Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents

Stopped early · Not applicable

Conditions studied: Bipolar Disorder, Psychotic Disorders

In brief

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

Key facts

Study ID

NCT00183612

Run by

Massachusetts General Hospital

People needed

68

Starts

2000-05-01

Expected to finish

2007-04-01

Last updated by the study team

2014-01-08

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• McLean Hospital — Belmont, Massachusetts, United States
• Cambridge Health Alliance — Medford, Massachusetts, United States

Full record on ClinicalTrials.gov

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