Clozapine and Olanzapine Treatment of Aggression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-06-30

Study Completion Date

2004-07-31

Brief Summary

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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.

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Detailed Description

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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

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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clozapine

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;

Group Type EXPERIMENTAL

Clozapine

Intervention Type DRUG

500 mg/day

Olanzapine

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

Group Type EXPERIMENTAL

Olanzapine

Intervention Type DRUG

20 mg/day

Haloperidol

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

Group Type ACTIVE_COMPARATOR

Haloperidol

Intervention Type DRUG

20 mg/day

Interventions

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Clozapine

500 mg/day

Intervention Type DRUG

Olanzapine

20 mg/day

Intervention Type DRUG

Haloperidol

20 mg/day

Intervention Type DRUG

Other Intervention Names

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clozaryl zyprexa Haldol

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No