Trial reportJournal of child and adolescent psychopharmacology2017
Adverse Events of Atomoxetine in a Double-Blind Placebo-Controlled Study in Children with Autism.
Trial report in Journal of child and adolescent psychopharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD).The Cochrane database of systematic reviews · 2023Pooled it
- A 1.5-Year Follow-Up of Parent Training and Atomoxetine for Attention-Deficit/Hyperactivity Disorder Symptoms and Noncompliant/Disruptive Behavior in Autism.Journal of child and adolescent psychopharmacology · 2018Trial
- Atomoxetine, Parent Training, and Their Effects on Sleep in Youth with Autism Spectrum Disorder and Attention-Deficit/Hyperactivity Disorder.Journal of child and adolescent psychopharmacology · 2018Trial
- Systematic review: Safety and efficacy of atomoxetine in children and adolescents with autism spectrum disorder.JCPP advances · 2026Article
- Children and Adolescents with Co-Occurring Attention-Deficit/Hyperactivity Disorder and Autism Spectrum Disorder: A Systematic Review of Multimodal Interventions.Journal of clinical medicine · 2025Review
- Growing evidence of pharmacotherapy effectiveness in managing attention-deficit/hyperactivity disorder in young children with or without autism spectrum disorder: a minireview.Frontiers in psychiatry · 2024Review
- Pharmacotherapy in autism spectrum disorders, including promising older drugs warranting trials.World journal of psychiatry · 2023Review
- Safety of 80 antidepressants, antipsychotics, anti-attention-deficit/hyperactivity medications and mood stabilizers in children and adolescents with psychiatric disorders: a large scale systematic meta-review of 78 adverse effects.World psychiatry : official journal of the World Psychiatric Association (WPA) · 2020Article
- Pharmacotherapy of ADHD in Adults With Autism Spectrum Disorder: Effectiveness and Side Effects.Journal of attention disorders · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveAttention-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.
methodsWe 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.
resultsATX 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.
conclusionsThis 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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