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Neuroimaging Study of Risk Factors for Adolescent Bipolar Disorder

Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Attention Deficit Hyperactivity Disorder

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

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: University of Cincinnati

Official(s) and/or principal investigator(s):
Robert McNamara, PhD, Study Director, Affiliation: University of Cincinnati

Overall contact:
Robert McNamara, PhD, Phone: 513-558-5601, Email: robert.mcnamara@uc.edu


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.

Clinical Details

Official title: Neuroimaging Study of Risk Factors for Adolescent Bipolar Disorder

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)

Primary outcome: Baseline-endpoint change in prefrontal-amygdala functional connectivity by fMRI.

Secondary outcome:

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

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

Detailed description: A 12-week prospective study of two groups of adolescents (ages 13-17 years) with attention deficit/hyperactivity disorder (ADHD); 1) ADHD adolescents with a parent with bipolar disorder ("high-risk") and 2) ADHD adolescents without any first or second degree-relatives with bipolar disorder ("low-risk"). Patients will be evaluated using diagnostic interviews and symptom ratings, will receive neuroimaging scans (fMRI, DTI, 1H MRS), and will then be assigned to treatment. 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. 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. Healthy subjects (n=60) will be recruited from the community and will not receive medication but will undergo magnetic resonance imaging (MRI) 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 (fMRI, DTI,1H MRS) evaluations will be performed at baseline and Week 12 (or termination).


Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): Both.


Inclusion Criteria:

- Ages 13-17 years old

- Tanner stage III-V

- 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 parent 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).

- No lifetime DSM-5 Axis I disorder (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

- Less than 3 months cumulative lifetime exposure to psychostimulants or other ADHD

medications and none in the year 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, Tourette's

disorder, chronic tic disorder, or pervasive developmental disorder.

- No clinically significant ECG or blood pressure abnormalities

- No family history of sudden death or ventricular arrhythmia

Locations and Contacts

Robert McNamara, PhD, Phone: 513-558-5601, Email: robert.mcnamara@uc.edu

University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience, Cincinnati, Ohio 45219, United States; Not yet recruiting
Robert K McNamara, PhD, Phone: 513-558-5601, Email: robert.mcnamara@uc.edu
Robert K McNamara, PhD, Principal Investigator
Melissa P DelBello, MD, MS, Principal Investigator
Additional Information

Starting date: July 2015
Last updated: June 18, 2015

Page last updated: August 20, 2015

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