Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents

Bipolar Disorder Clinical Trial

Official title:

Developmental Pharmacokinetics of Psychotropic Drugs: Olanzapine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00183612
• Other study ID #: K08MH001765
• Secondary ID: K08MH001765DSIR
• Status: Terminated
• Phase: N/A
• First received: September 13, 2005
• Last updated: January 7, 2014
• Start date: May 2000
• Est. completion date: April 2007

Study information

• Verified date: January 2014
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Olanzapine

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts
United States	Cambridge Health Alliance	Medford	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Olanzapine pharmacokinetics, safety, and effectiveness		Measured over 8 weeks	Yes