Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response

NCT ID: NCT03153488

Last Updated: 2022-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2023-12-01

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.

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Methylphenidate

Adult subjects (ages 18-45) receiving a Methylphenidate derivative medication

Group Type: EXPERIMENTAL

MRI

Intervention Type: RADIATION

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.

Amphetamine

Adult subjects (ages 18-45) receiving an Amphetamine derivative medication

Group Type: EXPERIMENTAL

MRI

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts Institute of Technology

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joseph Biederman, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Biederman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2017P000547

Identifier Type: -

Identifier Source: org_study_id