Dataset Information

Adverse Events of Atomoxetine in a Double-Blind Placebo-Controlled Study in Children with Autism.

ABSTRACT: 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, 2?×?2 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 1.8?mg/(kg·day) 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.

SUBMITTER: Tumuluru RV

PROVIDER: S-EPMC5651962 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Adverse Events of Atomoxetine in a Double-Blind Placebo-Controlled Study in Children with Autism.

Tumuluru Rameshwari V RV Corbett-Dick Patricia P Aman Michael G MG Smith Tristram T Arnold L Eugene LE Pan Xueliang X Buchan-Page Kristin A KA Brown Nicole V NV Ryan Melissa M MM Hyman Susan L SL Hellings Jessica J Williams Craig C Hollway Jill A JA Lecavalier Luc L Rice Robert R RR McAuliffe-Bellin Sarah S Handen Benjamin L BL

Journal of child and adolescent psychopharmacology 20170516 8

<h4>Objective</h4>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.<h4>Methods</h4>We conducted a 10-week, double-blind, 2 × 2 trial of ATX and PT with 128 children (ages 5-14) ran ...[more]

PMID: 28509573

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Dataset Information

Adverse Events of Atomoxetine in a Double-Blind Placebo-Controlled Study in Children with Autism.

Publications

Adverse Events of Atomoxetine in a Double-Blind Placebo-Controlled Study in Children with Autism.

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