Mixed Amphetamine Salts Extended-Release in the Treatment of Adult ADHD: A Randomized, Controlled Trial
Abstract
Introduction: Attention-deficit/hyperactivity disorder (ADHD) is a serious neurobehavioral disorder of childhood onset that often persists into adolescence and adulthood. Functional impairments, underachievement, and difficult interpersonal relationships illustrate the need for effective treatment of ADHD through adulthood. Method: This prospective, multisite, randomized, double-blind, placebo-controlled, parallel-group, dose-escalation study was conducted to assess the efficacy, safety, and duration of action of mixed amphetamine salts extended-release (MAS XR) in adults with ADHD, combined type. Adults ≥ 18 years of age were given placebo or MAS XR 20, 40, or 60 mg/day for 4 weeks. The main outcome measures were the ADHD Rating Scale and Conners' Adult ADHD Rating Scale Short Version Self-Report (CAARS-S-S). Results: Two hundred fifty-five subjects were randomly assigned to treatment with MAS XR or placebo. MAS XR treatment was associated with statistically and clinically significant ADHD symptom reduction at endpoint; mean ADHD Rating Scale scores were 18.5 for the 20-mg group ( P =.001), 18.4 for the 40-mg group ( P <.001), and 18.5 for the 60-mg group ( P <.001). Adults with severe symptoms (ADHD Rating Scale score ≥32 at baseline) had significantly greater symptom reduction with the highest MAS XR dose (60 mg/day), however, this dose-response relationship was determined by post-hoc analysis. The mean MAS XR effect size was 0.8. Statistically significant ( P <.05) improvements in CAARS-S-S ADHD index scores occurred at 4- and 12-hours postdose for all MAS XR groups, indicating a 12-hour duration of effect. Symptoms improved within the first treatment week. Most adverse events reported were mild or moderate in intensity, arid the most commonly reported adverse events were consistent with the known profile of stimulant medications. Vital signs and electrocardiograms showed no clinically significant cardiovascular changes. Conclusion: These results suggest that MAS XR is safe and effective in adults with ADHD and controlled ADHD symptoms for up to 12 hours.
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In the United States, more than ten different stimulant preparations have been developed for treatment of ADHD, the most recent being long acting formulations of oros-methylphenidate, mixed amphetamine salts, dexmethylphenidate and lis-dexamphetamine.
“In the United States, more than ten different stimulant preparations have been developed for treatment of ADHD, the most recent being long acting formulations of oros-methylphenidate, mixed amphetamine salts, dexmethylphenidate and lis-dexamphetamine [265,287,288].”
From European consensus statement on diagnosis and treatment of adult ADHD: The European Network Adult ADHD (2010) · cites this paper as [288]
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- Authors
- Weisler, R. H., Biederman, J., Spencer, T. J., Wilens, T. E., Faraone, S. V., Chrisman, A. K., Read, S. C., & Tulloch, S. J.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- Venue
- CNS Spectrums
- Publisher
- Cambridge University Press (CUP)
- Published
- 2006-08
- Volume
- 11
- Issue
- 8
- Pages
- 625-639
- ISSN
- 1092-8529 (ISSN-L)
- 2165-6509
- OpenAlex
- W2159184227
- Cited by
- 158
- References
- 39
- Citations by year
- 2026: 1 · 2024: 7 · 2023: 2 · 2022: 3 · 2021: 2 · 2020: 4 · 2019: 4 · 2018: 5 · 2017: 8 · 2016: 4 · 2015: 4 · 2014: 9 · 2013: 5 · 2012: 11
- FWCI
- 11.24
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- CNS Spectrums (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Keywords
- adult ADHD, combined type ADHD, stimulant medication, dose-response relationship, duration of effect, ADHD symptom reduction, drug safety, ADHD Rating Scale
- MeSH terms
- Adolescent, Adult, Amphetamines, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Delayed-Action Preparations, Double-Blind Method, Female, Humans, Male, Middle Aged, Diagnostic and Statistical Manual of Mental Disorders
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