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Double-blind, placebo-controlled study of single-dose amphetamine formulations in ADHD
R S James1, W S Sharp, T M Bastain
1Child Psychiatry Branch, National Institute of Mental Health, Bethesda, MD, USA.
Insights
Adderall and dextroamphetamine sulfate effectively treat ADHD. While immediate-release forms offer quicker effects, dextroamphetamine Spansules provide longer-lasting symptom control for children with ADHD.
Area of Science:
- Pharmacology
- Neuroscience
- Pediatrics
Background:
- Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder.
- Pharmacological interventions are a cornerstone of ADHD management.
- Understanding the comparative efficacy and duration of different stimulant formulations is crucial for optimizing treatment.
Purpose of the Study:
- To compare the efficacy and time course of single morning doses of Adderall, extended-release dextroamphetamine sulfate (dextroamphetamine Spansules), and immediate-release dextroamphetamine sulfate.
- To evaluate the duration of action for different stimulant formulations in children with ADHD.
Main Methods:
- A randomized, double-blind, crossover study involving 35 children diagnosed with ADHD, combined type.
- Participants received Adderall, immediate-release dextroamphetamine, dextroamphetamine Spansules, and placebo.
- Efficacy was assessed using behavior ratings, locomotor activity measurements, and academic performance over 8 weeks.
Main Results:
- All three stimulant medications demonstrated significant efficacy compared to placebo across most measures.
- Dextroamphetamine Spansules showed less robust morning effects compared to Adderall but provided sustained benefits lasting 3–6 hours longer.
- While behavior and activity improvements lasted up to 12 hours for all drugs, only Spansules significantly improved math performance at 4 hours post-dosing.
Conclusions:
- Immediate-release amphetamines exhibit an earlier onset of therapeutic effects.
- Dextroamphetamine Spansules offer more sustained effects, impacting a broader range of outcome measures.
- The findings suggest formulation-dependent differences in the efficacy and duration of stimulant treatment for ADHD.
Objective:
To compare the efficacy and time course of single morning doses of Adderall, extended-release, and immediate-release dextroamphetamine sulfate.
Method:
Thirty-five children with attention-deficit/hyperactivity disorder, combined type, were given Adderall, immediate-release dextroamphetamine, dextroamphetamine Spansules, and placebo in a randomized, double-blind, crossover study. Behavior ratings, locomotor activity measurements, and academic measures were obtained over a period of 8 weeks.
Results:
All three drugs exhibited robust efficacy versus placebo on nearly all measures. The effects of dextroamphetamine Spansules were less robust in the morning, particularly compared with Adderall, but they lasted 3 to 6 hours longer, depending on the measure. Although parent behavior ratings and locomotor activity showed improvements up to 12 hours after single doses of all three drugs, the number of math problems attempted and completed correctly 4 hours after dosing were only robustly increased by Spansules.
Conclusions:
Both immediate-release amphetamines demonstrated earlier onset of effects, but dextroamphetamine Spansules showed more sustained effects that were present on a wider range of measures.
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Diagnostic Criteria and Symptoms
To diagnose ADHD, symptoms must manifest before age 12 and be evident across multiple settings.