Clozapine IM and Aggression in Schizophrenic Patients

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Vladimir Lerner, Beersheva Mental Health Center
ClinicalTrials.gov Identifier:
NCT00189995
First received: September 11, 2005
Last updated: July 23, 2013
Last verified: October 2005
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Intramuscular Clozapine in the Management of Aggression in Schizophrenic Patients

Resource links provided by NLM:


Further study details as provided by Beersheva Mental Health Center:

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

Enrollment: 0
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Vladimir Lerner, Associated Professor, Beersheva Mental Health Center
ClinicalTrials.gov Identifier: NCT00189995     History of Changes
Other Study ID Numbers: BMHC-4000
Study First Received: September 11, 2005
Last Updated: July 23, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

Additional relevant MeSH terms:
Aggression
Schizophrenia
Behavioral Symptoms
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Clozapine
Haloperidol
Haloperidol decanoate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
GABA Antagonists
GABA Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents
Anti-Dyskinesia Agents

ClinicalTrials.gov processed this record on July 26, 2014