Dose Response Relationship of Oxytocin on Irritability in Youths

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Nebraska
• Collaborators: National Institute of Mental Health (NIMH); National Institutes of Health (NIH)
• Treatments: Oxytocin

Criteria

Inclusion Criteria:

• 14-18 years of age

• current diagnosis of ADHD, ODD, CD, or DMDD as determined by the Kiddie-SADS, lifetime version;54

• Clinically significant level of irritability as defined by a score of ≥4 on the Affective Reactivity Index (ARI)

• If currently on medication, treatment must be stable for at least 2 weeks with stimulant medication, and at least 4 weeks with alpha 2 agonist, atomoxetine, antipsychotics, mood stabilizers, or antidepressant.

Exclusion Criteria:

• Comorbid psychotic, tic, autism spectrum disorder, or substance use disorders, or current diagnosis of bipolar disorder; -Major medical illness that prohibits OXT administration (e.g., severe liver disease, seizure disorder, metabolic disorder)

• Past history of allergic reaction to OXT and its intranasal product

• History of CNS disease (including history of seizure, epilepsy, CNS tumor, CNS hemorrhage, or serious CNS infection including meningitis or encephalitis)

• A positive urine pregnancy test

• A positive urine drug screen or currently active diagnosis of substance use disorder

• Wechsler Abbreviated Scale of Intelligence (WASI-2; two subset form) scores <70

• Metal in body (i.e., hearing aid, cardiac pacemaker, bone plates, braces, non-removable piercing/implants, etc.), claustrophobia, or any other condition that would preclude MRI scanning.