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Completed

NCT Number: NCT01123408

Clozapine and Olanzapine Treatment of Aggression

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nathan Kline Institute

Orangeburg, New York, 10962, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clozapine

Drug

500 mg/day

Other names: clozaryl

Olanzapine

Drug

20 mg/day

Other names: zyprexa

Haloperidol

Drug

20 mg/day

Other names: Haldol

Primary outcomes

  1. Number of aggressive incidents

    Time frame: 12 weeks

    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

Secondary outcomes

  1. Psychiatric Symptoms

    Time frame: 12 weeks

    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

  2. Side effects of medications

    Time frame: 12 weeks

    The side effects of the medications were measured with the ESRS on a weekly basis for the duration of the study

Sponsors and collaborators

Lead sponsor

Nathan Kline Institute for Psychiatric Research

Other

Registry information

Official study title

Clozapine and Olanzapine in the Treatment of Violence in Schizophrenic Patients

Important dates

Study start
1999
Primary completion
2004
Study completion
2004
First posted
May 14, 2010
Registry last updated
May 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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