Placebo-controlled evaluation of amphetamine mixture-dextroamphetamine salts and amphetamine salts (Adderall): efficacy rate and side effects.
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).


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


METHODS
A large rural tertiary care clinic.


METHODS
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.


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.
Ahmann
P A
PA
Department of Neurology, Marshfield Clinic, Wisconsin, USA.
Theye
F W
FW
Berg
R
R
Linquist
A J
AJ
Van Erem
A J
AJ
Campbell
L R
LR
D000293:Adolescent; D000662:Amphetamines / Q000009:adverse effects / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016013:Likelihood Functions; D008297:Male; D011446:Prospective Studies; D016896:Treatment Outcome
C090411:Adderall; D000662:Amphetamines; D000697:Central Nervous System Stimulants