Status:
WITHDRAWN
Clozapine IM and Aggression in Schizophrenic Patients
Lead Sponsor:
Beersheva Mental Health Center
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 schizoph...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00189995
Last Update
July 24 2013
Active Locations (2)
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1
Beersheva Mental Health Center
Beersheva, Israel
2
Nes Ziona Medical Center
Ness Ziona, Israel