Clozapine and Olanzapine Treatment of Aggression

Nathan Kline Institute for Psychiatric Research

Status: Completed

Conditions: Schizophrenia

Treatments: Drug: Olanzapine; Drug: Clozapine; Drug: Haloperidol

Study type: Interventional

Funder types: Other

Identifiers

NCT01123408

2244

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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110 participants in 3 patient groups

clozapine

Experimental group

Description:

During the first 6 weeks clozapine was gradually increased to 500 mg/day and then continued. For the next period, it could vary from 200-800 mg/day;

Treatment:

Drug: Clozapine

Olanzapine

Experimental group

Description:

During the first 6 weeks olanzapine was increased to 20 mg and remained fixed for until the end of six week. During the last 6 weeks olanzapine could vary from 10 to 30 mg/day

Treatment:

Drug: Olanzapine

Haloperidol

Active Comparator group

Description:

During the first 6 weeks haloperidol was increased to 20 mg and remained fixed for until the end of six week. During the last 6 weeks the dose could vary from 10 to 30 mg/day

Treatment:

Drug: Haloperidol