Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00183612

Purpose

This study will examine the safety and effectiveness of the antipsychotic drug olanzapine in children and adolescents with bipolar disorder or psychosis.

Condition	Intervention
Bipolar Disorder Psychotic Disorders	Drug: Olanzapine

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Developmental Pharmacokinetics of Psychotropic Drugs: Olanzapine

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Child Mental Health Mental Health Psychotic Disorders

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Olanzapine pharmacokinetics, safety, and effectiveness

Estimated Enrollment:	68
Study Start Date:	May 2000

Detailed Description:

Numerous advancements in mental health treatment have been made over the past decade. Unfortunately, these advancements have focused on adults and have not been fully extended to children and adolescents. With limited pediatric information on the pharmacokinetics and pharmacodynamics for drugs used to treat mental health problems, psychiatrists are prescribing drugs for children using data extrapolated from adults, which may lead to potentially life-threatening results. Olanzapine is widely prescribed to treat both children and adults. This study will determine the safety and effectiveness of olanzapine in children and adolescents with mental health disorders. The study will also compare the effects of gender, development, body composition, and metabolic genotype and phenotype on how olanzapine works.

All participants will receive olanzapine for up to 8 weeks. Blood collection will occur at each weekly study visit. On Visit 1, participants will receive their first dose of olanzapine and repeated blood collection will occur every hour for 24 hours. Blood collection will be used to determine the time it takes for olanzapine to be absorbed into the body, its duration of action, the extent of its distribution in the body, the manner in which it is excreted from the body, and its effects on organs of the body.

Eligibility

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of bipolar disorder with mania, mixed mania, or psychosis not otherwise specified
Meet certain laboratory result requirements
Have taken either lithium or valproate for 4 weeks or longer with no or only partial response
Parent or guardian willing to provide informed consent

Exclusion Criteria:

History of other serious unstable illness requiring medication
Diabetes mellitus
Abnormal physical examination and electrocardiogram (EKG) results
At risk for suicide or homicide (based on an assessment of suicidal history, intent or plan, mental state, mood, and substance use)
IQ less than 65
History of organic brain disease or seizure disorder
Recent exposure to an infectious disease, such as tuberculosis (TB) or meningitis
Current use of drugs that may interfere with the metabolism of olanzapine and unwilling to discontinue use during the study
Body mass index (BMI) less than the 5th OR greater than the 95th percentile for age and gender
History of smoking within 1 year prior to study entry
Pregnancy or breastfeeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183612

Locations

United States, Massachusetts
Cambridge Health Alliance
Medford, Massachusetts, United States, 02155
McLean Hospital
Belmont, Massachusetts, United States, 02478

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Louise G. Cohen, PharmD

Massachusetts General Hospital

More Information

No publications provided

Study ID Numbers:	K08 MH01765, DSIR CT-M
Study First Received:	September 13, 2005
Last Updated:	April 13, 2007
ClinicalTrials.gov Identifier:	NCT00183612 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Child
Adolescent
Mental Health

Olanzapine
Pharmacokinetics
Pharmacology

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Olanzapine
Psychotropic Drugs
Antiemetics
Affective Disorders, Psychotic
Pathologic Processes
Mental Disorders
Therapeutic Uses
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Tranquilizing Agents
Disease
Bipolar Disorder
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010