Trials / Terminated
TerminatedNCT00183612
Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents
Developmental Pharmacokinetics of Psychotropic Drugs: Olanzapine
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 68 (planned)
- Sponsor
- Massachusetts General Hospital · Academic / Other
- Sex
- All
- Age
- 6 Years – 18 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olanzapine |
Timeline
- Start date
- 2000-05-01
- Primary completion
- 2007-04-01
- Completion
- 2007-04-01
- First posted
- 2005-09-16
- Last updated
- 2014-01-08
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00183612. Inclusion in this directory is not an endorsement.