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A Randomized, Double-blind, Placebo-Controlled Trial

Christopher Gillberg, MD, PhD; Hans Melander, MSc; Anne-Liis von Knorring, MD, PhD; Lars-Olof Janols, MD, PhD; Gunilla Thernlund, MD; Bruno Hägglöf, MD, PhD; Lena Eidevall-Wallin, MD; Peik Gustafsson, MD; Svenny Kopp, MD

Arch Gen Psychiatry. 1997;54(9):857-864.

Abstract
Background
We wanted to study the effects of amphetamine on symptoms of attention-deficit hyperactivity disorder (ADHD) over a longer period than has been reported in previous studies of central stimulants in this condition.

Methods
Sixty-two children, aged 6 to 11 years, meeting DSM-III-R symptom criteria for ADHD participated in a parallel-group design, randomized, double-blind, placebo-controlled study of amphetamine treatment. Treatment was not restricted to children with "pure" ADHD, ie, some had comorbid diagnoses. In the amphetamine group, children received active treatment for 15 months.

Results
Amphetamine was clearly superior to placebo in reducing inattention, hyperactivity, and other disruptive behavior problems and tended to lead to improved results on the Wechsler Intelligence Scale for Children—Revised. Treatment failure rate was considerably lower and time to treatment failure was longer in the amphetamine group. Adverse effects were few and relatively mild.

Conclusion
The results of this long-term, placebo-controlled study of the central stimulant amphetamine in the treatment of ADHD indicate that there are remaining positive effects of the drug 15 months after starting treatment.

Author Affiliations
From the Departments of Child and Adolescent Psychiatry, University of Göteborg, Göteborg (Drs Gillberg and Kopp), University of Uppsala, Uppsala (Drs von Knorring and Janols), University of Lund, Lund (Drs Thernlund, Eidevall-Wallin, and Gustafsson), University of Umeå, Umeå (Dr Hägglöf), and the Swedish Medical Products Agency, Uppsala (Mr Melander), Sweden.

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