At a glance
ClinicalIndex Comparison Record- ✓Age 10–18 years
- ✓Current diagnosis of ADHD, ODD, CD, or DMDD confirmed by structured diagnostic interview
- ✓Clinically significant irritability with ARI score ≥4
- ✓If on medication, must be stable on stimulant, alpha-2 agonist, atomoxetine, or antidepressant for ≥6 weeks
- ✕Comorbid psychotic, tic, pervasive developmental, or substance abuse disorders
- ✕Major medical illness precluding oxytocin treatment (e.g., severe liver disease, seizure disorder, metabolic disorder)
- ✕History of significant worsening of psychiatric symptoms after prior oxytocin treatment
- ✕History of allergic reaction to oxytocin or its nasal spray product
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Investigating the Impact of Oxytocin on Irritability/Emotional Dysregulation in Children and Adolescents With Disruptive Behavior and Mood Disorders, and the Possible Mediating Role of Amygdala Activity
In Brief
A Phase 2 clinical trial evaluating Oxytocin and Placebo for Mood Disorder and Disruptive Behavior Disorders. Completed, enrolled 58 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
A growing body of data shows that intra-nasal administration of oxytocin has promise for treating a host of psychiatric disorders. Considerable data indicates that oxytocin reduces amygdala response to negative stimuli in patients with generalized anxiety disorder, borderline personality disorder, and post-traumatic stress disorder. Given that one of the potential underlying neurobiological mechanisms of irritability and emotional dysregulation in pediatric population with disruptive behavior and mood disorder is the hyperactivity of amygdala to negative emotional stimuli, and that oxytocin reduces this, it is critical to determine the extent to which this intervention improves irritability and emotional dysregulation in children and adolescents with disruptive behavior and mood disorders.
Inactive substance administered in volume equivalent to volume administered in active treatment arm.