Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia

Condition(s) targeted: Schizophrenia

Intervention: Olanzapine Hydrochloride (Drug); Haloperidol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
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), Study Director, Affiliation: Eli Lilly and Company

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

Official title: A Double-Blind Randomized Comparison of the Efficacy and Safety of Intramuscular Olanzapine and Intramuscular Haloperidol in Acutely Agitated Patients With Schizophrenia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Secondary outcome:

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

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

Lilly Clinical Trial Registry

Starting date: July 2004
Last updated: June 11, 2007