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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Page 1 of 4 (15 locations)

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