Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Radiation: MRI

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Massachusetts Institute of Technology

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 15, 2017

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 22, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Treatment; ADHD; Attention Deficit Hyperactivity Disorder; Methylphenidate; Amphetamine
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: 2017P000547

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes