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OpenTrials
Completed

NCT Number: NCT00113594

Olanzapine Treated Adolescents With Schizophrenia or Bipolar I Disorder

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.

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Key information

Conditions

Schizophrenia Bipolar Disorder Bipolar and Related Disorders Mental Disorders Mood Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Olanzapine

Drug

Primary outcomes

  1. To characterize olanzapine pharmacokinetics

  2. The inter- and intra-subject variabilities of olanzapine pharmacokinetics

  3. 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

  1. 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

  2. To assess the effect of olanzapine on overall symptomatology

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2006
First posted
Jun 10, 2005
Registry last updated
Nov 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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