Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response

Not Applicable

Active, not recruiting

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Radiation: MRI

• Registration Number: NCT03153488
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-11
• Study First Posted: 2017-05-15
• Study Start: 2018-07-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-22
• Last Update Posted: 2022-09-26
• Primary Completion: 2023-07-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylphenidate	MRI	Adult subjects (ages 18-45) receiving a Methylphenidate derivative medication
Amphetamine	MRI	Adult subjects (ages 18-45) receiving an Amphetamine derivative medication

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States