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

Abstract

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.

• Authors: P A Ahmann, F W Theye, R Berg, A J Linquist, A J Van Erem, L R Campbell
• Journal: Pediatrics (Pediatrics) Vol. 107 Issue 1 Pg. E10 (Jan 2001) ISSN: 1098-4275 [Electronic] United States
• PMID: 11134474 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Adderall
• Amphetamines
• Central Nervous System Stimulants

Topics

• Adolescent
• Amphetamines (adverse effects, therapeutic use)
• Attention Deficit Disorder with Hyperactivity (diagnosis, drug therapy)
• Central Nervous System Stimulants (therapeutic use)
• Child
• Double-Blind Method
• Female
• Humans
• Likelihood Functions
• Male
• Prospective Studies
• Treatment Outcome