Back to resultsAttention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Methylphenidate, Amphetamine, Attention Deficit Hyperactivity Disorder, Treatment
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Methylphenidate
Amphetamine
Arm Description
Adult subjects (ages 18-45) receiving a Methylphenidate derivative medication
Adult subjects (ages 18-45) receiving an Amphetamine derivative medication
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03153488
First Posted
May 11, 2017
Last Updated
September 22, 2022
Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT03153488
Brief Title
Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response
Official Title
Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Massachusetts Institute of Technology
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Methylphenidate, Amphetamine, Attention Deficit Hyperactivity Disorder, Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methylphenidate
Arm Type
Experimental
Arm Description
Adult subjects (ages 18-45) receiving a Methylphenidate derivative medication
Arm Title
Amphetamine
Arm Type
Experimental
Arm Description
Adult subjects (ages 18-45) receiving an Amphetamine derivative medication
Intervention Type
Radiation
Intervention Name(s)
MRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
ADHD Clinical Global Impressions Scale - Severity (CGI-S)
Description
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.
Time Frame
6 months
Title
ADHD Clinical Global Impressions Scale - Improvement (CGI-I)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Connectomic Variation Prediction of Medicine Response
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Biederman, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response
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