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Dose Response Relationship of Oxytocin on Irritability in Youths

NCT03863288 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-03-14

No results posted yet for this study

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.

Conditions

  • Irritable Mood

Interventions

PROCEDURE

Functional MRI (fMRI)

Functional MRI (fMRI) scan with affective/cognitive tasks

DRUG

Oxytocin Intranasal Spray 8 International Unit (8IU)

Oxytocin intranasal spray liquid administration

DRUG

Oxytocin intranasal spray 24 International Unit (24IU)

Oxytocin intranasal spray liquid administration

DRUG

Oxytocin intranasal spray 48 International Unit (48IU)

Oxytocin intranasal spray liquid administration

DRUG

Oxytocin intranasal spray 80 International Unit (80IU)

Oxytocin intranasal spray liquid administration

DRUG

Placebo

Placebo intranasal spray liquid administration

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Soonjo Hwang, MD · University of Nebraska

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-18
Primary Completion
2024-02-27
Completion
2024-02-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03863288 on ClinicalTrials.gov