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NCT02824627 · ClinicalTrials.gov registry record · Phase 2

Oxytocin on Irritability/Emotional Dysregulation of Disruptive Behavior and Mood Disorders

A Phase 2 study of Mood Disorder and Disruptive Behavior Disorders, sponsored by University of Nebraska.

Completed
Registry status
Phase 2
Development phase
58
Enrollment target
1
Study location

NCT02824627 is a Phase 2 study of Mood Disorder and Disruptive Behavior Disorders that has completed, run by University of Nebraska. The registered enrollment target is 58 participants, below the 1,299-participant average among 7 other Mood Disorder trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02824627, a Phase 2 study of Mood Disorder and Disruptive Behavior Disorders, has completed, sponsored by University of Nebraska.

COMPLETED
Registry status
Phase 2
Development phase
58 participants
Enrollment target
1
Study location

Study 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

Conditions Studied

Mood Disorder Disruptive Behavior Disorders

Interventions

  • DRUG Placebo
  • DRUG Oxytocin

Study Locations (1)

Nebraska

  • University of Nebraska Medical Center, Department of Psychiatry - Omaha

Trial Details

FieldValue
Enrollment Target 58 participants
Start Date 2017-01-27
Est. Completion 2021-08-10
Phase Phase 2

Sponsor

University of Nebraska

407 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02824627

The ClinicalTrials.gov registry entry for NCT02824627 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,299-participant average among 7 other Mood Disorder trials with a reported enrollment target (96% lower). The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Mood Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02824627 reports 1 study location spanning 1 distinct geographic area - top geographies include Nebraska.

Frequently Asked Questions

What is clinical trial NCT02824627 about?

NCT02824627 is a clinical study titled "Oxytocin on Irritability/Emotional Dysregulation of Disruptive Behavior and Mood Disorders". 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 n...

What is the current status of trial NCT02824627?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 58 participants. The study started on 2017-01-27. Estimated completion is 2021-08-10.

What conditions does trial NCT02824627 study?

This clinical trial studies the following conditions: Mood Disorder, Disruptive Behavior Disorders.

What interventions are being tested in trial NCT02824627?

The interventions under investigation include: Placebo (DRUG), Oxytocin (DRUG).

Who is sponsoring clinical trial NCT02824627?

This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02824627 being conducted?

This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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