ARTICLES
Analog Classroom Assessment of a Once-Daily Mixed Amphetamine Formulation, SLI381 (ADDERALL XR), in Children With ADHD

https://doi.org/10.1097/01.CHI.0000046863.56865.FEGet rights and content

ABSTRACT

Objectives

This investigation was conducted primarily to assess the safety and efficacy of SLI381 (Adderall XR™), developed as a once-daily treatment for children with attention-deficit/hyperactivity disorder (ADHD). Secondary objectives included examination of the time course, pharmacokinetic, and pharmacodynamic properties of SLI381.

Method

This was a randomized, double-blind, crossover study of three doses of SLI381 (10, 20, and 30 mg), placebo, and an active control (Adderall® 10 mg) given once daily to 51 children with ADHD. Weekly assessments in an analog classroom setting included blind ratings of attention and deportment and a performance measure (math test) obtained every 1.5 hours over a 12-hour period.

Results

SLI381 was well tolerated. All active treatment conditions displayed significant time course effects and were superior to placebo in improving efficacy measures. Dose-dependent improvements were evident for SLI381. SLI381 20 and 30 mg and Adderall all showed rapid improvements by 1.5 hours, but only the SLI381 20- and 30-mg doses showed continued activity at 10.5 and 12 hours for classroom behavior and math test performance versus placebo.

Conclusions

These data provide support for the benefit of this novel, once-daily amphetamine preparation in the treatment of ADHD. The longer duration of action of SLI381 has the potential to simplify psychostimulant dosing, thus reducing dose diversion and eliminating the need for in-school administration. SLI381 appears to be a useful treatment option for many children with ADHD.

Section snippets

METHOD

The study was conducted at four academic sites under local university human subject protection committee approval. Subjects were recruited at the four sites through a combination of advertising and distribution of information about study participation at local outpatient clinics. All subjects provided written assent for study participation; parents provided written consent for their child's enrollment. Families were compensated $50 for participation in each all-day analog classroom day.

RESULTS

Fifty-one children were enrolled in the study. The mean age of the total sample was 9.5 (±1.9) years. The sample consisted of 44 boys and 7 girls. The subjects had a mean duration of prior psychostimulant medication treatment of 1.7 (±1.7) years. Of those children with a history of stimulant treatment at the time of study screening, 30 (59%) were receiving methylphenidate and 17 (33%) were receiving an amphetamine-containing medication. Demographics and other characteristics of the sample are

DISCUSSION

The goal of this investigation was to assess the efficacy, tolerability, and time course of response of SLI381 (Adderall XR), a new drug delivery system for d-, l-amphetamine salts as a treatment for children with ADHD. SLI381 at three doses (10, 20, and 30 mg q.d.) was compared with a positive control, immediate-release Adderall 10 mg q.d., and placebo, in a randomized, double-blind, crossover design, using an analog classroom procedure with measurements of behavior and classroom performance

REFERENCES (33)

  • JM Swanson et al.

    Analog classroom assessment of Adderall® in children with ADHD

    J Am Acad Child Adolesc Psychiatry

    (1998)
  • American Academy of Pediatrics et al.

    Clinical practice guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder

    Pediatrics

    (2001)
  • LE Arnold

    Methylphenidate versus amphetamine: a comparative review

  • LE Arnold et al.

    Methylphenidate vs. dextroamphetamine vs. caffeine in minimal brain dysfunction

    Arch Gen Psychiatry

    (1978)
  • RA Barkley

    Attention-Deficit Hyperactivity Disorder: A Handbook for Diagnosis and Treatment

    (1990)
  • RA Barkley

    The ecological validity of laboratory and analogue assessment methods of ADHD symptoms

    J Abnorm Child Psychol

    (1991)

    • Cited by (0)

    This study was supported by a grant from Shire Pharmaceutical Development Inc.

    View full text
    Copyright © 2001 The American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.