Clozapine and Olanzapine Treatment of Aggression

NCT01123408 | Completed

• 1 other identifier: 2244
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Keywords

schizophrenia; aggression; clozapine; olanzapine

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks

Secondary Outcomes (2)

• Psychiatric Symptoms

  12 weeks

• Side effects of medications

  12 weeks

Study Arms (3)

clozapine

EXPERIMENTAL

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

Olanzapine

EXPERIMENTAL

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

Haloperidol

ACTIVE COMPARATOR

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

Interventions

Clozapine DRUG

500 mg/day

Also known as: clozaryl

clozapine

Olanzapine DRUG

20 mg/day

Also known as: zyprexa

Olanzapine

Haloperidol DRUG

20 mg/day

Also known as: Haldol

Haloperidol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nathan Kline Institute for Psychiatric Research: lead

Study Sites (1)

Nathan Kline Institute

Orangeburg, New York, 10962, United States

Location

Related Publications (5)

• Krakowski MI, Czobor P, Citrome L, Bark N, Cooper TB. Atypical antipsychotic agents in the treatment of violent patients with schizophrenia and schizoaffective disorder. Arch Gen Psychiatry. 2006 Jun;63(6):622-9. doi: 10.1001/archpsyc.63.6.622.

  PMID: 16754835 RESULT

• Krakowski MI, Czobor P, Nolan KA. Atypical antipsychotics, neurocognitive deficits, and aggression in schizophrenic patients. J Clin Psychopharmacol. 2008 Oct;28(5):485-93. doi: 10.1097/JCP.0b013e3181855cd6.

  PMID: 18794642 RESULT

• Ibragimov K, Keane GP, Carreno Glaria C, Cheng J, Llosa AE. Haloperidol (oral) versus olanzapine (oral) for people with schizophrenia and schizophrenia-spectrum disorders. Cochrane Database Syst Rev. 2024 Jul 3;7(7):CD013425. doi: 10.1002/14651858.CD013425.pub2.

  PMID: 38958149 DERIVED

• Krakowski M, Tural U, Czobor P. The Importance of Conduct Disorder in the Treatment of Violence in Schizophrenia: Efficacy of Clozapine Compared With Olanzapine and Haloperidol. Am J Psychiatry. 2021 Mar 1;178(3):266-274. doi: 10.1176/appi.ajp.2020.20010052. Epub 2021 Jan 21.

  PMID: 33472389 DERIVED

• Krakowski MI, Czobor P. Executive function predicts response to antiaggression treatment in schizophrenia: a randomized controlled trial. J Clin Psychiatry. 2012 Jan;73(1):74-80. doi: 10.4088/JCP.11m07238. Epub 2011 Nov 29.

  PMID: 22152404 DERIVED

MeSH Terms

Conditions

Schizophrenia; Aggression

Interventions

Clozapine; Olanzapine; Haloperidol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Social Behavior

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Butyrophenones; Ketones; Organic Chemicals

Study Officials

• Bennett L Leventhal, MD

  Nathan Kline Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 12, 2010
• First Posted: May 14, 2010
• Study Start: June 1, 1999
• Primary Completion: July 1, 2004
• Study Completion: July 1, 2004
• Last Updated: May 14, 2010

Record last verified: 2010-05

Locations

US (1)