Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With ADHD and Autism
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03337646|
Recruitment Status : Not yet recruiting
First Posted : November 9, 2017
Last Update Posted : November 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder Autism Spectrum Disorder||Drug: Lisdexamfetamine Dimesylate||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Multi-Center Open Label|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center, Open Label, Evaluation of the Effect and Safety of Lisdexamfetamine in Children Aged 6-12 With Attention Deficit Hyperactivity Disorder and Autism Spectrum Disorder|
|Anticipated Study Start Date :||November 2017|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
U.S. FDA Resources
All participants will receive Lisdexamfetamine Dimesylate (LDX) at an optimized dose based on protocol
Drug: Lisdexamfetamine Dimesylate
Medication to treat ADHD
Other Name: Vyvanse
- ADHD Symptoms [ Time Frame: 12 weeks ]Physician rated scale ADHD IV-RS each item is scaled 1 to 3 with a total between 0 and 54
- Health Related Quality of Life [ Time Frame: 12 weeks ]Parent completed rating scale called Child Health and Illness Profile- Child Edition: Parent Report Form ( CHIP-CE-PRF) . This is a generic child health status questionnaire that comprehensively describes all aspects of child health that can be influenced by the health care and school systems. It includes subdomains of satisfaction, discomfort, resilience, risk avoidance, achievement, and disorders. The domains and subdomains were conceptually derived and generally supported by factor analysis. The majority of items assess frequency of behaviors or experiences. Most items use a five-point response format. When a recall period is used, it is typically the past 4 weeks. Scale scores are obtained by computing the average of the individual item responses, whether scoring the domain or subdomain (in the PRF). The scale scores are standardized with a mean of 50 and standard deviation of 10. Higher scores indicate better health.
- Executive Function [ Time Frame: 12 weeks ]The BRIEF-P is a 90 item parent completed questionnaire with a global executive composite score (GEC). GEC is reported as a t-score and a t-score of less than 65 is within normal limits
- Severity of illness [ Time Frame: 12 weeks ]The severity of illness using the Clinical Global Impression-severity of illness, a 7 point scale which is physician rated
- Improvement of Subjects [ Time Frame: 12 weeks ]The severity of illness using the Clinical Global Impression-improvement of illness, a 7 point scale which is physician rated To evaluate the change in functional impairment in subjects. A score of 1 indicates very much improved while a score of 7 indicates very much worse
- Safety-Adverse events [ Time Frame: 12 weeks ]Adverse events are recorded at every visit
- Safety - suicidality [ Time Frame: 12 weeks ]Using the Columbia-Suicide Severity Rating Scale the incidence of suicidal thoughts and actions are recorded. The C-SSRS (Posner et al. 2011; Posner et al. 2010) is a semi-structured interview that captures the occurrence, severity, and frequency of suicide-related thoughts and behaviours during the assessment period. The interview includes definitions and suggested questions to solicit the type of information needed to determine if a suicide-related thought or behaviour has occurred.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03337646
|Contact: Judy van Stralen, MDfirstname.lastname@example.org|
|Principal Investigator:||Judy van Stralen, MD||Center for Pediatric Excellence|