Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia

NCT ID: NCT00485901

Last Updated: 2007-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2005-01-31

Brief Summary

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

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Olanzapine Hydrochloride

Intervention Type DRUG

Haloperidol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 38958149 (View on PubMed)

Other Identifiers

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F1D-TW-S025

Identifier Type: -

Identifier Source: secondary_id

6409

Identifier Type: -

Identifier Source: org_study_id