Ignite Creation Date:
2024-05-06 @ 12:51 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03863288
Status:
TERMINATED
Last Update Posted:
2024-04-26
First Post:
2018-09-25
Brief Title:
Dose Response Relationship of Oxytocin on Irritability in Youths
Sponsor:
University of Nebraska
Organization:
University of Nebraska
Study Overview
Official Title:
Dose-Response Relationship and Pharmacokinetics of Intranasal Oxytocin on Neural Impact in Youth With High Levels of Irritability
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Per DSMBs recommendation
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study is a randomized double-blind proof of concept PoC study on the neural impact of intranasal oxytocin OXT administration for adolescents age 14 to 18 demonstrating a clinically significant level of irritability as defined by a score of 4 on the Affective Reactivity Index ARI Planned enrollment is 80 subjects over 3 years
Detailed Description:
Endogenous oxytocin OXT has been a focus of prior psychiatric research due to its role in pro-social behavior and modulation of response to socialemotional stimuli Although many studies argue that the intranasal administration of OXT can produce behavioral as well as neural changes there is surprisingly little comprehensive research on this issue Most of the previous studies are limited by using a single dose of intranasal OXT in small samples and there is no current consensus regarding appropriate dosage and very little data on neural impact as a function of dose There has been little consideration of the relation between pharmacokinetics peripheral level of OXT after administration and the degree of induced neural changes None of these issues have been studied in a pediatric population with clinically significant psychopathology This study is proposed to determine the extent to which neural changes are induced by OXT intranasal administration by examining the dose-response relationship the degree of neural changes induced by various doses of OXT and the correlation of pharmacokinetics peripheral level of OXT after administration and the induced neural changes in youths with clinically significant psychopathology The form of psychopathology targeted is irritability the increased propensity to exhibit anger relative to peersOne of the neurobiological mechanisms of irritability implicates dysfunction in the acute threat response system OXT with its most commonly proposed mechanism being reduction of hyperactivity in the acute threat response system is a potentially promising agent to induce neural changes in the target brain areas of the acute threat response system for youths with high levels of irritability The study aims to quantify the extent to which different doses of OXT will reduce the activation of the acute threat response system to emotional stimuli in youths with high levels of irritability Both resting state and task-based functional MRI will be used using affective-cognitive tasks with demonstrated test-retest reliability and capability of capturing the core target areas of OXT administration in the acute threat response system Pharmacokinetics plasma and saliva level after OXT administration will be examined to determine correlation with the induced neural changes in the target areas
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U01MH120155-01A1 | NIH | None | httpsreporternihgovquickSearch1U01MH120155-01A1 |