Status:
COMPLETED
A Study Using Rapid Acting Intramuscular Olanzapine in Agitated Patients With Schizophrenia
Lead Sponsor:
Eli Lilly and Company
Conditions:
Schizophrenia
Eligibility:
All Genders
20-65 years
Phase:
PHASE2
Brief Summary
To investigate dose-response of Rapid Acting Intramuscular Olanzapine in Agitated Patients with Schizophrenia
Eligibility Criteria
Inclusion
- Patients must have schizophrenia that meets disease diagnostic criteria in DSM-IV-TR
- Patients must be inpatients during the study
- Patients must have a minimum total score of no less than 14 on the five items of the PANSS-EC and at least one individual item score of no less than 4 using the 1-7 scoring system prior to the first injection of study drug
Exclusion
- Patients who have a known history of diabetes mellitus.
- Patients who have received treatment with antipsychotics or other prohibited concomitant medicines within 2 hours prior to the first IM study drug administration
- Patients who have had treatment with benzodiazepines within 4 hours prior to first IM study drug administration.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00316238
Start Date
April 1 2006
End Date
May 1 2007
Last Update
June 8 2007
Active Locations (15)
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1
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.
Akita, Japan, 010-1654
2
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.
Fukuoka, Japan, 832-0077
3
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.
Fukushima, Japan, 966-0902
4
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.
Gunma, Japan, 377-0055