Clinical Trials Directory

Trials / Completed

CompletedNCT01123408

Clozapine and Olanzapine Treatment of Aggression

Clozapine and Olanzapine in the Treatment of Violence in Schizophrenic Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
110 (actual)
Sponsor
Nathan Kline Institute for Psychiatric Research · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
DRUGClozapine500 mg/day
DRUGOlanzapine20 mg/day
DRUGHaloperidol20 mg/day

Timeline

Start date
1999-06-01
Primary completion
2004-07-01
Completion
2004-07-01
First posted
2010-05-14
Last updated
2010-05-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01123408. Inclusion in this directory is not an endorsement.