Status:
TERMINATED
Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Bipolar Disorder
Psychotic Disorders
Eligibility:
All Genders
6-18 years
Phase:
NA
Brief Summary
This study will examine the safety and effectiveness of the antipsychotic drug olanzapine in children and adolescents with bipolar disorder or psychosis.
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 adolesce...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00183612
Start Date
May 1 2000
End Date
April 1 2007
Last Update
January 8 2014
Active Locations (2)
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1
McLean Hospital
Belmont, Massachusetts, United States, 02478
2
Cambridge Health Alliance
Medford, Massachusetts, United States, 02155