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
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05111548 -
Brain Stimulation and Cognitive Training - Efficacy
|
N/A | |
| Completed |
NCT02855762 -
Targeting the Microbiome to Improve Clinical Outcomes in Bipolar Disorder
|
N/A | |
| Recruiting |
NCT05915013 -
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components of the Anti-Depressant Ketamine Response
|
Phase 1 | |
| Recruiting |
NCT05206747 -
Ottawa Sunglasses at Night for Mania Study
|
N/A | |
| Completed |
NCT02513654 -
Pharmacokinetics, Safety and Tolerability of Repeat Dosing Lamotrigine in Healthy Chinese Subjects
|
Phase 1 | |
| Recruiting |
NCT06313918 -
Exercise Therapy in Mental Disorders-study
|
N/A | |
| Completed |
NCT02304432 -
Targeting a Genetic Mutation in Glycine Metabolism With D-cycloserine
|
Early Phase 1 | |
| Recruiting |
NCT06197048 -
Effect of Nutritional Counseling on Anthropometry and Biomarkers in Patients Diagnosed With Schizophrenia/Psychosis or Bipolar Affective Disorder
|
N/A | |
| Completed |
NCT03497663 -
VIA Family - Family Based Early Intervention Versus Treatment as Usual
|
N/A | |
| Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
| Completed |
NCT02212041 -
Electronic Cigarettes in Smokers With Mental Illness
|
N/A | |
| Recruiting |
NCT05030272 -
Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings
|
N/A | |
| Recruiting |
NCT04298450 -
ED to EPI: Using SMS to Improve the Transition From the Emergency Department to Early Psychosis Intervention
|
N/A | |
| Active, not recruiting |
NCT03641300 -
Efficacy of Convulsive Therapies for Bipolar Depression
|
N/A | |
| Not yet recruiting |
NCT04432116 -
Time and Virtual Reality in Schizophrenia and Bipolar Disorder
|
N/A | |
| Terminated |
NCT02893371 -
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies
|
||
| Completed |
NCT02970721 -
Use of Psychotropic Medications Among Pregnant Women With Bipolar Disorder
|
||
| Terminated |
NCT02909504 -
Gao NARASD Lithium Study
|
Phase 4 | |
| Recruiting |
NCT03088657 -
Design and Methods of the Mood Disorder Cohort Research Consortium (MDCRC) Study
|
||
| Recruiting |
NCT02481245 -
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
|
Phase 2 |