Neurobiological Basis of Response to Vyvanse in Adults With ADHD: an fMRI Study of Brain Activation
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: Lisdexamfetamine
Intervention description: Escalating stepped dose titration: 30, 50 or 70mg
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Attention Deficit Hyperactivity Disorder; ADHD; fMRI; Imaging; Vyvanse; Stimulant Medication; Treatment; Clinical Trial; Adult

Summary:

      The purpose of this study is to determine the effects of Vyvanse, an FDA approved medication
      used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD), on brain activity
      in adults with attention-deficit hyperactivity disorder (ADHD). Participants may qualify for
      participation in this study because they have ADHD and are willing to participate in two
      Functional Magnetic Resonance Imaging (fMRI) scans and receive Vyvanse for treatment of their
      symptoms. Another purpose of this study is to collect and bank samples of blood for research
      to examine how genes influence brain activation seen during the brain scans. The study also
      seeks to find out whether certain genes are related to ADHD. Participants' entire genetic
      makeup will not be determined from this sample.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary DSM-IV-TR diagnosis of adult ADHD (inattentive, hyperactive-impulsive or
             combined subtype), established via the ACDS v1.2.

          -  Must be between 18-55 years, inclusive.

          -  Provides written informed consent.

        Exclusion Criteria:

          -  Lifetime or current diagnosis of bipolar disorder, schizophrenia or schizoaffective
             disorder.

          -  Current diagnosis of comorbid major depressive disorder, anxiety disorder or dysthymia
             or any controlled (i.e. requires pharmacological treatment) comorbid diagnosis.
             Participants with uncontrolled depressive or anxiety disorders may participate if, in
             the opinion of the Principal Investigator, the disorder will not confound the results
             of efficacy or safety assessments, increase risk to the participant or lead to
             difficulty complying with the protocol.

          -  Meets current DSM-IV-TR criteria for alcohol or any non-alcohol substance abuse or
             dependence disorder.

          -  Have organic brain disease (such as dementia) or traumatic brain injury residua. Have
             a history of seizure disorder (other than febrile seizures) or participants who have
             taken (or are currently taking) anticonvulsants for seizure control.

          -  Females who are currently pregnant or breast feeding, and women of child-bearing
             potential who are not currently using an adequate form of birth control.

          -  Participants with clinically significant abnormalities in ECG results that are deemed
             exclusionary in the opinion of the Principal Investigator will not be allowed in the
             trial.

          -  Participants who work the night shift or another schedule that would preclude
             beginning the daily dose of study medication in the morning.

          -  Participants with a positive urine drug result at Screening.

          -  Medical conditions limiting participation in the study.

          -  Documented history of intolerance or non-responsivity to methylphenidate or
             amphetamines.

          -  Have a medical condition that would, in the opinion of the study physician, make
             participation medically hazardous.

          -  ADHD, Not Otherwise Specified

          -  History of surgery involving metal implants, metal fragments in the eyes, braces, or a
             pacemaker.