Atomoxetine Versus Combination of Methylphenidate Plus Fluoxetine for Management of Anxiety Disorders in ADHD Children: A Randomized Clinical Trial

Background: Attention-deficit/hyperactivity disorder (ADHD) is the most common psychiatric disorder in childhood. Concurrent anxiety disorders have turned into a challenging issue for psychiatrists. Numerous medications have been applied with controversial responses. Objectives: The current study aimed to compare the efficacy of the combination of methylphenidate (MPH) and fluoxetine (FLX) versus atomoxetine (ATX) in the symptoms and function of ADHD children with concurrent anxiety disorders. Methods: The current randomized clinical was conducted on 76 outpatient children with concurrent ADHD and anxiety disorder within 2020 - 2021. The patients were divided into two equal groups. The first group was treated with MPH (5 mg twice daily) plus FLX (10 - 20 mg daily); nevertheless, the second group received ATX with a dose of 1.4 mg/kg. The Conner’s Parents Rating Scale (CPRS), Screen for Child Anxiety Related Emotional Disorders (SCARED), and Children’s Anxiety Impact Scale-Child (CAIS-C) were applied to assess anxiety at the baseline and 1 month and 4 months after the interventions. Results: The mean age of the studied population was 9.26 ± 1.92 years (range: 6 - 12 years), and 46 subjects (57.89%) were male. The significant trends of improvement in both groups, regardless of the interventions in the assessments of all the scales, were noted (P 0.001 for all the scales); however, the comparison of the groups revealed no differences in the CPRS (P = 0.397), SACRED (P = 0.663), and CAIS-C (P = 0.683). Conclusions: Based on the findings of this study, as ATX alone was as effective as MPH plus FLX for controlling anxiety disorders among ADHD children, ATX is preferred to apply fewer daily medications.