Sponsor study identifier
Secondary identifiers
interventional
33
1 country
1
Study Start
November 5, 2019
Actual (reported)Primary Completion
August 8, 2023
Actual (reported)Study Completion
August 8, 2023
Actual (reported)Childhood ADHD and comorbid oppositional defiant disorder (ODD) and conduct disorder (CD) are considered risk factors for subsequent substance abuse, and youth with both ADHD and ODD/CD are at greatest risk. However, the effects of treatment of ADHD with stimulant medications such as methylphenidate (MPH) and mixed amphetamine salts (MAS) on risk for substance abuse are poorly understood. The study team propose to use fMRI to study the effects of extended release mixed amphetamine salts (MAS-XR) in drug-naïve youth 7-12 years at low risk (i.e., ADHD only) and high risk (i.e., ADHD + ODD/CD) for substance abuse on the brain reward system, to better understand the potential impact of these medications on an aspect of brain functioning which is thought to underlie vulnerability to substance abuse.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 8, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 5, 2019
Actual (reported)November 18, 2019
Actual (reported)November 20, 2019
Actual (reported)August 8, 2023
Actual (reported)August 8, 2023
Actual (reported)August 29, 2024
Actual (reported)Change in fMRI Measure
Bold activation change within the reward system. The contrasts in blood-oxygenation levels (BOLD) in regions of interest (ROIs).
baseline and 3 weeks post intervention
ADHD Rating Score (ADHD RS)
Pretreatment, baseline and Post-Treatment, average 2 weeks
Total Dose of MAS-XR
average 2 weeks
dosage = start at 0.25-0.50mg/kg, adjusted as necessary pills by mouth
3 weeks of Adderall
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Jeffrey Newcorn, MD
Icahn School of Medicine at Mount Sinai
Iliyan Ivanov, MD
Icahn School of Medicine at Mount Sinai
33 participants (actual enrollment reported by the registry).
First Submitted
November 18, 2019
First Posted
November 20, 2019
Study Start
November 5, 2019
Change in Clinical Global Impression - Improvement (CGI-I)
baseline and post treatment, average 2 weeks
Contact the study team to confirm eligibility.
Primary Completion
August 8, 2023
Actual (reported)Study Completion
August 8, 2023
Actual (reported)Last Updated
August 29, 2024
Results First Posted
August 29, 2024
Record last verified: 2024-08
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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