozapine

Sponsor Name

Sponsor Name for Clozapine
Sponsor Trials
National Institute of Mental Health (NIMH) 18
Dartmouth-Hitchcock Medical Center 10
University of Maryland 9
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Sponsor Type

Sponsor Type for Clozapine
Sponsor Trials
Other 248
Industry 44
NIH 26
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