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CompletedNCT00485901Updated Jun 13, 2007

Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia

A Phase 3 interventional study of Olanzapine Hydrochloride and Haloperidol in Schizophrenia, sponsored by Eli Lilly and Company. Completed at 1 site in Taiwan. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2007-06-13.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Schizophrenia

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03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 50 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
50 participants (actual)

Interventions

  • DrugOlanzapine Hydrochloride
  • DrugHaloperidol
06

What researchers measure

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

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

  2. 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

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

07

Study locations

1 site
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00485901
Lead sponsor
Eli Lilly and Company
First posted
Jun 13, 2007
Start date
Jul 2004
Completion
Jan 2005
Last update
Jun 13, 2007

Study contacts

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 · Eli Lilly and Company
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2007. You cannot join it, but the record below documents what was studied.

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