Question

Question: Does atomoxetine reduce symptoms of attention deficit/hyperactivity (ADHD) disorder in children with autism spectrum disorder (ASD) compared with placebo?

Patients: Ninety-seven children and adolescents aged between 6 and 17 years with a clinical diagnosis of ASD (confirmed using the Autism Diagnostic Interview revised) and concomitant ADHD symptoms (according to DSM-IV-TR criteria, confirmed using the ADHD Rating Scale, ADHD-RS). Exclusions: psychosis, bipolar disorder, substance abuse, serious medical illness, previous seizures, current use of psychoactive medications other than the study medication, intended start of inpatient treatment or structured psychotherapy, or weight <20 kg.

Setting: Nine child and adolescent psychiatry centres and other mental health institutions, the Netherlands; time period not stated.

Intervention: 1.2 mg/kg/day atomoxetine versus placebo for 8 weeks. Atomoxetine dose was titrated up to the fixed once-daily dose over 3 weeks (0.5 mg/kg/day first week, 0.8 mg/kg/day second week, 1.2 mg/kg/day third and subsequent weeks). Individuals who started inpatient treatment, structured psychotherapy or other psychoactive medications were discontinued from the study.

Outcomes: Primary outcome: change in ADHD-RS …