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Background: Attention-deficit/hyperactivity disorder (ADHD) is a common and mostly chronic mental health condition that affects children, adolescents, and adults. Stimulants and atomoxetine are first-line agents for the treatment of ADHD. Despite the impressive track record of stimulants in the treatment of ADHD, they fail in 25% of patients due to lack of efficacy or the emergence of unwanted side effects. Accordingly, this study carried out to compare efficacy and safety of duloxetine (a serotonin and norepinephrine reuptake inhibitor) and methylphenidate (a short acting stimulant) in the treatment of children with attention-deficit/hyperactivity disorder.
Methods: Twenty-four children diagnosed with ADHD participated in this 6 weeks open clinical trial. Patients were between 6 to 11 years old that had been referred to psychiatry clinic at Akhavan and Rofide Medical and Rehabilitation Center in Tehran from September 2012 to July 2014. Diagnosis was made by two child psychiatrist according to DSM-IV TR criteria. Thirteen patients received duloxetine and others received methylphenidate. Conner’ parent rating scale-revised-short form (CPRS-RS) and ADHD-rating scale (ADHD-RS) were used at the beginning and then each two weeks to assess efficacy of treatment. Routine laboratory tests and electrocardiogram (ECG) was carried out in the beginning and end of the trial.
Results: Twenty children with ADHD completed the study (Ten in methylphenidate and ten in duloxetine group). In both groups, scales of CPRS-RS and ADHD-RS were reduced from baseline to endpoint, but this reduction in methylphenidate group was significantly greater than duloxetine group (P= 0.000). The most common side effect was gastrointestinal problems in duloxetine group and anorexia in methylphenidate group. No serious side effects and no changes in laboratory and ECG indexes were seen in both groups.
Conclusion: Duloxetine is not efficacious as well as methylphenidate in treatment of children with ADHD. Although more research are needed to achieve more accurate results.
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