Journal
JOURNAL OF CHILD AND ADOLESCENT PSYCHOPHARMACOLOGY
Volume 27, Issue 8, Pages 708-714Publisher
MARY ANN LIEBERT, INC
DOI: 10.1089/cap.2016.0187
Keywords
atomoxetine; parent training; ADHD; adverse events; autism spectrum disorder
Categories
Funding
- National Institute of Mental Health [1R01MH079080-01A2]
- University of Pittsburgh [5R01MH079082-05]
- University of Rochester [R01 MH083247]
- Eli Lilly and Company
- University of Rochester CTSA [UL1 RR024160]
- Ohio State University CTSA from the National Center for Research Resources [UL1TR001070]
- National Center for Advancing Translational Sciences of the National Institutes of Health
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Objective: Attention-deficit/hyperactivity disorder (ADHD) symptoms, including inattention and over activity, occur in approximately one-third of children with autism spectrum disorder (ASD). We describe the rate and duration of adverse events in a randomized controlled trial of atomoxetine (ATX) and parent training (PT) for ADHD symptoms and noncompliance in children with ASD. Methods: We conducted a 10-week, double-blind, 2x2 trial of ATX and PT with 128 children (ages 5-14) randomized to ATX alone, ATX+PT, placebo+PT, or placebo alone. For 6 weeks, ATX (or placebo) doses were clinically adjusted to a maximum of 1.8mg/(kgday) and maintained for an additional 4 weeks. An average of seven PT sessions were conducted in the two PT arms. Adverse events (AEs) were assessed through parent ratings of common symptoms on a seven-point Likert severity scale and through direct interviews with study medical staff. Results: ATX was associated with decreased appetite and fatigue, but was otherwise well tolerated. Most reported AEs lasted 4 weeks or less. Unlike reports with typically developing (TD) children, there were no concerns with QTc changes or suicidal ideation. Conclusions: This study extends the findings of previous studies of ATX in ASD by documenting that the type of AEs was similar to that of TD children, with no significant safety concerns.
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