Status:
COMPLETED
Comparison of Intramuscular Olanzapine Depot to Oral Olanzapine and Low-Dose Depot in Patients With Schizophrenia
Lead Sponsor:
Eli Lilly and Company
Conditions:
Schizophrenic Disorders
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a randomized, double-blind study to determine how well intramuscular (IM) olanzapine depot works compared to oral olanzapine; evaluate the safety and tolerability of IM olanzapine depot compar...
Eligibility Criteria
Inclusion
- Patients must have schizophrenia
- Patients must be clinically stable on antipsychotic medication
- Patients must be retrospectively judged by investigators, based on clinical interview and impression, to have been stable (with respect to their symptoms of schizophrenia) for at least 4 weeks entry into the study
- Patients must be an outpatient and have BPRS positive items scores of 4 or less to enter the study
- Female patients of childbearing potential must be using a medically accepted means of contraception.
Exclusion
- Patients must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry.
- Female patients must not be pregnant or breast-feeding
- Patients must not be experiencing acute, serious, or unstable medical conditions other than schizophrenia
- Patients must not require concomitant treatment with any other medication with primarily central nervous system activity, including antidepressants, mood stabilizers, and anticonvulsants.
- Patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
1205 Patients enrolled
Trial Details
Trial ID
NCT00088491
Start Date
June 1 2004
End Date
October 1 2006
Last Update
June 22 2007
Active Locations (4)
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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.
Pitkäniemi, Finland, 33380
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.
Ankara, Turkey (Türkiye)
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.
Istanbul, Turkey (Türkiye), 34787
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.
Izmir, Turkey (Türkiye)