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Characterization and Brain Mechanisms of Frustration in Youth With Severe Irritability or Attention Deficit Hyperactivity Disorder (ADHD)

NCT05357495 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-01-10

No results posted yet for this study

Summary

Background:

Irritability is an elevated proneness to anger. Children with irritability have difficulty tolerating frustration. They get angry and have temper outbursts more easily than their others their age. Irritability is a symptom of DMDD and ADHD. (DMDD is disruptive mood dysregulation disorder. ADHD is attention deficit/hyperactivity disorder.) Yet the reasons why some children get irritated easily are not well understood.

Objective:

To use brain imaging methods to study responses to frustration in youth.

Eligibility:

Youth aged 8 to 17 years with severe irritability (including those diagnosed with DMDD) and/or ADHD. Healthy volunteers are also needed. All participants are already enrolled in studies 02-M-0021 or 01-M-0192.

Design:

Participants will visit the clinic 3 times. The second and third visits will be 3 to 4 weeks apart.

The first visit will be an enrollment visit. They will receive training on the tasks they will do during the study. Participants and their parents will take surveys. They will answer questions about their moods and feelings.

Participants will train for an MRI scan. They will lie in a mock scanner tube and hear the noises an MRI makes.

On the second and third visits, participants will have real MRI scans. They will play a computer game or watch a movie during each scan. The scans will last about 1 hour.

The week after each scan, participants will wear a device on their wrist to measure their heart rate and activity level. Participants and their parent will use a smartphone to answer questions about how they are feeling and acting. Participants who do not have smartphones will be given one to use during the study.

Conditions

  • Disruptive Mood Dysregulation Disorder
  • Attention Deficit Hyperactivity Disorder
  • Normal Physiology

Interventions

BEHAVIORAL

Affective Posner fMRI frustration induction task

During the frustration induction paradigm, children play a game with monetary reward. The game is rigged, thus inducing frustration. The control task does not have any reward component. All participants complete both the control task scanning session and the frustration induction scanning session.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    lead NIH

Principal Investigators

  • Ellen Leibenluft, M.D. · National Institute of Mental Health (NIMH)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-05
Primary Completion
2023-01-05
Completion
2023-01-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05357495 on ClinicalTrials.gov