Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder; Psychotic Disorders
Intervention: Olanzapine (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: National Institute of Mental Health (NIMH) Official(s) and/or principal investigator(s):
Louise G. Cohen, PharmD, Principal Investigator, Affiliation: Massachusetts General Hospital
Summary
This study will examine the safety and effectiveness of the antipsychotic drug olanzapine in
children and adolescents with bipolar disorder or psychosis.
Clinical Details
Official title: Developmental Pharmacokinetics of Psychotropic Drugs: Olanzapine
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: Olanzapine pharmacokinetics, safety, and effectiveness
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
Minimum age: 6 Years.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Cambridge Health Alliance, Medford, Massachusetts 02155, United States
McLean Hospital, Belmont, Massachusetts 02478, United States
Additional Information
Starting date: May 2000
Last updated: April 13, 2007
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