Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03393390 |
| Other study ID # |
HUM00088188 |
| Secondary ID |
5R01MH107741 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 17, 2016 |
| Est. completion date |
September 2019 |
Study information
| Verified date |
April 2022 |
| Source |
University of Michigan |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to learn more about the functioning of particular types of
regions of the brain, specifically, those related to externalizing disorders such as
Attention Deficit Hyperactivity Disorder (ADHD), Oppositional Defiance Disorder (ODD), and
Conduct Disorder (CD). Brain function of children and adolescents with externalizing
disorders such as ADHD, ODD, and CD will be compared to the brain function of those without.
Functional Magnetic Resonance Imaging (fMRI) will be used to monitor brain activity at work
and at resting states.
Description:
The goal of this research proposes to take a developmental neuroimaging approach to
elucidating brain mechanisms that lead to distinct forms of impulsivity in youth with
externalizing disorders, including attention-deficit/hyperactivity disorder (ADHD),
oppositional defiant disorder (ODD), and conduct disorder (CD). Roughly 12-15% of youth
suffer from at least one of these disorders (many of them have more than one) and they go on
to experience serious adverse outcomes over the course of their lifetimes including increased
rates of substance abuse, violence and criminality, maladjustment, and suicide. The absence
of a biological, and in particular a neurodevelopmental, understanding of the pathophysiology
of distinct kinds of impulsivity has been a major barrier to improving clinical care for
impulsive youth; it has hindered efforts at building better nosology, earlier and more
reliable diagnosis, and more effective treatments.
The NIMH Research Domain Criteria (RDoC) Initiative encourages clinical scientists to no
longer think in terms of single categorical diagnoses (whose boundaries may in fact be drawn
incorrectly), but rather to identify disorder-spanning constructs. Inspired by the RDoC
Initiative, our research aims to delineate the neural mechanisms of distinct forms of
impulsivity in youth from a transdiagnostic perspective that spans the three main
externalizing disorders, ADHD, CD, and ODD, as well as across subtypes of these disorders
(e.g., ADHD inattentive, hyperactive/impulsive, and combined types). More specifically, the
study aims to develop a new class of imaging-based biomarkers for specific forms of
impulsivity-markers that are rooted in aberrant brain maturation patterns.
Developing neuroimaging markers of impulsivity could have a number of important clinical
impacts. For example, these markers could provide a basis for more objective diagnosis,
facilitate earlier diagnosis, catalyze the development of new treatments, and help to guide
the selection of treatments.
For this study, 270 youth subjects will be recruited, 135 with at least one externalizing
disorder and 135 matched controls, between the ages of 6-18 . All participants will receive
the following: 1) a comprehensive clinical/neurological assessment to quantify impulsivity
symptoms; and 2) an fMRI session (structural, diffusion tensor imaging, resting, and task).
Three cohorts are recruited: childhood (6-9 years; n=90), early adolescence (10-13 years;
n=90), and middle adolescence (14-18; n=90).
The main aim of the study is to use imaging results to generate normative maturational curves
for each component in the brain's regulatory control architecture using a multi-level linear
mixed effects model. Multivariate models that predict types of impulsivity based on component
expression will then be constructed.
