Assessment the Efficacy of Atomoxetine in Autism Spectrum Disorders: A Randomized, Double-Blind, Placebo-Controlled Trial

Autism spectrum disorders (ASD) are early onset conditions characterized by significant impairment in social interaction and communication.
The purpose of this study was the assessment of Atomoxetine effectiveness and tolerability in the treatment of autistic features in patients with ASD.
A total of 44 children, aged 6 to 17 years, diagnosed with ASD, enrolled in a 8 week randomized clinical trial. The study conducted at the outpatient clinic of Ibne-sina hospital and Dr. Sheikh hospital affiliated to the Mashhad Medical University in Iran, between August 2015 to September 2016. Subjects were randomly allocated to Atomoxetine (0.5 to 1.2 mg/kg/day) plus risperidone or Placebo plus risperidone. The primary outcome was assessed by the childhood autism rating scale (CARS) and clinical global impression (CGI). Patients were evaluated at baseline, 4 weeks and 8 weeks after the administration of the drug. Mixed ANOVA test is used for the outcome of evaluation. The clinical trial registration number is: IRCT2016022826802N1.
Atomoxetine augmentation comparison to placebo augmentation showed significant improvement in global impression and severity index in CGI, and also in total score of CARS and 7 subscales of CARS including relationship to people, emotional response, body use, listening response, fear and nervousness, nonverbal communication, and activity level (all P value ≤ 0.05). The most common adverse effects of Atomoxetine were mood change, irritability, and GI disturbance.
The results showed that Atomoxetine add-on therapy may be effective in symptoms of ASD while adverse effects tend to subside. The authors suggest further studies for clarifying this conclusion.