A Randomized, Double-Blind, Placebo-Controlled Study of Modafinil Film-Coated Tablets in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder - 09/08/11
, JOSEPH BIEDERMAN, M.D., SAMUEL W. BOELLNER, M.D., THOMAS A. RUGINO, M.D., R. BART SANGAL, M.D., CRAIG Q. EARL, Ph.D., JOHN G. JIANG, Ph.D., JAMES M. SWANSON, Ph.D.ABSTRACT |
Objective |
To evaluate the efficacy and tolerability of modafinil in children and adolescents, ages 7 to 17, with attention-deficit/hyperactivity disorder (ADHD).
Method |
In this 9-week, double-blind, flexible-dose study, patients were randomized to once-daily modafinil (170-425 mg) or placebo. Assessments included ADHD Rating Scale-IV (ADHD-RS-IV) School and Home Versions and Clinical Global Impression of Improvement (CGI-I) scale.
Results |
Two hundred patients were randomized. Modafinil produced significant reductions in ADHD-RS-IV total scores at school (n = 128; mean change ± SD: −17.5 ± 13.1 points) compared with placebo (n = 66; −9.7 ± 10.3 points; p < .0001). Similarly, modafinil reduced ADHD-RS-IV total scores at home compared with placebo (−17.6 ± 13.3 versus −7.5 ± 11.8 points; p < .0001). Fifty-two percent of patients randomized to modafinil and 18% of those randomized to placebo met prestudy criteria for responder on the CGI-I (p < .0001). Randomization to modafinil was associated with significantly more insomnia, headache, decreased appetite, and weight loss than randomization to placebo, but discontinuation attributed to adverse events did not differ statistically between treatment groups (modafinil, 5%; placebo, 6%).
Conclusion |
Modafinil was well tolerated and reduced ADHD symptoms at school and home compared with placebo.
Le texte complet de cet article est disponible en PDF.Key Words : modafinil, modafinil film-coated tablets, attention-deficit/hyperactivity disorder, clinical trial
Plan
| 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. |
Vol 45 - N° 5
P. 503-511 - mai 2006 Retour au numéro
- Sleep Hygiene and Melatonin Treatment for Children and Adolescents With ADHD and Initial Insomnia
- MARGARET D. WEISS, MICHAEL B. WASDELL, MELISSA M. BOMBEN, KATHLEEN J. REA, ROGER D. FREEMAN
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