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Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response

Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03153488
Enrollment
60
Registered
2017-05-15
Start date
2018-07-01
Completion date
2023-12-01
Last updated
2022-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD, Methylphenidate, Amphetamine, Attention Deficit Hyperactivity Disorder, Treatment

Brief summary

This is a 6-month trial in adults to find out if certain neuromarkers can predict individual treatment response to stimulant medications for Attention Deficit Hyperactivity Disorder (ADHD). Males and females, ages 18-45, will complete an MRI scan at MIT prior to beginning medication for ADHD as determined by a treating clinician outside the context of this study.

Interventions

RADIATIONMRI

All participants will perform one MRI session before initiation of treatment. The imaging session will last about an hour including the structural and functional MRI portions. The subjects lie on a padded scanner couch in a dimly illuminated room, and wear foam earplugs to attenuate scanner sounds.

Sponsors

Massachusetts Institute of Technology
CollaboratorOTHER
Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* Male and female adults ages 18-55 * A diagnosis of DSM-V ADHD based on clinical assessment supported by the ADHD module of a structured diagnostic interview * Proficiency in English * Right-handed

Exclusion criteria

* Any contraindication for the use of a stimulant medication * Investigator and his/her immediate family (spouse, parent, child, grandparent, or grandchild) * Any contraindications for MRI examination (metallic implants, such as pacemakers, surgical aneurysm clips, or known metal fragments in the body) * Women who are currently pregnant or breastfeeding, as confirmed by a urine pregnancy test * Clinically significant abnormal baseline laboratory values, including systolic and diastolic blood pressure parameters above 140 and 90, respectively and resting heart rate outside 60-100 bpm

Design outcomes

Primary

MeasureTime frameDescription
ADHD Clinical Global Impressions Scale - Severity (CGI-S)6 monthsThe Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment.
ADHD Clinical Global Impressions Scale - Improvement (CGI-I)6 monthsThe Clinical Global Impression - Improvement scale (CGI-I) is a 7-point scale that requires the clinician to assess how the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention.

Secondary

MeasureTime frameDescription
Connectomic Variation Prediction of Medicine Response6 monthsExamine whether variation in baseline ADHD severity scores and functional connectivity and structural connectivity predict whether an individual ADHD patient will respond better to one of the other stimulant family treatment, both, or neither. An MRI will be completed prior to starting medication.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026