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

NCT05357495 | Withdrawn

• 2 other identifiers: 10000774000774-M
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Magnetic Resonance Imaging; Resting State; Task Based

Outcome Measures

Primary Outcomes (2)

• prediction of irritability ratings by global efficiency

  global efficiency of brain modules in resting state after frustration will be used to predict irritability ratings obtained throughout the one week after each of two scanning sessions

  one week after each of two scanning sessions, when ecological momentary assessment ratings are completed. The two scanning sessions will be 2-5 weeks apart.

• Variance of information (VIn) measures

  VIn metric will be used to identify the brain modules making the largest contribution to network reconfiguration throughout frustration

  data are obtained throughout each of the two scanning sessions. The two scanning sessions will be 2-5 weeks apart.

Secondary Outcomes (2)

• ecological momentary assessment (EMA) measures

  for one week after each of the two scanning sessions

• Diffusion tensor imaging (DTI) metrics

  during first scanning session

Study Arms (1)

frustration and control fMRI tasks

EXPERIMENTAL

all subjects complete one scanning session with frustration induction and one scanning session with the control task.

Behavioral: Affective Posner fMRI frustration induction task

Interventions

Affective Posner fMRI frustration induction task BEHAVIORAL

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.

frustration and control fMRI tasks

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• This study will include patients (i.e., youth with DMDD subthreshold DMDD, and/or ADHD) and healthy volunteers. All subjects will have already been enrolled in 02-M-0021 or 01-M-0192.
• Enrolled in 02-M-0021.
• Aged 8-17 at the time of recruitment.
• Healthy Volunteer Children
• Enrolled in 02-M-0021 or 01-M-0192 as a healthy volunteer.
• Aged 8-17 at the time of recruitment.

You may not qualify if:

• An individual who has contraindications for scanning will be excluded.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Ellen Leibenluft, M.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2022
• First Posted: May 3, 2022
• Study Start: January 5, 2023
• Primary Completion: January 5, 2023
• Study Completion: January 5, 2023
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Starting six months after publication and ending five years later
• Access Criteria: All data will be available that are allowable based on IRB-approved procedures.(SqrRoot)

Locations

US (1)