Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00183612
Status:
TERMINATED
Last Update Posted:
2014-01-08
First Post:
2005-09-13
Brief Title:
Determining the Safety and Effectiveness of Olanzapine in Children and Adolescents
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Developmental Pharmacokinetics of Psychotropic Drugs Olanzapine
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DSIR CT-M | US NIH GrantContract | None | httpsreporternihgovquickSearchK08MH001765 |
| K08MH001765 | NIH | None | None |