Modafinil Improves Symptoms of Attention-Deficit/Hyperactivity Disorder across Subtypes in Children and Adolescents
Received 12 June 2006; received in revised form 20 June 2007; accepted 27 July 2007. published online 25 October 2007.
Objective
This secondary analysis evaluated the efficacy of modafinil in children and adolescents by subtype of attention-deficit/hyperactivity disorder (ADHD) using pooled data from 3 double-blind, placebo-controlled studies.
Study design
The patients were boys and girls age 6 to 17 years. ADHD subtype diagnoses (ie, inattentive, hyperactive-impulsive, combined) were based on criteria published in the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Patients received modafinil (170 to 425 mg) or placebo once daily for 7 to 9 weeks. Efficacy assessment used the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) School and Home Versions, Clinical Global Impression of Improvement scale (CGI-I), and Conners’ Parent Rating Scale-Revised: Short Form (CPRS-R:S).
Results
A total of 638 patients received modafinil (n = 423) or placebo (n = 215). The inattentive, hyperactive-impulsive, and combined subtypes included 187 (30%), 27 (4%), and 403 (65%) patients, respectively. Modafinil (vs placebo) significantly improved mean total scores for the ADHD-RS-IV School and Home Versions for the inattentive (change from baseline: School, modafinil, −15.7, placebo, −7.1; Home, modafinil, −13.8, placebo, −5.9) and combined subtypes (School, −16.5 vs −8.8; Home, −15.7 vs −7.6). Modafinil was associated with greater improvements on the CGI-I and improved CPRS-R:S subscale scores in inattentive and combined subtypes.
Conclusions
Modafinil improved ADHD symptoms and behaviors in patients with the inattentive and combined subtypes as determined by teachers, investigators, and parents.
aFrom the Pediatric Psychopharmacology Unit, Massachusetts General Hospital, Boston, MA
bUniversity of Texas Health Science Center, San Antonio, TX.
Reprint requests: Joseph Biederman, MD, Massachusetts General Hospital, Pediatric Psychopharmacology Unit, Yawkey Center for Outpatient Care, YAW-6A-6900, 32 Fruit St., Boston, MA 02114.
The research detailed in this manuscript was funded by Cephalon, Inc.
1 Dr Biederman receives research support from the following sources: Shire, Eli Lilly, Pfizer, McNeil, Abbott, Bristol-Myers-Squibb, New River Pharmaceuticals, Cephalon, Janssen, Neurosearch, Stanley Medical Institute, Novartis, Lilly Foundation, Prechter Foundation, National Institutes of Mental Health, National Institute of Child Health and Human Development, and National Institute on Drug Abuse. Dr Biederman is a speaker for the following speakers’ bureaus: Shire, Lilly, McNeil, Cephalon, UCB Pharma, and Novartis. Dr Biederman is on the advisory board of the following pharmaceutical companies: Eli Lilly, Shire, McNeil, Janssen, Novartis, and Cephalon.
2 Dr Pliszka receives research support from Eli Lilly and Cephalon and is a speaker for speakers’ bureaus sponsored by Shire and McNeil.
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