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 such as age, weight, gender, origin, and smoking status on olanzapine pharmacokinetics in adolescents with schizophrenia or bipolar I disorder. This study will also assess the safety of olanzapine delivered orally.

Condition	Intervention	Phase
Schizophrenia Bipolar Disorder	Drug: Olanzapine	Phase III

Ages Eligible for Study:  13 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients must not be experiencing acute, serious, or unstable medical conditions other than schizophrenia or bipolar I disorder.

Please refer to this study by ClinicalTrials.gov identifier  NCT00113594

There may be multiple sites in this clinical trial.      1-877-CTLILLY (1-877-285-4559) 

New York
      For additonal information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Olean,  New York,  United States; Recruiting

Study ID Numbers:  9483
Record last reviewed:  June 2005
Last Updated:  June 30, 2005
Record first received:  June 9, 2005
ClinicalTrials.gov Identifier:  NCT00113594
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-07-05