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(PSYCHIATRIC TIMES)- The American Academy of Child and Adolescent Psychiatry Practic Parameter for the Assessment and Treatment of Children and Adolescents with Attention-Deficit/Hyperactivity Disorder1 (ADHD) recommends that initial psychopharmacological treatment consist of an FDA-approved medication. Agents in this category include stimulants (dextroamphetamine, methylphenidate, mixed salts amphetamine) and atomoxetine.

The clinician and the patient’s family must decide whether to initiate pharmacological treatment with a stimulant or atomoxetine. The largest study to date compared responses to atomoxetine and osmotic-release oral methylphenidate and may help to guide medication selection.2 Youths aged 6 to 16 years with any subtype of ADHD participated in the study. Comorbid bipolar disorder, pervasive developmental disorder, psychotic illness, anxiety disorders, and tic disorders were exclusionary criteria. Patients with other comorbid psychiatric disorders, including major depressive disorder, were allowed to participate if ADHD was the primary diagnosis.

The acute phase of the study was a double-blind, placebo-controlled, 6-week trial. Patients were randomized to receive 0.8 to 1.8 mg/kg/d of atomoxetine (n = 222), 18 to 54 mg/kg/d of osmotic-release methylphenidate (n = 220), or placebo (n = 74). The mean final dosage of atomoxetine was 1.45 mg/kg/d, or 53 mg/d; the mean final dosage of osmotic-release methylphenidate was 1.16 mg/kg/d, or 39.9 mg/d.

Response was defined as at least a 40% decrease in the ADHD Rating Scale-IV total score. After 6 weeks, 56% of patients responded to osmotic-release methylphenidate and 45% responded to atomoxetine; both responses were significantly superior to the 25% who responded to placebo.

The number needed to treat was 3 for osmotic-release methylphenidate and 5 for atomoxetine. Osmotic-release methylphenidate was significantly superior to atomoxetine. Effect size was higher for osmotic-release methylphenidate (0.8) than for atomoxetine (0.6).

Completion rates were similar across treatment groups, as were discontinuation rates from adverse events. Adverse effects were higher in the medication treatment groups than in the placebo group. Decreased appetite occurred significantly more in the medicated patients. Insomnia was more common in methylphenidate-treated patients than in atomoxetine-treated patients, and somnolence was more common in atomoxetine recipients than in methylphenidate recipients.

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