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To Evaluate the Safety and Metabolic Profile of Vyvanse for the Treatment of ADHD in Euthymic Adults With Bipolar I/II Disorder
This study is currently Recruiting
December 2010 By University Health Network, Toronto
First Recieved on December 14, 2010
Last Updated on December 17, 2010
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.
||Time Perspective: Prospective
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
This is an open-label study which means that all study participants will be taking active study medication, Vyvanse.
Dosage form: Capsules; Dosage strength: 30-70mg/day, flexible dosing; Duration: 4 weeks
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- Outpatient status
- Male or female subjects between the ages of 18 to 55 years, inclusive
- Primary diagnosis of Bipolar Disorder and ADHD according to criteria in the
Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) using the Mini
International Neuropsychiatric Interview.
- Agree to use reliable method of birth control
- YMRS score </= 12
- CGI-BP < 6
- Able and willing to provide a written informed consent
- Current Axis I primary psychiatric diagnosis other than Bipolar Disorder and ADHD
- Current Axis II psychiatric disorder of primary clinical focus
- Active alcohol as well as illicit or other substance abuse during the past 3 months
- Current clinically unstable medical condition.
- Inability to understand and engage in the process of informed consent.
- Inability to cooperate with study procedures.
- Presence of known allergies or hypersensitivity to lisdexamfetamine
- History of destabilization when exposed to psychostimulant medication
- Current high risk of suicide
- Current treatment with corticosteroids
- Electroconvulsive therapy in the last 1 year
- Current participation in a separate clinical research study involving an