Bipolar Disorder, Schizophrenia
Conditions
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 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.
Interventions
DRUGOlanzapine
Sponsors
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
No
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, and either confirmed previously by K-SADS-PL or be confirmed by K-SADS-PL at Visit 1.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize olanzapine pharmacokinetics | — |
| The inter- and intra-subject variabilities of olanzapine pharmacokinetics | — |
| The potential influence of patient factors such as age, weight, gender, origin, and smoking status on olanzapine pharmacokinetics in adolescents 13-17 years of age that have been diagnosed with schizophrenia or bipolar I disorder | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of olanzapine delivered orally by measuring adverse events, change in vital signs, weight, laboratory analytes, electrocardiogram (ECG), and severity of extrapyramidal symptoms | — |
| To assess the effect of olanzapine on overall symptomatology | — |
Countries
Puerto Rico, Russia, United States
Outcome results
None listed