Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents
Developmental Pharmacokinetics of Psychotropic Drugs: Olanzapine
2 other identifiers
interventional
68
1 country
2
Brief Summary
This study will examine the safety and effectiveness of the antipsychotic drug olanzapine in children and adolescents with bipolar disorder or psychosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2000
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2007
CompletedJanuary 8, 2014
January 1, 2014
6.9 years
September 13, 2005
January 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Olanzapine pharmacokinetics, safety, and effectiveness
Measured over 8 weeks
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
McLean Hospital
Belmont, Massachusetts, 02478, United States
Cambridge Health Alliance
Medford, Massachusetts, 02155, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louise G. Cohen, PharmD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 16, 2005
Study Start
May 1, 2000
Primary Completion
April 1, 2007
Study Completion
April 1, 2007
Last Updated
January 8, 2014
Record last verified: 2014-01