Neuroimaging Study of Risk Factors for Adolescent Bipolar Disorder

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Cincinnati
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Amphetamine

Criteria

Inclusion Criteria:

• 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).

Inclusion criteria for 'high-risk' and 'low-risk' ADHD subjects :

• 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

• No lifetime exposure to mood stabilizers or antipsychotic medications

• No concomitant use of any psychotropic medication other than study medications during study participation

• No history of intolerance, hypersensitivity, or non-response to MAS-XR

• No comorbid mood, anxiety, conduct, eating or psychotic disorder that in the opinion of the primary investigator is the current and primary focus of treatment. No Tourette's disorder, chronic tic disorder, or autism spectrum disorder.

• No clinically significant ECG or blood pressure abnormalities

• No family history of sudden death or ventricular arrhythmia