Dose Response Relationship of Oxytocin on Irritability in Youths

Stopped early · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Irritable Mood

In brief

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.

Key facts

Study ID

NCT03863288

Run by

University of Nebraska

People needed

60

Starts

2022-02-18

Expected to finish

2024-02-27

Last updated by the study team

2025-03-14

Who can join

Age: 14 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 14-18 years of age
• current diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD), Oppositional Defiant Disorder (ODD), Conduct Disorder (CD), or Disruptive Mood Dysregulation Disorder (DMDD) as determined by the Kiddie-Schedule for Affective Disorders and Schizophrenia (K-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.

You may not qualify if…

• 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 Central Nervous System (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 the 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.

Where it is running

• University of Nebraska Medical Center, Department of Psychiatry — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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