Journal of the American Academy of Child & Adolescent Psychiatry
ARTICLESA Randomized, Double-Blind, Placebo-Controlled Study of Modafinil Film-Coated Tablets in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder
Section snippets
Patients
Eligible patients met the following inclusion criteria: 6 to 17 years of age, inclusive; the National Institute of Mental Health Diagnostic Interview Schedule for Children, Fourth Edition (DISC-IV) was used to establish the patients' diagnosis of ADHD using the full DSM-IV diagnostic criteria (American Psychiatric Association, 1994, Shaffer et al., 2000);Clinical Global Impression of Severity of Illness (CGI-S) rating of 4 or higher (moderately ill or worse) (Guy, 1976); weight and height
Patients and Dosing
A total of 200 patients were randomized; 131 received modafinil film-coated tablets and 67 received placebo (2 patients were not treated; Fig. 1). Seventy percent of patients completed the study, and discontinuation rates were higher in the placebo group (modafinil, 25%; placebo, 39%), with the majority of cases in both groups discontinuing because of a lack of efficacy. A total of 57 patients in the safety analysis set discontinued from the study (31 in the modafinil group and 26 in the
DISCUSSION
In this 9-week, double-blind, placebo-controlled study, modafinil film-coated tablets significantly improved ADHD symptoms compared with placebo on the ADHD-RS-IV School and Home Versions. Modafinilapos;s moderate effect size (0.60-0.78 SD) is similar to that of atomoxetine (Michelson et al., 2004), but smaller than methylphenidate (Greenhill et al., 2001). Taking the active drug was associated with improvements in inattention, hyperactivity, and impulsivity. Significantly more patients who
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Modafinil for the treatment of attention-deficit/hyperactivity disorder: A meta-analysis
2017, Journal of Psychiatric ResearchCitation Excerpt :It is known to act on multiple areas of the ascending arousal and attention systems to increase frontal cortical activity (Lin et al., 1996). Numerous randomized clinical trials (Biederman et al., 2005; Greenhill et al., 2006) and open label studies (Boellner et al., 2006; Rugino and Copley, 2001) have shown that modafinil could be an effective and safe treatment option in ADHD. A post hoc analysis of data consisted of 3 randomized, double-blind, placebo-controlled trials (RCTs) further demonstrated that modafinil improved symptoms of ADHD compared with placebo (Wigal et al., 2006).
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2013, NeuropharmacologyCitation Excerpt :Modafinil is an unusual stimulant with enigmatic pharmacology (see reviews by Minzenberg and Carter, 2008; Heal et al., 2012a). Although its clinical development as a treatment for ADHD was terminated due to safety concerns, modafinil has been shown unequivocally to improve symptoms in children and adolescents with ADHD in several, randomised, double-blind, placebo-controlled, clinical trials (Biederman et al., 2006; Swanson et al., 2006; Greenhill et al., 2006). Modafinil has a C-IV classification in the USA, but it is not a CD in the UK.
Statistical expert: John G. Jiang, Ph.D.
The authors acknowledge V. Arnold (Memphis, TN), L. Montgomery-Barefield (Birmingham, AL), M. Chandler (Chapel Hill, NC), R. Dean (Danville, IN), J. Ferguson (Salt Lake City, UT), J. Lee (Charlotte, NC), A. Levine (Boulder, CO), R. Lipetz (Spring Valley, CA), A. Padilla (Miami Beach, FL), R. Northam (Norfolk, VA), J. Pahl (Oklahoma City, OK), R. Reichler (Seattle, WA), E. Sarkis (Gainesville, FL), H. Schub (Atlanta, GA), M. Molina (Hialeah, FL), and ePharma Learning Inc. (Conshohocken, PA).
Disclosure: Dr. Greenhill receives research support from Eli Lilly and Co., Novartis Pharmaceuticals, and Shire; and he is a consultant for Novartis, Janssen Pharmaceutica, McNeil Consumer & Specialty Pharmaceuticals, and Pfizer. Dr. Biederman receives research support from Abbott Laboratories, Bristol-Myers Squibb, Cephalon, Eli Lilly, Janssen, McNeil, NeuroSearch, New River Pharmaceuticals, Pfizer, and Shire; and he serves on speakers' bureaus for Cephalon, Eli Lilly, McNeil, and Shire, and is on advisory boards for Cephalon, Eli Lilly, Janssen, McNeil, Novartis, and Shire. Dr. Boellneris an investigator for Celltech, New River Pharmaceuticals, Novartis, and Shire. Dr. Rugino receives research support from Cephalon and is on speakers' bureaus for Cephalon and Novartis. Dr. Sangal receives research support from Cephalon, Eli Lilly, Merck, Organon, and Sanofi-Aventis. Drs. Earl and Jiangare employees of Cephalon. Dr. Swanson receives research support from, serves on the speakers' bureaus for, and is a consultant to ALZA, Celgene, Celltech, Cephalon, Eli Lilly, Janssen, McNeil, Novartis, and Shire; he is also a consultant for Targacept.