Abstract Details

Title A Prospective Open-label Trial of Long-Acting Liquid Methylphenidate for the Treatment of Attention Deficit/Hyperactivity Disorder in Intellectually Capable Adults with Autism Spectrum Disorder

Topic Child Neurology and Developmental Neurology

Presentation(s) P5 - Poster Session 5 (5:30 PM-6:30 PM)

Poster/Presentation
Number 7-044

Objective To assess the tolerability and efficacy of extended-release liquid methylphenidate hydrochloride for the treatment of ADHD in adults with high-functioning ASD.

Background ADHD is the most common psychiatric disorder recognized in youth and adults with ASD. Treating ADHD comorbid with ASD could improve morbidity and impairment in individuals with autism; however, lower tolerability to anti-ADHD medications has been noted in individuals with ASD.

Design/Methods A six-week open-label clinical trial was conducted on 15 adults (Age: 24.9 [19-35]) with high-functioning ASD and ADHD of at least moderate severity. Methylphenidate hydrochloride extended-release liquid formulation (MPH-ER) (brand name Quillivant XR [25mg/5mL]) was administered on a flexible titration schedule. Efficacy was assessed utilizing clinician-rated measures (Adult ADHD Investigator Symptom Report Scale [AISRS] and Clinical Global Impression Scale [CGI]) and a self-rated measure (Adult ADHD Self-Report Scale [ASRS]). The primary outcome criteria for response was ≥30% reduction in AISRS total score and CGI-ADHD-Improvement score ≤2. Tolerability was assessed through safety measures including vital signs and treatment emergent adverse events.

Results Six-week treatment with MPH-ER (mean dose at endpoint: 48.7) was associated with significant improvement in symptom severity of ADHD (AISRS: baseline: 36.7 ± 5.4, endpoint: 13.9 ± 8.5, mean reduction: 22.8 ± 8.8; ASRS: baseline: 41.1 ± 12.1, endpoint: 32.9 ± 13.9, mean reduction: 8.2 ± 15.3). Overall, 80 percent of participants met the primary outcome criteria for response. The MPH-ER was well tolerated and the reported adverse events (AEs) were transient and mild to moderate. AEs were experienced by 14 of 15 participants (93%). Most frequently noted adverse events (>10%) were headaches (40%), insomnia (20%), decreased appetite (20%), anxiety (13%), and difficulty falling asleep (13%). One participant terminated the trial due to treatment-limiting AEs.

Conclusions

Our findings suggest that MPH-ER formulation is very effective and well-tolerated in the treatment of ADHD in adults with high-functioning ASD.

Authors/Disclosures
PRESENTER	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
	No disclosure on file
Joseph Biederman, MD (Mass General Hospital)	No disclosure on file

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