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Clozapine IM and Aggression in Schizophrenic Patients

This study is not yet open for participant recruitment.
Verified by Beersheva Mental Health Center, October 2005

Sponsored by: Beersheva Mental Health Center
Information provided by: Beersheva Mental Health Center
ClinicalTrials.gov Identifier: NCT00189995
  Purpose

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
Schizophrenia
Drug: clozapine
Drug: haloperidol
Phase III

MedlinePlus related topics:   Schizophrenia   

Drug Information available for:   Clozapine    Haloperidol    Haloperidol decanoate   

U.S. FDA Resources

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

Further study details as provided by Beersheva Mental Health Center:

Primary Outcome Measures:
  • Positive and Negative Syndrome Scale
  • Overt Aggression Scale

Estimated Enrollment:   20

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • schizophrenic, schizoaffective, or schizophreniform according to DSM-IV
  • treatment-resistant
  • presenting pathologic violent-aggressive behavior on admission
  • at risk for self damage
  • age: 18-65
  • patient is not participating in any other study at time of this study
  • minimal score of 70 on PANSS
  • prior resistance to at least 2 different classes of neuroleptics
  • OAS scores of at least 4 points in physical aggression sections and at least 2 points in verbal aggression section

Exclusion Criteria:

  • neutropenia or any other abnormal CBC result
  • myeloproliferative disease
  • chronic physical diseases such as liver, renal or cardiac diseases
  • history of alcohol or drug abuse
  • history of drug induced granulocytopenia/agranulocytosis
  • alcoholic/drug psychosis or intoxication
  • carbamazepine or other bone marrow suppressor treatment
  • uncontrolled epilepsy
  • paralytic ileus
  • hypersensitivity to clozapine
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189995

Contacts
Contact: Vladimir Lerner, MD, PhD     9728-6401-408     lernervld@yahoo.com    
Contact: Baruch Spivak, MD     9728-938-4053     spivakb@post.tau.ac.il    

Locations
Israel
Beersheva Mental Health Center    
      Beersheva, Israel
Nes Ziona Medical Center    
      Nes Ziona, Israel

Sponsors and Collaborators
Beersheva Mental Health Center

Investigators
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    
  More Information


Study ID Numbers:   BMHC-4000
First Received:   September 11, 2005
Last Updated:   August 22, 2007
ClinicalTrials.gov Identifier:   NCT00189995
Health Authority:   Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Beersheva Mental Health Center:
schizophrenia  
aggression  
clozapine  
efficacy  
double-blind  

Study placed in the following topic categories:
Haloperidol
Schizophrenia
Haloperidol decanoate
Dopamine
Mental Disorders
Clozapine
Psychotic Disorders
Aggression
Serotonin
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Antiemetics
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
GABA Antagonists
Serotonin Antagonists
Serotonin Agents
Autonomic Agents
Therapeutic Uses
GABA Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on December 10, 2008




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