Oxytocin on Irritability/Emotional Dysregulation of Disruptive Behavior and Mood Disorders
Status:
Recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
Irritability and emotional dysregulation are recognized as serious aspects of psychopathology
seen in in pediatric psychiatric patients. While various behavioral as well as
psychopharmacological interventions have shown some efficacy in improving irritability and
emotional dysregulation, there are no data determining the neurobiological mechanism of
effect at the neural level. Previous studies have demonstrated that heightened amygdala
response to negative emotional stimuli is closely related to irritability and emotional
dysregulation in children and adolescents. Also, there are studies showing administration of
oxytocin can decrease the heightened amygdala response to negative emotional stimuli across
various psychiatric diagnoses. This study is a double-blind randomized trial of oxytocin for
irritability and emotional dysregulation in the pediatric population. Neuroimaging modalities
of fMRI and MEG are employed to probe the neuro-circuitry changes occurring as a result of
the oxytocin intervention, specifically including heightened amygdala response to negative
emotional stimuli and dysfunctional fronto-amygdala connectivity. The investigators will also
investigate the genetic sequence of the oxytocin receptor in the study participants and its
relationship with symptom profile and neural activity changes. Children and adolescents (age
10-18) with a diagnosis of disruptive mood and/or behavior disorders (including Attention
Deficit/Hyperactivity Disorder [ADHD], Oppositional Defiant Disorder [ODD], Conduct Disorder
[CD], and Disruptive Mood Dysregulation Disorder [DMDD]), and clinically significant levels
of irritability and emotional dysregulation as measured by the Affective Reactivity Index
Scale (score>/= 4).
2 weeks randomized, double-blind treatment with intranasal oxytocin (24 IU daily, or 12 IU
daily if the weight is < 40kg) with assessment of diagnosis, symptom profiles (the Affective
Reactivity Index [ARI], Inventory of Callous-Unemotional Trait [ICU], Behavior Assessment
System for Children, second version [BASC-2], and Clinical Global Impression [CGI]) and pre-
and post-oxytocin treatment neuroimaging (fMRI and MEG). The genetic sample will be obtained
via buccal mucosa sampling.
Participants may receive outpatient clinically indicated follow-up care in the UNMC
department of psychiatry or other local community agency as appropriate.