Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents

This study has been terminated.

Sponsor:

Collaborator:

National Institute of Mental Health (NIMH)

Information provided by (Responsible Party):

Maurizio Fava, MD, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT00183612

First received: September 13, 2005

Last updated: January 7, 2014

Last verified: January 2014

History of Changes

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:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Developmental Pharmacokinetics of Psychotropic Drugs: Olanzapine

Resource links provided by NLM:

MedlinePlus related topics: Bipolar Disorder Mental Disorders Psychotic Disorders

Drug Information available for: Olanzapine Olanzapine pamoate

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Olanzapine pharmacokinetics, safety, and effectiveness [ Time Frame: Measured over 8 weeks ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	68
Study Start Date:	May 2000
Study Completion Date:	April 2007
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided


Responsible Party:	Maurizio Fava, MD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00183612 History of Changes
Other Study ID Numbers:	K08 MH01765, K08MH001765, DSIR CT-M
Study First Received:	September 13, 2005
Last Updated:	January 7, 2014
Health Authority:	United States: Federal Government

Keywords provided by Massachusetts General Hospital:


Child Adolescent Mental Health	Olanzapine Pharmacokinetics Pharmacology

Additional relevant MeSH terms:


Psychotic Disorders Mental Disorders Schizophrenia and Disorders with Psychotic Features Olanzapine Antiemetics Antipsychotic Agents Autonomic Agents Central Nervous System Agents Central Nervous System Depressants Gastrointestinal Agents Molecular Mechanisms of Pharmacological Action	Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Serotonin Agents Serotonin Uptake Inhibitors Therapeutic Uses Tranquilizing Agents

ClinicalTrials.gov processed this record on March 03, 2015

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