Clozapine and Olanzapine Treatment of Aggression

• Status: Completed
• Trial end date: 2004-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nathan Kline Institute for Psychiatric Research
• Treatments: Clozapine; Haloperidol; Haloperidol decanoate; Olanzapine

Criteria

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.