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  • Title: 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.
    Author: Arnold VK, Feifel D, Earl CQ, Yang R, Adler LA.
    Journal: J Atten Disord; 2014 Feb; 18(2):133-44. PubMed ID: 22617860.
    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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