4.3 Article

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

期刊

JOURNAL OF ATTENTION DISORDERS
卷 18, 期 2, 页码 133-144

出版社

SAGE PUBLICATIONS INC
DOI: 10.1177/1087054712441969

关键词

ADHD; adults; modafinil; efficacy

资金

  1. Teva Pharmaceuticals Industries Ltd. [NCT000315276]

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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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