To Evaluate the Safety and Metabolic Profile of Vyvanse for the Treatment of ADHD in Euthymic Adults With Bipolar I/II Disorder
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.
Attention Deficit/Hyperactivity Disorder
Drug: lisdexamfetamine dimesylate
|Study Design:||Time Perspective: Prospective|
- Metabolic parameters [ Time Frame: Screening (Week -1) to Endpoint (Week 4); Completed weekly on all 6 visits ] [ Designated as safety issue: No ]Weight; BMI; Waist circumference
- ADHD-RS [ Time Frame: Baseline (Week 0) to Endpoint (Week 4); completed weekly on 5 visits ] [ Designated as safety issue: No ]Measure of ADHD symptoms
- CAARS [ Time Frame: Baseline (Week 0) to Endpoint (Week 4); completed weekly on 5 visits ] [ Designated as safety issue: No ]Measure of ADHD symptoms
- CGI-BP [ Time Frame: Baseline (Week 0) to Endpoint (Week 4); Completed weekly on all 6 visits ] [ Designated as safety issue: Yes ]
- Q-LES-Q [ Time Frame: Baseline (Week 0) and Endpoint (Week 4); Completed on 2 visits ] [ Designated as safety issue: No ]Quality of Life
- AAQoL [ Time Frame: Baseline (Week 0), Week 2, Endpoint (Week 4); Completed on 3 visits ] [ Designated as safety issue: No ]Quality of Life
- Metabolic Peptidergic systems [ Time Frame: Baseline (Week 0) and Endpoint (Week 4); Completed on 2 visits ] [ Designated as safety issue: No ]Insulin; Resistin; Ghrelin; Leptin; Adiponectin
|Study Start Date:||October 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
This is an open-label study which means that all study participants will be taking active study medication, Vyvanse.
Drug: lisdexamfetamine dimesylate
Dosage form: Capsules; Dosage strength: 30-70mg/day, flexible dosing; Duration: 4 weeks
Other Name: Vyvanse
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263548
|Mood Disorders Psychopharmacology Unit|
|Toronto, Ontario, Canada, M5T 2S8|