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Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03153488
Recruitment Status : Recruiting
First Posted : May 15, 2017
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Joseph Biederman, MD, 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Radiation: MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. ADHD Clinical Global Impressions Scale - Severity (CGI-S) [ Time Frame: 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.

  2. ADHD Clinical Global Impressions Scale - Improvement (CGI-I) [ Time Frame: 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 :
  1. Connectomic Variation Prediction of Medicine Response [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153488


Contacts
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Contact: Elizabeth Noyes 617-724-2551 enoyes@partners.org
Contact: Alexa Pulli, BS 617-726-4651 apulli@partners.org

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Elizabeth Noyes    617-724-2511    enoyes@partners.org   
Principal Investigator: Joseph Biederman, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Massachusetts Institute of Technology
Investigators
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Principal Investigator: Joseph Biederman, MD Massachusetts General Hospital
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Responsible Party: Joseph Biederman, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03153488    
Other Study ID Numbers: 2017P000547
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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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
Keywords provided by Joseph Biederman, MD, Massachusetts General Hospital:
ADHD
Methylphenidate
Amphetamine
Attention Deficit Hyperactivity Disorder
Treatment
Additional relevant MeSH terms:
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Hyperkinesis
Disease
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases