Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia

NCT00485901 | Completed Phase 3

• 2 other identifiers: 6409F1D-TW-S025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare intramuscular Olanzapine and intramuscular Haloperidol in changing of agitation in patients with schizophrenia

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Assess the efficacy of IM olanzapine compared with IM haloperidol in changing of agitation from baseline to 2 hours post-first IM injection

Secondary Outcomes (3)

• Assess treatment-emergent adverse events, change in vital signs and extrapyramidal symptoms of IM olanzapine versus IM haloperidol during the study

• Assess the efficacy of IM olanzapine compared with IM haloperidol from baseline to 15 min, 30 min, 60 min and 120 minutes post-first IM injection

• Compare the response rates and time to response during the 2 hours post-first IM injection.

Interventions

Olanzapine Hydrochloride DRUG

Haloperidol DRUG

Eligibility Criteria

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

You may qualify if:

• Male or female patients, between the ages of 18 and 65
• Patients must have diagnosis of schizophrenia that meets disease diagnostic criteria as defined in DSM-IV
• Patients must be considered, by the investigator, to be clinically agitated and appropriate candidates for treatment with IM medication. Investigator must believe that it is safe to administer IM olanzapine and IM comparator to the patients with respect to the safety profile of these drugs (including the anticholinergic properties of Olanzapine IM or the comparator agent)
• Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
• Patient must be hospitalized during the study

You may not qualify if:

• Previous participation (treatment with study drug) in a Lilly sponsored intra-muscular olanzapine clinical trial
• Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months
• Have a known diagnosis of dementia of any type, as defined in the DSM-IV or DSM-IV-TR
• Documented history of allergic reaction to study medication(s)
• Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Taipei, Taiwan

Location

Related Publications (1)

• 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

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Schizophrenia

Interventions

olanzapine-fluoxetine combination; Haloperidol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2007
• First Posted: June 13, 2007
• Study Start: July 1, 2004
• Study Completion: January 1, 2005
• Last Updated: June 13, 2007

Record last verified: 2007-06

Locations

TW (1)