Clozapine and Olanzapine Treatment of Aggression
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Clozapine and Olanzapine in the Treatment of Violence in Schizophrenic Patients|
- Number of aggressive incidents [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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
- Psychiatric Symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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
- Side effects of medications [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]The side effects of the medications were measured with the ESRS on a weekly basis for the duration of the study
|Study Start Date:||June 1999|
|Study Completion Date:||July 2004|
|Primary Completion Date:||July 2004 (Final data collection date for primary outcome measure)|
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;
Other Name: clozaryl
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
Other Name: zyprexa
Active Comparator: 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
Other Name: Haldol
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01123408
|United States, New York|
|Nathan Kline Institute|
|Orangeburg, New York, United States, 10962|
|Study Director:||Bennett L Leventhal, MD||Nathan Kline Institute|