Intramuscular (IM) Olanzapine Versus IM Haloperidol Plus Lorazepam for Acute Agitation in Schizophrenia

NCT00797277 | Completed Phase 3 Results

• 1 other identifier: 950107
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to compare the efficacy and safety of intramuscular 10 mg olanzapine versus intramuscular 5 mg haloperidol plus lorazepam 2 mg in the treatment of acute agitated schizophrenic patients of Taiwanese populations.

Conditions

Schizophrenia; Schizoaffective Disorder; Agitation

Keywords

schizophrenia; schizoaffective disorder; olanzapine; haloperidol; lorazepam; agitation

Outcome Measures

Primary Outcomes (1)

• The Change of the Positive and Negative Symptom Scale Excited Component (PANSS-EC) Score From Baseline to 120 Minutes After First Injection

  The primary efficacy measure was PANSS-EC, which was derived from the PANSS by its originators using a principal-components factor analysis, and includes the items of tension, uncooperativeness, hostility, poor impulse control and excitement.22 The score of each item ranges from 1 (normal) to 7 (most severe), with a total sum score ranging from 5 to 35. The changes in PANSS-EC from baseline to 2 hours after the first injection were compared.

  from baseline to 120 minutes after first injection

Secondary Outcomes (1)

• Change of the Agitation-Calmness Evaluation Scale (ACES) Score From Baseline to 120 Minutes After 1st Injection

  from baseline to 120 minutes after first injection

Study Arms (2)

IM olanzapine

EXPERIMENTAL

Patients of this arm received 10 mg IM olanzapine after randomization

Drug: IM olanzapine

IM haloperidol plus lorazepam

ACTIVE COMPARATOR

Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization

Drug: IM haloperidol plus lorazepam

Interventions

IM olanzapine DRUG

10mg olanzapine IM

Also known as: zyprexa

IM olanzapine

IM haloperidol plus lorazepam DRUG

IM 5 mg haloperidol plus IM 2 mg lorazepam

Also known as: haldol and ativan

IM haloperidol plus lorazepam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and non-pregnant, non-lactating women aged 18 to 65 years with a primary diagnosis of schizophrenia (DSM-IV)
• were hospitalized due to an acute relapse
• were clinically agitated with a minimum total score of ≧ 14 on the five items of the PANSS-EC and at least one individual item score of ≧ 4 using the 1-7 scoring system prior to first IM injection of study drug.

You may not qualify if:

• female subjects who were either pregnant or breast-feeding;
• patients with acute, serious or unstable medical conditions;
• treatment with benzodiazepines within 4 hours prior to the first IM study drug administration;
• treatment with an injection depot neuroleptic within 1 injection interval prior to study drug administration;
• history of allergic reaction or intolerance to study medication(s);
• had a known diagnosis of dementia of any type, as defined in the DSM-IV.

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Yu-Li Hospital: collaborator

Study Sites (1)

Department of Psychiatry, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (2)

• Breier A, Meehan K, Birkett M, David S, Ferchland I, Sutton V, Taylor CC, Palmer R, Dossenbach M, Kiesler G, Brook S, Wright P. A double-blind, placebo-controlled dose-response comparison of intramuscular olanzapine and haloperidol in the treatment of acute agitation in schizophrenia. Arch Gen Psychiatry. 2002 May;59(5):441-8. doi: 10.1001/archpsyc.59.5.441.

  PMID: 11982448 BACKGROUND

• Huang CL, Hwang TJ, Chen YH, Huang GH, Hsieh MH, Chen HH, Hwu HG. Intramuscular olanzapine versus intramuscular haloperidol plus lorazepam for the treatment of acute schizophrenia with agitation: An open-label, randomized controlled trial. J Formos Med Assoc. 2015 May;114(5):438-45. doi: 10.1016/j.jfma.2015.01.018. Epub 2015 Mar 17.

  PMID: 25791540 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Psychomotor Agitation

Interventions

Olanzapine; Lorazepam; Haloperidol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Tzung-Jeng Hwang
• Organization: National Taiwan University Hospital

tjhwang@ntu.edu.tw

+886-2-23123456

Study Officials

• Tzung-Jeng Hwang, MD, MPH, PhD

  Department of Psychiatry, National Taiwan University Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: July 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 15, 2014
• Results First Posted: September 15, 2014

Record last verified: 2014-09

Locations

TW (1)