An interventional study of Clozapine and Olanzapine in Schizophrenia, sponsored by Nathan Kline Institute for Psychiatric Research. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2010-05-14.
Sponsored by Nathan Kline Institute for Psychiatric Research · Not applicable, Interventional, and Treatment
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.
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 110 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
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Exclusion Criteria:
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;
Drug: Clozapine
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
Drug: Olanzapine
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
Drug: Haloperidol
500 mg/day
Also known as: clozaryl
20 mg/day
Also known as: zyprexa
20 mg/day
Also known as: Haldol
Number of aggressive incidents
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
Time frame: 12 weeks
Psychiatric Symptoms
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
Time frame: 12 weeks
Side effects of medications
The side effects of the medications were measured with the ESRS on a weekly basis for the duration of the study
Time frame: 12 weeks
This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.
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Nathan Kline Institute for Psychiatric Research