NCT02478788

Brief Summary

The main purpose of this study is to see the affects of the study medication called mixed amphetamine salts-extended release (MAS-XR) on brain function by taking brain pictures. The researchers also want to see if MAS-XR makes your child more or less likely to develop problems like acting out (i.e. periods of irritability, agitation, aggression). MAS-XR is approved by the United States Food and Drug Administration (FDA) to treat attention deficit hyperactivity disorder (ADHD) in adults, children and adolescents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

6.8 years

First QC Date

June 15, 2015

Last Update Submit

September 19, 2023

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD

Outcome Measures

Primary Outcomes (1)

  • Baseline-endpoint change in prefrontal-amygdala functional connectivity by fMRI.

    Using functional magnetic resonance imaging (fMRI), change in prefrontal-amygdala functional connectivity will be determined by contrasting baseline and endpoint blood oxygen level-dependent (BOLD) activity in the amygdala and prefrontal cortex (BA47) during performance of the CPT-END task, and determining the prefrontal-amygdala interrelationship using a seed-region (amygdala) based functional connectivity analysis.

    Baseline and up to 12 weeks

Secondary Outcomes (2)

  • Baseline-endpoint change in uncinate fasciculus white matter integrity by DTI

    Baseline and up to 12 weeks

  • Baseline-endpoint change in glutamate (Glu) and N-acetyl aspartate (NAA) concentrations in the prefrontal cortex (BA47) by 1H MRS.

    Baseline and up to 12 weeks

Study Arms (4)

LR-MAS - Low-risk ADHD adolescents

EXPERIMENTAL

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.

Drug: mixed amphetamine salts-extended release (MAS-XR)

HR-MAS - High-risk ADHD adolescents

EXPERIMENTAL

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.

Drug: mixed amphetamine salts-extended release (MAS-XR)

HR-P - High-risk ADHD on Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

HC (Healthy Controls)

NO 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).

Interventions

mixed amphetamine salts-extended release (MAS-XR)DRUG

MAS-XR is a psychostimulant medication composed of amphetamine and dextroamphetamine, has been systematically studied in adolescents with ADHD, and is FDA-approved for the treatment of ADHD in adolescents.

Also known as: AdderallXR
HR-MAS - High-risk ADHD adolescentsLR-MAS - Low-risk ADHD adolescents
PlaceboDRUG

Pills with no medication in it

HR-P - High-risk ADHD on Placebo

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages 10-18years old
  • If female, not pregnant
  • Fluent in English
  • No contraindication to an MRI scan (e.g., braces or claustrophobia)
  • An IQ \> 80
  • No unstable or major medical or neurological illness
  • No lifetime DSM-5 substance use disorder
  • Lives \<100 miles from the University of Cincinnati
  • Provision of written informed consent/assent
  • At least one biological first degree relative with bipolar I disorder ('high-risk' only)
  • No first- or second-degree relative with a mood or psychotic disorder ('low-risk' and healthy controls only) with the exception of late onset depressive disorders.
  • No lifetime DSM-5 Axis I disorder (other than specific phobias, healthy controls only).
  • No medications with CNS effects within 5 half-lives from baseline MR scan (healthy controls only).
  • Meets DSM-5 criteria for ADHD, inattentive, hyperactive/impulsive, or combined type
  • No exposure to psychostimulants or ADHD medications in the 3 months prior to baseline
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience

Cincinnati, Ohio, 45219, United States

Location

Related Publications (1)

  • Qin K, Pan N, Lei D, Zhu Z, Tallman MJ, Patino LR, Gong Q, Sweeney JA, DelBello MP, McNamara RK. Different Changes in Brain Functional Networks Following 12-Week Psychostimulant Treatment in Attention-Deficit/Hyperactivity Disorder Youth With and Without Familial Risk for Bipolar I Disorder. J Am Acad Child Adolesc Psychiatry. 2025 Jul 23:S0890-8567(25)00751-8. doi: 10.1016/j.jaac.2025.07.421. Online ahead of print.

    PMID: 40712681DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Robert McNamara, PhD

    University of Cincinnati

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Academic Medical Director

Study Record Dates

First Submitted

June 15, 2015

First Posted

June 23, 2015

Study Start

November 1, 2015

Primary Completion

August 1, 2022

Study Completion

December 1, 2022

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations

US(1)