Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00485901
Recruitment Status : Completed
First Posted : June 13, 2007
Last Update Posted : June 13, 2007
Information provided by:
Eli Lilly and Company

June 11, 2007
June 13, 2007
June 13, 2007
July 2004
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Assess the efficacy of IM olanzapine compared with IM haloperidol in changing of agitation from baseline to 2 hours post-first IM injection
Same as current
No Changes Posted
  • 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.
Same as current
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Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia
A Double-Blind Randomized Comparison of the Efficacy and Safety of Intramuscular Olanzapine and Intramuscular Haloperidol in Acutely Agitated Patients With Schizophrenia
The purpose of this study is to compare intramuscular Olanzapine and intramuscular Haloperidol in changing of agitation in patients with schizophrenia
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Drug: Olanzapine Hydrochloride
  • Drug: Haloperidol
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
January 2005
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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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
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Eli Lilly and Company
Not Provided
Study Director: 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
Eli Lilly and Company
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP