Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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:

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   (Child, Adult)
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

Responsible Party: Maurizio Fava, MD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00183612     History of Changes
Other Study ID Numbers: 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:
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

ClinicalTrials.gov processed this record on September 27, 2016