Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism
Condition: Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorder
MeSH terms: Hyperkinesis; Autistic Disorder; Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 4

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).
    

Detailed description: 
      ADHD is the most common pediatric neurobiological condition affecting approximately five
      percent of the pediatric population (Faraone, Stephen V., Sergeant, J. et al. 2003; Feldman &
      Belanger 2009). ASD is being increasingly recognized as affecting a substantial amount of the
      pediatric population, with recent prevalence data showing 1 in 68 affected (U.S. Department
      of Health and Human Services 2010). Prior to the introduction of DSM-5, exclusion criteria
      precluded the diagnosis for ADHD when ASD was present (American Psychiatric Association
      2013). Studies have shown that 41%-71% of children with ASD also meet criteria for ADHD,
      meaning up to 1% of the population may have comorbid ADHD and ASD (Goldstein & Schewbach
      2004).

      With the official recognition of comorbidity, treatment of comorbid ADHD when ASD is also
      present has been increasingly recognized as an important strategy in decreasing ADHD
      symptoms, and improving executive functioning and quality of life of those affected. Studies
      have indicated that some of the medications (methylphenidate, guanfacine XR and atomoxetine)
      commonly used to treat ADHD are effective and safe when used in comorbid ADHD and ASD
      (Ornstein & Kollins 2012; Ghuman et al. 2009; Handen et al. 2000; Quintana et al. 1995; Posey
      et al. 2004; Scahill et al. 2015; M. et al. 2012). While amphetamine class compounds are
      amongst the first line of treatment in ADHD, the lack of studies in this population has
      discouraged their use in subjects with comorbid ADHD and ASD.

      The lack of safety and efficacy data is problematic as it limits therapeutic options for the
      population of subjects with ADHD and ASD. Amphetamines and methylphenidate medications are
      equally considered first line treatment options for ADHD (CADDRA 2011). Some subjects may
      preferentially respond to one group of medications over another, therefore it is important to
      have clear safety and efficacy data for both therapeutic options.

      A retrospective chart review of this population indicates that treatment is started with
      methylphenidate versus combined amphetamine/dextroamfetamine at a ratio of 2.78:1 (Stigler et
      al. 2004). Due to the availability of evidence of efficacy in this comorbid population,
      clinicians may choose to skip to what is considered a second line medication for ADHD
      symptomatology rather than using LDX (or another amphetamine-based ADHD medication such as
      dexedrine or Adderall XR) that may have a larger effect size for treating these symptoms.

      LDX has been shown to be an effective treatment for ADHD in subjects 6 and above. With long
      lasting effectiveness shown to last up to 14 hours, it could potentially improve ADHD
      symptoms and overall quality of life for children and adolescents with ADHD and ASD in home,
      school and after-school functioning.

      The purpose of this study is to evaluate the safety and efficacy of LDX in treating ADHD when
      ASD is co-morbid.
    

Intervention name(s): Lisdexamfetamine Dimesylate
Intervention type(s): Drug
Intervention description(s): Medication to treat ADHD
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Intervention model: Single Group Assignment
Intervention model description: Multi-Center Open Label
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vyvanse; executive function; safety