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OpenTrials
Completed

NCT Number: NCT00485901

Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olanzapine Hydrochloride

Drug

Haloperidol

Drug

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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Jun 13, 2007
Registry last updated
Jun 13, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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