Atomoxetine and Parent Training for Children With Autism and Attention-Deficit/Hyperactivity Disorder: A 24-Week Extension Study

Abstract

Objective We previously reported a 2×2 randomized clinical trial of individual and combined treatment with atomoxetine (ATX) and parent training (PT) for attention-deficit/hyperactivity disorder (ADHD) symptoms and behavioral noncompliance in 128 children with autism spectrum disorder, ages 5–14 years. We now describe a 24-week extension of treatment responders and non-responders. Method One-hundred seventeen participants from the acute trial (91%) entered the extension; 84 of these were in two subgroups: (1) “treatment responders” (n=43) from all four groups in the acute trial, seen monthly for 24 weeks, and (2) “placebo nonresponders” (n=41), treated with open-label ATX for 10 weeks. Participants originally assigned to PT continued in PT during the extension; the remainder served as controls. Primary outcome measures were parent-rated Swanson, Nolan and Pelham ADHD scale and Home Situations Questionnaire. Results Sixty percent (26/43) of treatment responders in the acute trial, including 68% of responders originally assigned to ATX, still met response criteria at the end of extension. The response rate of placebo nonresponders treated with 10-week open-label ATX was 37% (15/41), similar to the acute trial. Children receiving open-label ATX+PT were significantly more likely to be ADHD responders (53% vs 23%) and noncompliance responders (58% vs 14%) than those receiving open-label ATX alone. Conclusion Most ATX responders maintained their responses during the extension. PT combined with ATX in the open-label trial appeared to improve ADHD and noncompliance outcomes more than ATX alone.

Atomoxetine for attention deficit hyperactivity disorder in children and adolescents with autism: A systematic review and meta‐analysis

“…Initial responders continued to show sustained improvement in ADHD symptoms. Also, about a third of patients who were non‐responders to placebo responded to atomoxetine in the open label extension study period of 6 months [Smith et al, ]. This extension study aimed at the combined effect of Parent Training and Atomoxetine on Non‐compliant behavior of children with ASD and ADHD.…”

Autism spectrum disorder: Consensus guidelines on assessment, treatment and research from the British Association for Psychopharmacology

“…Atomoxetine, (both alone and combined with PT) significantly reduced ADHD symptoms (Handen et al, 2015). The authors conducted a 24-week extension study demonstrating that atomoxetine combined with PT was superior at reducing ADHD symptoms than atomoxetine alone (Smith et al, 2016). The effect sizes reported in the atomoxetine studies (0.59-0.98) are similar to the effect size reported for methylphenidate in children with ASD (0.67) (Research Units on Pediatric Psychopharmacology Autism Network, 2005), suggesting equivalent efficacy.…”

Clinical effects of Repetitive Transcranial Magnetic Stimulation Combined with Atomoxetine in the Treatment of Attention Deficit Hyperactivity Disorder

“…It has been reported that ATX or rTMS in combination with the behavior training had a better therapeutic effect when compared with the single method, but there are some reports showing no obvious advantage. 41,42 However, further in-depth research may need to increase sample size and optimize the treatment parameters.…”