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
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.
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 DTIBaseline-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).
Eligibility
Minimum age: 13 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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
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