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Central Nervous System Stimulant

mixed amphetamine salts-extended release (MAS-XR) for Attention Deficit Hyperactivity Disorder (ADHD) (NERF Trial)

Phase 4
Waitlist Available
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and up to 12 weeks
Awards & highlights

NERF Trial Summary

This trial is testing the effects of MAS-XR on brain function in children with ADHD. The researchers will also look at whether MAS-XR increases or decreases the likelihood of developing problems like acting out.

Eligible Conditions
  • Attention Deficit Hyperactivity Disorder (ADHD)

NERF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Baseline-endpoint change in prefrontal-amygdala functional connectivity by fMRI.
Secondary outcome measures
Baseline-endpoint change in glutamate (Glu) and N-acetyl aspartate (NAA) concentrations in the prefrontal cortex (BA47) by 1H MRS.
Baseline-endpoint change in uncinate fasciculus white matter integrity by DTI

NERF Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: LR-MAS - Low-risk ADHD adolescentsExperimental Treatment1 Intervention
ADHD adolescents without any first or second degree-relatives with bipolar disorder. Low-risk ADHD adolescents (n=60) will receive treatment with open-label mixed amphetamine salts-extended release (MAS-XR), which is approved by the United States Food and Drug Administration (USFDA) for the treatment of ADHD and is a commonly prescribed psychostimulant medication for adolescents with ADHD.
Group II: HR-MAS - High-risk ADHD adolescentsExperimental Treatment1 Intervention
ADHD adolescents with a parent with bipolar disorder ("high-risk"). High-risk ADHD adolescents will be randomized to double-blind treatment with MAS-XR (n=60) or placebo (n=60). The subjects in this group will receive mixed amphetamine salts-extended release( MAS-XR), which is approved by the United States Food and Drug Administration (USFDA) for the treatment of ADHD and is a commonly prescribed psychostimulant medication for adolescents with ADHD.
Group III: HC (Healthy Controls)Active Control1 Intervention
Healthy subjects (n=60) will be recruited from the community and will not receive medication but will undergo MR scans at the same intervals to assess normal variability in imaging parameters between time points as well as to adjust and interpret comparisons within patients (i.e., whether patient values are changing toward or away from those of healthy adolescents). Neuroimaging evaluations will be performed at baseline and Week 12 (or termination).
Group IV: HR-P - High-risk ADHD on PlaceboPlacebo Group1 Intervention
ADHD adolescents with a parent with bipolar disorder ("high-risk"). High-risk ADHD adolescents will be randomized to double-blind treatment with MAS-XR (n=60) or placebo (n=60). Following initiation of treatment, the ADHD adolescents will have regularly scheduled visits during which symptom and tolerability ratings will be performed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
mixed amphetamine salts-extended release (MAS-XR)
2015
Completed Phase 4
~160

Find a Location

Who is running the clinical trial?

University of CincinnatiLead Sponsor
428 Previous Clinical Trials
634,241 Total Patients Enrolled
5 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
830 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
National Institute of Mental Health (NIMH)NIH
2,785 Previous Clinical Trials
2,689,603 Total Patients Enrolled
94 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
19,892 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Robert McNamara, PhDStudy DirectorUniversity of Cincinnati
5 Previous Clinical Trials
279 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Nevada
Ohio
Pennsylvania
Other
How old are they?
18 - 65
What site did they apply to?
University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Neuroimaging Study of Risk Factors for Adolescent Bipolar Disorder
Melissa Delbello 2015. "Neuroimaging Study of Risk Factors for Adolescent Bipolar Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02478788.
~16 spots leftby Apr 2025
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