Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism
Status:
Recruiting
Trial end date:
2021-10-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the effect and safety of Lisdexamfetamine dimesylate
(Vyvanse®) in the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children
and adolescents with ADHD and comorbid Autism Spectrum Disorder (ASD). This would be a novel
study as there is no known safety or efficacy data for amphetamine based medications in this
population. In addition, although health related quality of life and executive function are
known to improve with the treatment of lisdexamfetamine dimesylate in the ADHD population
(Banaschewski 2013; Findling 2009; Turgay 2010), it has not been shown in the co-morbid ADHD
and ASD population. ADHD is the most common pediatric neurobiological condition affecting
approximately five percent of the pediatric population (Feldman 2009). ASD is being
increasingly recognized as affecting a substantial amount of the pediatric population, with
recent prevalence data showing 1 in 68 affected (Baio, 2014). Prior to the introduction of
DSM-5 (APA, 2013), exclusion criteria precluded the diagnosis of ADHD when ASD was present.
Studies have shown that 41%-71% of children with ASD also meet criteria for ADHD (Goldstein
2004, Sturm 2004,Yoshida 2004, Gadow 2006). This means that up to 1% of the population may
have co-morbid ADHD and ASD. With the official recognition of this comorbidity, treatment of
comorbid ADHD when ASD is also present has been increasingly recognized as an important
strategy in improving executive functioning and quality of life in those affected. Studies
have indicated that some of the medications commonly used to treat ADHD, are effective and
safe when used in comorbid ADHD and ASD. At this time, there have been well designed studies
demonstrating safety and efficacy for methylphenidate (Ghuman et al. 2009; Handen et al.
2000; Quintana et al. 1995; RUPP 2005), guanfacine XR (Posey 2004; Scahill 2015), and
atomoxetine (Arnold 2006; Harfterkamp 2012).