PEDIATRICS Vol. 107 No. 1 January 2001, p. e10

ELECTRONIC ARTICLE:
Placebo-Controlled Evaluation of Amphetamine MixtureDextroamphetamine Salts and Amphetamine Salts (Adderall): Efficacy Rate and Side Effects

Received Feb 10, 2000; accepted Sep 7, 2000.

Peter A. Ahmann^*, Fred W. Theye, Richard Berg^§, Ann J. Linquist^§, Alayne J. Van Erem, and Lois R. Campbell^*

From the Departments of ^* Neurology,  Neuropsychology, and  Pediatrics, Marshfield Clinic, and the Department of ^§ Clinical Research, Marshfield Medical Research Foundation, Marshfield, Wisconsin.

Objective.  The primary objective of this study was to determine the efficacy rate of Adderall in children newly diagnosed with attention-deficit/hyperactivity disorder (ADHD). A secondary objective was to address the severity of side effects associated with Adderall treatment in children with ADHD using the Barkley Side Effects Questionnaire (BSEQ).

Design.  Randomized, double-blind, placebo-controlled crossover trial.

Setting.  A large rural tertiary care clinic.

Patients.  Participants were prospectively recruited from children 5 to 18 years of age referred for academic and/or attention problems; 154 children who met the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria for ADHD were enrolled.

Interventions.  Two doses of Adderall (0.15 mg/kg/dose and 0.3 mg/kg/dose) were compared with placebo in separate 2-week trials. Participants received each dosage regimen twice daily for 7 consecutive days.

Measurements and Main Results.  Efficacy rates were determined by comparing Adderall with placebo during the low-dose crossover sequence and also during the high-dose crossover sequence. The criteria that defined a positive response to Adderall relative to placebo (with each patient serving as their own control) included an indication of response by at least 1 of 2 parent measures of children's behavior or at least 2 of 5 teacher measures of children's behavior. The Adderall efficacy rate was determined based on parent criteria alone, teacher criteria alone, and by a more stringent definition of response that required concurrence between parent and teacher criteria. The Adderall response rate in this study ranged from 59% when requiring concurrence between parent and teacher observers, to 82% when based on parent criteria alone. Overall, 137 of 154 participants (89%) showed a positive response by either the parent or teacher response criteria. Parents completed a modified version of the BSEQ during each week of the trial. Appetite, stomachaches, and insomnia were rated as worse by parents while children were receiving either dose of Adderall; headaches were rated as worse when children were receiving the higher dose of Adderall. Parents rated certain side effects, including staring/daydreaming, sadness, euphoria, and anxious/irritable, as worse during placebo regimens.

Conclusions.  We found that Adderall is highly efficacious in our population of youth diagnosed with ADHD. In addition, Adderall is well-tolerated with a side effect profile similar to that reported for other psychostimulants.  Key words:  attention-deficit/hyperactivity disorder, side effects, efficacy rate, Adderall.

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