Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Bipolar Disorder; Psychotic Disorders	Drug: Olanzapine	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	68 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Developmental Pharmacokinetics of Psychotropic Drugs: Olanzapine
Study Start Date :	May 2000
Actual Primary Completion Date :	April 2007
Actual Study Completion Date :	April 2007

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Olanzapine pharmacokinetics, safety, and effectiveness [ Time Frame: Measured over 8 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	6 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Massachusetts General Hospital

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Louise G. Cohen, PharmD	Massachusetts General Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Maurizio Fava, MD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00183612 History of Changes
Other Study ID Numbers:	K08MH001765 ( U.S. NIH Grant/Contract ); DSIR CT-M
First Posted:	September 16, 2005
Last Update Posted:	January 8, 2014
Last Verified:	January 2014

Keywords provided by Maurizio Fava, MD, Massachusetts General Hospital:

Child; Adolescent; Mental Health	Olanzapine; Pharmacokinetics; Pharmacology

Additional relevant MeSH terms:

Disease; Bipolar Disorder; Psychotic Disorders; Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Olanzapine; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs	Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents