Trials / Completed
CompletedNCT01123408
Clozapine and Olanzapine Treatment of Aggression
Clozapine and Olanzapine in the Treatment of Violence in Schizophrenic Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 110 (actual)
- Sponsor
- Nathan Kline Institute for Psychiatric Research · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Clozapine | 500 mg/day |
| DRUG | Olanzapine | 20 mg/day |
| DRUG | Haloperidol | 20 mg/day |
Timeline
- Start date
- 1999-06-01
- Primary completion
- 2004-07-01
- Completion
- 2004-07-01
- First posted
- 2010-05-14
- Last updated
- 2010-05-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01123408. Inclusion in this directory is not an endorsement.