Back to resultsComparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Olanzapine Hydrochloride
Haloperidol
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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
Sites / Locations
- 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.
Outcomes
Primary Outcome Measures
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 Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00485901
Brief Title
Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol 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 Type
Interventional
2. Study Status
Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare intramuscular Olanzapine and intramuscular Haloperidol in changing of agitation in patients with schizophrenia
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Olanzapine Hydrochloride
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Assess treatment-emergent adverse events, change in vital signs and extrapyramidal symptoms of IM olanzapine versus IM haloperidol during the study
Title
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
Title
Compare the response rates and time to response during the 2 hours post-first IM injection.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia
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