Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Olanzapine

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