Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03153488

Collaborator

Massachusetts Institute of Technology (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Radiation: MRI	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response

Actual Study Start Date :

Jul 1, 2018

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

ADHD Clinical Global Impressions Scale - Severity (CGI-S) [6 months]
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.
ADHD Clinical Global Impressions Scale - Improvement (CGI-I) [6 months]
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.

Secondary Outcome Measures

Connectomic Variation Prediction of Medicine Response [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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