Status:
COMPLETED
Olanzapine Treated Adolescents With Schizophrenia or Bipolar I Disorder
Lead Sponsor:
Eli Lilly and Company
Conditions:
Schizophrenia
Bipolar Disorder
Eligibility:
All Genders
13-17 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to characterize olanzapine pharmacokinetics: the inter- and intra- subject variabilities of olanzapine pharmacokinetics; and the potential influence of patient factors suc...
Eligibility Criteria
Inclusion
- Male or female patients, 13 through 17 years of age (must not have reached their 18th birthday prior to Visit 1).
- Female patients must not be pregnant or nursing.
- Patient and patient's parent/authorized legal representative must have a level of understanding sufficient to perform all tests and examinations required by the protocol, and must have given informed consent.
- Patient must have a previously documented diagnosis of schizophrenia or bipolar I according to the DSM-IV-TR, and either confirmed previously by K-SADS-PL or be confirmed by K-SADS-PL at Visit 1.
Exclusion
- Patients must not be experiencing acute, serious, or unstable medical conditions other than schizophrenia or bipolar I disorder.
- Patients are not allowed into the study if they currently meet the criteria for the depressed phase of bipolar disorder or are diagnosed with Bipolar II Disorder.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
March 1 2006
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00113594
Start Date
June 1 2005
End Date
March 1 2006
Last Update
November 6 2007
Active Locations (17)
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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
Cerritos, 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 hours, EST), or speak with your personal physician
National City, 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 hours, EST), or speak with your personal physician
Poway, 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 hours, EST), or speak with your personal physician
Fort Lauderdale, Florida, United States