Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response

Study Overview
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Brief Summary
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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.

Official Title
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Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Radiation: MRI


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylphenidate<br>Adult subjects (ages 18-45) receiving a Methylphenidate derivative medication | Radiation: MRI<br>* 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.<br>|
| Experimental: Amphetamine<br>Adult subjects (ages 18-45) receiving an Amphetamine derivative medication | Radiation: MRI<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADHD Clinical Global Impressions Scale - Severity (CGI-S) | The 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. | 6 months | 
| ADHD Clinical Global Impressions Scale - Improvement (CGI-I) | The 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Connectomic Variation Prediction of Medicine Response | Examine 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Methylphenidate, Amphetamine, Attention Deficit Hyperactivity Disorder, Treatment