Attention Deficit Hyperactivity Disorder (ADHD) Prediction of Treatment Response
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- ADHD Clinical Global Impressions Scale - Improvement (CGI-I)
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Joseph Biederman, MD
Principal Investigator
Massachusetts General Hospital
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
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Connectomic Variation Prediction of Medicine Response(6 months)