Status:
TERMINATED
Dose Response Relationship of Oxytocin on Irritability in Youths
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Irritable Mood
Eligibility:
All Genders
14-18 years
Phase:
PHASE1
PHASE2
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 clinicall...
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 social/emotional stimuli. Although many studies argue tha...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03863288
Start Date
February 18 2022
End Date
February 27 2024
Last Update
March 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Nebraska Medical Center, Department of Psychiatry
Omaha, Nebraska, United States, 61898-5581