Olanzapine Treated Adolescents With Schizophrenia or Bipolar I Disorder

Lilly

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Bipolar Disorder

Treatments

Drug: Olanzapine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00113594

9483

F1D-MC-HGMF

Details and patient eligibility

About

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.

Sex

All

Ages

13 to 17 years old

Volunteers

No Healthy Volunteers

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.