Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response

NCT03153488 | Unknown FDA Device

• 1 other identifier: 2017P000547
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Connectomic Variation Prediction of Medicine Response

  6 months

Study Arms (2)

Methylphenidate

EXPERIMENTAL

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

Radiation: MRI

Amphetamine

EXPERIMENTAL

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

Radiation: MRI

Interventions

MRI 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; Methylphenidate

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Massachusetts Institute of Technology: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Joseph Biederman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 15, 2017
• Study Start: July 1, 2018
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 26, 2022

Record last verified: 2022-09

Locations

US (1)