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Neuroimaging Study of Risk Factors for Adolescent Bipolar Disorder

NCT02478788 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2023-09-21

No results posted yet for this study

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.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

mixed amphetamine salts-extended release (MAS-XR)

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.

DRUG

Placebo

Pills with no medication in it

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Robert McNamara, PhD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2022-08-31
Completion
2022-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02478788 on ClinicalTrials.gov