Status:
COMPLETED
Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia
Lead Sponsor:
Eli Lilly and Company
Conditions:
Schizophrenia
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Key objectives of this clinical study are to: * Determine how well intramuscular (IM) olanzapine depot works compared to placebo * Evaluate the safety and tolerability of IM olanzapine depot compared...
Eligibility Criteria
Inclusion
- Patients must have schizophrenia and be experiencing a psychotic episode
- Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent
- Patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to the study entry
- Female patients must not be pregnant or breast-feeding
- Female patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia
Exclusion
- Patients who were previously treated with olanzapine and are considered to be treatment-resistant to olanzapine, in the opinion of the investigator
- One or more seizures without a clear and resolved etiology is exclusionary. However, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered.
- Treatment with clozapine within 4 weeks prior to visit 1
- DSM-IV or DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days
- Treatment with remoxipride within 6 months (180 days) prior to visit 1
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT00088478
Start Date
June 1 2004
End Date
April 1 2005
Last Update
June 12 2007
Active Locations (37)
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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 hrs, EST), or speak with your personal physician.
National City, California, United States
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 hrs, EST), or speak with your personal physician.
Orange, California, United States
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 hrs, EST), or speak with your personal physician.
Rosemead, California, United States
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 hrs, EST), or speak with your personal physician.
San Diego, California, United States