Disruptive Mood Dysregulation DisorderNCT05357495
Characterization and Brain Mechanisms of Frustration in Youth With Severe Irritability or Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Affective Posner fMRI frustration induction task in people with Disruptive Mood Dysregulation Disorder and Attention Deficit Hyperactivity Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Disruptive Mood Dysregulation Disorder, Attention Deficit Hyperactivity Disorder, Normal Physiology
- What is being tested?
- Affective Posner fMRI frustration induction task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2023to 5 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- -An individual who has contraindications for scanning will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Characterization and Pathophysiology of Frustration in Pediatric Irritability
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.
Read more
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.
Read the detailed description
Study Description:
Participants in this study will be drawn from those enrolled in Protocol 02-M-0021 or 01-M-0192. This protocol uses detailed clinical phenotyping and a frustration induction task, coupled with pre- and post-frustration resting state scans, to study brain mechanisms mediating severe irritability in youth. The primary objective is to identify brain networks contributing to reconfiguration during and after frustration, and to test the ability of brain network metrics obtained using a frustration induction task to predict irritability. The secondary objective is to test whether these predictions are strengthened by the addition of structural connectivity measures and deeper clinical phenotyping.
Objectives:
Primary Objective:
To use multi-modal functional magnetic resonance imaging (fMRI), including a frustration induction task, coupled with resting state functional connectivity (rsFC) pre- and post-frustration, to elucidate neural mechanisms mediating frustration and how aberrant responses to frustration contribute to severe irritability in youth. Specifically, we will identify brain networks contributing to reconfiguration during and after frustration and test the ability of brain network metrics to predict irritability.
Secondary Objectives:
To test whether the prediction of irritability can be improved by the addition of structural brain connectivity measures obtained using diffusion tensor imaging (DTI), and clinical measures i.e., real-time, ecologically valid measures of mood and behavior obtained using ecological momentary assessment (EMA).
Endpoints:
Primary Endpoints:
Global efficiency (Eglob) of brain modules during resting state after frustration, which we hypothesize will predict irritability. Variance of information (VIn) measures, which we hypothesize will demonstrate that anterior DMN-temporal-limbic (aDMN-TL) and fronto-parietal (FP) modules make the largest contributions to network reconfiguration throughout frustration.
Secondary Endpoints:
Measures of structural connectivity obtained using DTI, and EMA measures of mood and behavior, which we hypothesize will improve the prediction of irritability.
- Conditions
- Disruptive Mood Dysregulation Disorder, Attention Deficit Hyperactivity Disorder, Normal Physiology
- Being tested
- Affective Posner fMRI frustration induction task
- Keywords
- Magnetic Resonance Imaging, Resting State, Task Based
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affective Posner fMRI frustration induction taskBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| frustration and control fMRI tasks | Experimental | all subjects complete one scanning session with frustration induction and one scanning session with the control task. Receives: Behavioral: Affective Posner fMRI frustration induction task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Remote digital phenotyping will be used to assess mood and behavior throughout the week following each of the two scanning sessions. These EMA measures will be included in a machine learning model to test whether their inclusion can improve the prediction of irritability ratings.
Measured: for one week after each of the two scanning sessions
Diffusion tensor imaging (DTI) metrics
Standard DTI metrics will be included in a machine learning model to test whether their inclusion can improve the prediction of irritability ratings.
Measured: during first scanning session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start5 Jan 2023
- Primary completion5 Jan 2023
- Study completion5 Jan 2023
Why it stopped: PI is retiring
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruptive Mood Dysregulation DisorderStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ellen Leibenluft, M.D., Principal investigator, National Institute of Mental Health (NIMH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05357495
- Sponsor's protocol ID
- 10000774
- Other IDs
- 000774-M
- Status last verified
- Jan 2023
- First submitted
- 29 Apr 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: .This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Pathophysiology of Frustration in Pediatric Irritability
- ClinicalTrials.gov ID
- NCT05357495
- Acronym / sponsor ID
- 10000774
- Conditions
- Disruptive Mood Dysregulation Disorder, Attention Deficit Hyperactivity Disorder, Normal Physiology
- Keywords
- Magnetic Resonance Imaging, Resting State, Task Based
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI is retiring
- Enrolment
- 0 participants (actual)
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 5 Jan 2023 (actual)
- Study completion
- 5 Jan 2023 (actual)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Description:
Participants in this study will be drawn from those enrolled in Protocol 02-M-0021 or 01-M-0192. This protocol uses detailed clinical phenotyping and a frustration induction task, coupled with pre- and post-frustration resting state scans, to study brain mechanisms mediating severe irritability in youth. The primary objective is to identify brain networks contributing to reconfiguration during and after frustration, and to test the ability of brain network metrics obtained using a frustration induction task to predict irritability. The secondary objective is to test whether these predictions are strengthened by the addition of structural connectivity measures and deeper clinical phenotyping.
Objectives:
Primary Objective:
To use multi-modal functional magnetic resonance imaging (fMRI), including a frustration induction task, coupled with resting state functional connectivity (rsFC) pre- and post-frustration, to elucidate neural mechanisms mediating frustration and how aberrant responses to frustration contribute to severe irritability in youth. Specifically, we will identify brain networks contributing to reconfiguration during and after frustration and test the ability of brain network metrics to predict irritability.
Secondary Objectives:
To test whether the prediction of irritability can be improved by the addition of structural brain connectivity measures obtained using diffusion tensor imaging (DTI), and clinical measures i.e., real-time, ecologically valid measures of mood and behavior obtained using ecological momentary assessment (EMA).
Endpoints:
Primary Endpoints:
Global efficiency (Eglob) of brain modules during resting state after frustration, which we hypothesize will predict irritability. Variance of information (VIn) measures, which we hypothesize will demonstrate that anterior DMN-temporal-limbic (aDMN-TL) and fronto-parietal (FP) modules make the largest contributions to network reconfiguration throughout frustration.
Secondary Endpoints:
Measures of structural connectivity obtained using DTI, and EMA measures of mood and behavior, which we hypothesize will improve the prediction of irritability.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| frustration and control fMRI tasks | Experimental | Behavioral: Affective Posner fMRI frustration induction taskall subjects complete one scanning session with frustration induction and one scanning session with the control task. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- -An individual who has contraindications for scanning will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Affective Posner fMRI frustration induction taskDuring 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. | Behavioural | frustration and control fMRI tasks |
Primary outcome
prediction of irritability ratings by global efficiency
Time frame: 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.
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
Variance of information (VIn) measures
Time frame: data are obtained throughout each of the two scanning sessions. The two scanning sessions will be 2-5 weeks apart.
VIn metric will be used to identify the brain modules making the largest contribution to network reconfiguration throughout frustration
2 secondary outcomes
ecological momentary assessment (EMA) measures
Time frame: for one week after each of the two scanning sessions
Diffusion tensor imaging (DTI) metrics
Time frame: during first scanning session
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. .This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Leibenluft, M.D. principal investigator
National Institute of Mental Health (NIMH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affective Posner fMRI frustration induction task in people with Disruptive Mood Dysregulation Disorder and Attention Deficit Hyperactivity Disorder, run by National Institute of Mental Health (NIMH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prediction of irritability ratings by global efficiency (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.