Bipolar Disorder Clinical Trial
Official title:
Developmental Pharmacokinetics of Psychotropic Drugs: Olanzapine
This study will examine the safety and effectiveness of the antipsychotic drug olanzapine in children and adolescents with bipolar disorder or psychosis.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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