Clozapine and Olanzapine Treatment of Aggression

Schizophrenia Clinical Trial

Official title:

Clozapine and Olanzapine in the Treatment of Violence in Schizophrenic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123408
• Other study ID #: 2244
• Status: Completed
• Phase: N/A
• First received: May 12, 2010
• Last updated: May 13, 2010
• Start date: June 1999
• Est. completion date: July 2004

Study information

• Verified date: May 2010
• Source: Nathan Kline Institute for Psychiatric Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This was a double-blind randomized study with three treatment arms: clozapine, olanzapine and haloperidol. We compared these three medications in the treatment of aggressive behavior over a 12 week period.

Description:

Objective: The purpose of our study was the investigation of the effect of atypical antipsychotic agents on interpersonal violence and aggression.

We compared the efficacy of two atypical antipsychotic agents, clozapine and olanzapine with one another and with haloperidol in the treatment of physical assaults and other assaultive behaviors in physically assaultive patients with schizophrenia and schizoaffective disorder.

Method: The subjects were 110 physically assaultive inpatients diagnosed with schizophrenia or schizoaffective disorder.

They were randomly assigned to treatment with clozapine (N=37), olanzapine (N=37) or haloperidol (N=36) in a 12-week, double-blind trial. Incidents of overt aggression were recorded and their severity was scored with the Modified Overt Aggression Scale (MOAS). Psychiatric symptoms were assessed through the Positive and Negative Syndrome Scale (PANSS). We also assessed various side effects and monitored vital signs and drew bloods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2004
• Est. primary completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age: 18 to 60 years.

• Diagnosis of schizophrenia or schizoaffective disorder.

• Aggression: One episode of physical assault directed at another person in the hospital and persistence of violence/hostility for two weeks, as evidenced by the presence of some other physical, verbal or property assault or hostility, which would result in a score of 4 or more on the Positive and Negative Syndrome Scale (PANSS) Hostility Item.

Exclusion Criteria:

• Patients who were hospitalized for more than a year

• Patients who had a history of nonresponse to clozapine, olanzapine or haloperidol (defined as a lack of improvement despite a contiguous adequate trial of medication)

• Patients who had a history of clozapine, olanzapine, or haloperidol intolerance

• Patients who had medical conditions that would be adversely affected by any of these three medications.

• Patients who received a depot antipsychotic within 30 days before randomization.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Clozapine
500 mg/day
• Olanzapine
20 mg/day
• Haloperidol
20 mg/day

Locations

Country	Name	City	State
United States	Nathan Kline Institute	Orangeburg	New York

Sponsors (1)

Lead Sponsor	Collaborator
Nathan Kline Institute for Psychiatric Research

Country where clinical trial is conducted

United States, 

References & Publications (2)

Krakowski MI, Czobor P, Citrome L, Bark N, Cooper TB. Atypical antipsychotic agents in the treatment of violent patients with schizophrenia and schizoaffective disorder. Arch Gen Psychiatry. 2006 Jun;63(6):622-9. — View Citation

Krakowski MI, Czobor P, Nolan KA. Atypical antipsychotics, neurocognitive deficits, and aggression in schizophrenic patients. J Clin Psychopharmacol. 2008 Oct;28(5):485-93. doi: 10.1097/JCP.0b013e3181855cd6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of aggressive incidents	The Modified Overt Aggression scale (MOAS) was used to record all aggressive incidents. The primary measure was the total score on the MOAS as well as the score on the MOAS physical aggression subscale	12 weeks	No
Secondary	Psychiatric Symptoms	Psychiatric symptoms were assessed with the Positive and Negative Syndrome Scale (PANSS) weekly for the first 4 weeks and then bi-weekly for the remainder of the study	12 weeks	No
Secondary	Side effects of medications	The side effects of the medications were measured with the ESRS on a weekly basis for the duration of the study	12 weeks	Yes