Olanzapine Treated Adolescents With Schizophrenia or Bipolar I Disorder

Eli Lilly and Company100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Schizophrenia Bipolar Disorder

Interventions

OlanzapineDRUG

Eligibility

Sex: ALLMin age: 13 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (17)

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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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

National City, California, United States

Poway, California, United States

Fort Lauderdale, Florida, United States

Eagle, Idaho, United States

Lake Charles, Louisiana, United States

Glen Burnie, Maryland, United States

Albuquerque, New Mexico, United States

New York, New York, United States

Olean, New York, United States

...and 7 more locations