Olanzapine Treated Adolescents With Schizophrenia or Bipolar I Disorder

Condition(s) targeted: Schizophrenia; Bipolar Disorder

Intervention: Olanzapine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Eli Lilly and Company

Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Study Director, Affiliation: Eli Lilly and Company

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.

Official title: Population Pharmacokinetic Study in Adolescent Patients With Schizophrenia or Bipolar I Disorder Treated With Olanzapine

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Primary outcome:

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 outcome:

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

Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): 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, 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.

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, San Juan, Puerto Rico

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, Moscow, Russian Federation

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

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

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

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

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, Eagle, Idaho, United States

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, Lake Charles, Louisiana, United States

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, Glen Burnie, Maryland, United States

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, Albuquerque, New Mexico, United States

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, Olean, New York, United States

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, New York, New York, United States

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, Cincinnati, Ohio, United States

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, Houston, Texas, United States

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, Portsmouth, Virginia, United States

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, Kirkland, Washington, United States

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, West Allis, Wisconsin, United States

Lilly Clinical Trial Registry

Starting date: June 2005
Ending date: March 2006
Last updated: November 5, 2007