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Sponsored by: |
Beersheva Mental Health Center |
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Information provided by: | Beersheva Mental Health Center |
ClinicalTrials.gov Identifier: | NCT00189995 |
Aggressive, persistent aggression and impulsive behavior are frequently observed in schizophrenic patients. According to some researchers "more than 50% of all psychiatric patients and 10% of schizophrenic patients show aggressive symptoms varying from threatening behavior and agitation to assault"(1). It is a common cause of psychiatric admission and is a therapeutic issue. The treatment of these symptoms is a clinical problem for both patients and staff. Violent behavior, a major detrimental factor in stigmatization of the mentally ill, also poses physical danger for the patients themselves. Current pharmacotherapy of pathologic aggression involves the use of multiple agents (typical and atypical antipsychotics, benzodiazepines, mood stabilizers, beta-blockers, antiandrogenic hormones, and selective serotonin reuptake inhibitors) on empiric basis, with varying degrees of response (2-6). Unfortunately, these approaches lead to numerous side effects. Poor or noncompliance with pharmacotherapy makes it difficult to choose the appropriate preparation. Currently, typical neuroleptics are still the first choice in treating acute aggressive symptoms, while risperidone and olanzapine could be alternatives (5-7). Typical depot neuroleptics should be considered in cases where medication compliance is a problem. Most clinical information on treating of aggression has been collected about atypical neuroleptics, particularly regarding clozapine.
Clozapine is indicated in psychotic state and/or in drug-resistant schizophrenic patients. According to the FDA - it is the drug of choice in suicidal and aggressive patients, due-to psychotic state. It was found helpful in nearly 30% of resistant schizophrenic patients. Concerning the parenteral administration of clozapine - very little data is available today. This study aims to investigate efficacy and safety (psychopathology, and side effects) of parenteral clozapine in treatment of aggressive behavior in schizophrenic patients in a double-blind trial.
Condition | Intervention | Phase |
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Schizophrenia |
Drug: clozapine Drug: haloperidol |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | Intramuscular Clozapine in the Management of Aggression in Schizophrenic Patients |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Vladimir Lerner, MD, PhD | 9728-6401-408 | lernervld@yahoo.com |
Contact: Baruch Spivak, MD | 9728-938-4053 | spivakb@post.tau.ac.il |
Israel | |
Beersheva Mental Health Center | |
Beersheva, Israel | |
Nes Ziona Medical Center | |
Nes Ziona, Israel |
Principal Investigator: | Valdimir Lerner, MD, PhD | Ben-Gurion University of the Negev |
Principal Investigator: | Baruch Spivak, MD | Tel Aviv University |
Principal Investigator: | Chanoch Midownik, MD | Ben-Gurion University of the Negev |
Study ID Numbers: | BMHC-4000 |
Study First Received: | September 11, 2005 |
Last Updated: | August 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00189995 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
schizophrenia aggression clozapine efficacy double-blind |
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants Antipsychotic Agents Serotonin Behavioral Symptoms Schizophrenia Haloperidol |
Haloperidol decanoate Dopamine Mental Disorders Clozapine Dopamine Agents Psychotic Disorders Peripheral Nervous System Agents Aggression Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiemetics Haloperidol Schizophrenia Serotonin Antagonists Mental Disorders Therapeutic Uses Aggression Schizophrenia and Disorders with Psychotic Features Tranquilizing Agents |
Gastrointestinal Agents Central Nervous System Depressants Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Behavioral Symptoms GABA Antagonists Serotonin Agents Autonomic Agents Clozapine GABA Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |