Bipolar Disorder Clinical Trial
ADHD in the adult population is associated with several measures of harmful dysfunction. For
example, adult ADHD is associated with high rates of separation/divorce and never-married
status, lower educational attainment and occupational achievement, absenteeism,
presenteeism, and job termination, as well as decreased social function. Individuals with
adult ADHD are more likely than controls to have a comorbid diagnosis of bipolar disorder,
alcohol and substance abuse, as well as antisocial personality disorder.
Psychostimulants are the most frequently employed medications in the treatment of adult
ADHD. Several psychostimulants are Health Canada and US FDA-approved for the treatment of
ADHD symptoms in adulthood.
Hitherto, no trial has evaluated the safety and efficacy of a psychostimulant in the
treatment of ADHD symptomatology in adult individuals with bipolar disorder.
Vyvanse is the first prodrug stimulant indicated for the treatment of adult (and pediatric)
ADHD. Vyvanse is a therapeutically inactive molecule (i.e. prodrug). After oral ingestion,
lisdexamfetamine is converted to l-lysine, a naturally occurring essential amino acid, and
active d-amphetamine, which is responsible for the drug's activity. Vyvanse provides a
longer duration of effect consistent throughout the day with reduced potential for risk of
abuse. Vyvanse is generally well tolerated with an adverse event profile similar to other
psychostimulant medications. Available evidence indicates that in most treated subjects,
Vyvanse is weight-neutral and/or is associated with weight loss. Moreover, in some
individuals, it is associated with improvement in both glucose and lipid homeostasis.
The evaluation of safety/tolerability profiles as well as the effectiveness of
lisdexamfetamine in a "real-world" population has significant translational value.
n/a
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