A 9-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With ADHD
Abstract
Objective This study evaluated the efficacy and tolerability of modafinil at a range of doses, versus placebo, in alleviating symptoms of ADHD in adults. Method Adult patients with ADHD were randomized in 1:1:1:1:1 fashion to double-blind treatment with modafinil 255, 340, 425, or 510 mg daily or placebo for 9 weeks. The primary efficacy outcome was the change from baseline at final visit in the Adult ADHD Investigator Symptom Rating Scale (AISRS) total score. Results A total of 338 patients were enrolled, of whom 330 received at least 1 dose of study medication (modafinil or placebo). No statistically significant difference in the AISRS total score was observed at final visit between any modafinil group and placebo; however, some observations among patients who completed the trial may warrant further investigation. Conclusion Modafinil was reasonably tolerated but did not demonstrate a benefit on ADHD symptoms in adults.
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Modafinil shows promise as a treatment for ADHD.
“Modafinil, which inhibits dopamine and norepinephrine transporters and decreases ϒ-aminobutyric acid also shows promise as a treatment for ADHD (131).”
From Emotion Dysregulation in Attention Deficit Hyperactivity Disorder (2014) · cites this paper as [131]
Modafinil inhibits dopamine and norepinephrine transporters and decreases Υ-aminobutyric acid.
“Modafinil, which inhibits dopamine and norepinephrine transporters and decreases ϒ-aminobutyric acid also shows promise as a treatment for ADHD (131).”
From Emotion Dysregulation in Attention Deficit Hyperactivity Disorder (2014) · cites this paper as [131]
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Emotion Dysregulation in Attention Deficit Hyperactivity Disorder
Shaw, P., Stringaris, A., Nigg, J., & Leibenluft, E. (2014) · American Journal of Psychiatry · doi:10.1176/appi.ajp.2013.13070966 · Cited by 1,232 · see citing works
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Self-citation
- Authors
- Arnold, V. K., Feifel, D., Earl, C. Q., Yang, R., & Adler, L. A.
- Affiliations
- University of Tennessee Health Science Center (US)
- University of California San Diego (US)
- Teva Pharmaceuticals (United States) (US)
- VA NY Harbor Healthcare System (US)
- Venue
- Journal of Attention Disorders
- Publisher
- SAGE Publications
- Published
- 2012-05-22
- Volume
- 18
- Issue
- 2
- Pages
- 133-144
- ISSN
- 1087-0547 (ISSN-L)
- 1557-1246
- OpenAlex
- W2097773777
- Cited by
- 48
- References
- 8
- Citations by year
- 2026: 1 · 2025: 1 · 2024: 5 · 2023: 2 · 2022: 6 · 2021: 5 · 2020: 3 · 2019: 4 · 2018: 4 · 2017: 5 · 2016: 2 · 2015: 3 · 2014: 5 · 2013: 2
- FWCI
- 2.27
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Attention Disorders (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Teva Pharmaceutical Industries
- School of Medicine, New York University
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Life Sciences › Neuroscience › Cognitive Neuroscience › Neuroethics, Human Enhancement, Biomedical Innovations
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Keywords
- modafinil, adult ADHD, ADHD symptom severity, dose-finding, efficacy, tolerability, placebo comparison, stimulant pharmacotherapy
- MeSH terms
- Modafinil, Adult, Aged, Attention Deficit Disorder with Hyperactivity, Benzhydryl Compounds, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Time Factors, United States, Treatment Outcome, Young Adult, Wakefulness-Promoting Agents
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