Clozapine IM and Aggression in Schizophrenic Patients

Sponsor

Beersheva Mental Health Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00189995

Collaborator

(none)

Enrollment

Locations

Patients Per Site

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: clozapine Drug: haloperidol	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

Intramuscular Clozapine in the Management of Aggression in Schizophrenic Patients

Outcome Measures

Primary Outcome Measures

Positive and Negative Syndrome Scale []
Overt Aggression Scale []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Beersheva Mental Health Center	Beersheva		Israel
2	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