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Neuroimaging Study of Risk Factors for Adolescent Bipolar Disorder (NERF)

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ClinicalTrials.gov Identifier: NCT02478788
Recruitment Status : Recruiting
First Posted : June 23, 2015
Last Update Posted : April 13, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Melissa Delbello, University of Cincinnati

Tracking Information
First Submitted Date  ICMJE June 15, 2015
First Posted Date  ICMJE June 23, 2015
Last Update Posted Date April 13, 2018
Actual Study Start Date  ICMJE November 2015
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2015)
Baseline-endpoint change in prefrontal-amygdala functional connectivity by fMRI. [ Time Frame: Baseline and up to 12 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02478788 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2015)
  • Baseline-endpoint change in uncinate fasciculus white matter integrity by DTI [ Time Frame: Baseline and up to 12 weeks ]
    Change in uncinate fasciculus white matter integrity will be determined by contrasting baseline and endpoint fractional anisotropy using diffusion tensor imaging (DTI).
  • Baseline-endpoint change in glutamate (Glu) and N-acetyl aspartate (NAA) concentrations in the prefrontal cortex (BA47) by 1H MRS. [ Time Frame: Baseline and up to 12 weeks ]
    This is a composite measure of change in right and left prefrontal cortex (BA47) Glu and NAA concentrations (mM). It will be determined by contrasting baseline and endpoint levels using proton magnetic resonance spectroscopy (1H MRS).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuroimaging Study of Risk Factors for Adolescent Bipolar Disorder
Official Title  ICMJE Neuroimaging Study of Risk Factors for Adolescent Bipolar Disorder
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.

Detailed Description A 12-week prospective study of two groups of adolescents (ages 10-18 years) with attention deficit/hyperactivity disorder (ADHD); 1) ADHD adolescents with a first degree relative with bipolar disorder ("high-risk") and 2) ADHD adolescents without any first or second degree-relatives with a mood 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Attention Deficit Hyperactivity Disorder
Intervention  ICMJE
  • 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.
    Other Name: AdderallXR
  • Drug: Placebo
    Pills with no medication in it
Study Arms  ICMJE
  • Experimental: LR-MAS - Low-risk ADHD adolescents
    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.
    Intervention: Drug: mixed amphetamine salts-extended release (MAS-XR)
  • Experimental: HR-MAS - High-risk ADHD adolescents
    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.
    Intervention: Drug: mixed amphetamine salts-extended release (MAS-XR)
  • Placebo Comparator: HR-P - High-risk ADHD on Placebo
    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.
    Intervention: Drug: Placebo
  • No Intervention: HC (Healthy Controls)
    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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2015)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Robert McNamara, PhD 513-558-5601 robert.mcnamara@uc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02478788
Other Study ID Numbers  ICMJE DelBello/McNamara Neuroimaging
R01MH097818-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Melissa Delbello, University of Cincinnati
Study Sponsor  ICMJE University of Cincinnati
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Study Director: Robert McNamara, PhD University of Cincinnati
PRS Account University of Cincinnati
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP