A randomized, double-blind, placebo-controlled study of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorder.
OBJECTIVE
To evaluate the efficacy and tolerability of modafinil in children and adolescents, ages 7 to 17, with attention-deficit/hyperactivity disorder (ADHD).


METHODS
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%).


CONCLUSIONS
Modafinil was well tolerated and reduced ADHD symptoms at school and home compared with placebo.
Greenhill
Laurence L
LL
Dr. Greenhill is with the New York State Psychiatric Institute, New York; Dr. Biederman is with the Department of Pediatric Psychopharmacology, Massachusetts General Hospital, Boston; Dr. Boellner is with the Neurology and Clinical Study Center, Little Rock, AR; Dr. Rugino is with Childrenapos;s Specialized Hospital, Mountainside, NJ; Dr. Sangal is with Clinical Neurophysiology Services, PC, Troy, MI; Drs. Earl and Jiang are with Cephalon, Inc., West Chester, PA; and Dr. Swanson is with the University of California at Irvine Child Development Center. Electronic address: larrylgreenhill@cs.com.
Biederman
Joseph
J
Dr. Greenhill is with the New York State Psychiatric Institute, New York; Dr. Biederman is with the Department of Pediatric Psychopharmacology, Massachusetts General Hospital, Boston; Dr. Boellner is with the Neurology and Clinical Study Center, Little Rock, AR; Dr. Rugino is with Childrenapos;s Specialized Hospital, Mountainside, NJ; Dr. Sangal is with Clinical Neurophysiology Services, PC, Troy, MI; Drs. Earl and Jiang are with Cephalon, Inc., West Chester, PA; and Dr. Swanson is with the University of California at Irvine Child Development Center.
Boellner
Samuel W
SW
Dr. Greenhill is with the New York State Psychiatric Institute, New York; Dr. Biederman is with the Department of Pediatric Psychopharmacology, Massachusetts General Hospital, Boston; Dr. Boellner is with the Neurology and Clinical Study Center, Little Rock, AR; Dr. Rugino is with Childrenapos;s Specialized Hospital, Mountainside, NJ; Dr. Sangal is with Clinical Neurophysiology Services, PC, Troy, MI; Drs. Earl and Jiang are with Cephalon, Inc., West Chester, PA; and Dr. Swanson is with the University of California at Irvine Child Development Center.
Rugino
Thomas A
TA
Dr. Greenhill is with the New York State Psychiatric Institute, New York; Dr. Biederman is with the Department of Pediatric Psychopharmacology, Massachusetts General Hospital, Boston; Dr. Boellner is with the Neurology and Clinical Study Center, Little Rock, AR; Dr. Rugino is with Childrenapos;s Specialized Hospital, Mountainside, NJ; Dr. Sangal is with Clinical Neurophysiology Services, PC, Troy, MI; Drs. Earl and Jiang are with Cephalon, Inc., West Chester, PA; and Dr. Swanson is with the University of California at Irvine Child Development Center.
Sangal
R Bart
RB
Dr. Greenhill is with the New York State Psychiatric Institute, New York; Dr. Biederman is with the Department of Pediatric Psychopharmacology, Massachusetts General Hospital, Boston; Dr. Boellner is with the Neurology and Clinical Study Center, Little Rock, AR; Dr. Rugino is with Childrenapos;s Specialized Hospital, Mountainside, NJ; Dr. Sangal is with Clinical Neurophysiology Services, PC, Troy, MI; Drs. Earl and Jiang are with Cephalon, Inc., West Chester, PA; and Dr. Swanson is with the University of California at Irvine Child Development Center.
Earl
Craig Q
CQ
Dr. Greenhill is with the New York State Psychiatric Institute, New York; Dr. Biederman is with the Department of Pediatric Psychopharmacology, Massachusetts General Hospital, Boston; Dr. Boellner is with the Neurology and Clinical Study Center, Little Rock, AR; Dr. Rugino is with Childrenapos;s Specialized Hospital, Mountainside, NJ; Dr. Sangal is with Clinical Neurophysiology Services, PC, Troy, MI; Drs. Earl and Jiang are with Cephalon, Inc., West Chester, PA; and Dr. Swanson is with the University of California at Irvine Child Development Center.
Jiang
John G
JG
Dr. Greenhill is with the New York State Psychiatric Institute, New York; Dr. Biederman is with the Department of Pediatric Psychopharmacology, Massachusetts General Hospital, Boston; Dr. Boellner is with the Neurology and Clinical Study Center, Little Rock, AR; Dr. Rugino is with Childrenapos;s Specialized Hospital, Mountainside, NJ; Dr. Sangal is with Clinical Neurophysiology Services, PC, Troy, MI; Drs. Earl and Jiang are with Cephalon, Inc., West Chester, PA; and Dr. Swanson is with the University of California at Irvine Child Development Center.
Swanson
James M
JM
Dr. Greenhill is with the New York State Psychiatric Institute, New York; Dr. Biederman is with the Department of Pediatric Psychopharmacology, Massachusetts General Hospital, Boston; Dr. Boellner is with the Neurology and Clinical Study Center, Little Rock, AR; Dr. Rugino is with Childrenapos;s Specialized Hospital, Mountainside, NJ; Dr. Sangal is with Clinical Neurophysiology Services, PC, Troy, MI; Drs. Earl and Jiang are with Cephalon, Inc., West Chester, PA; and Dr. Swanson is with the University of California at Irvine Child Development Center.
D000293:Adolescent; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy*; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000009:adverse effects; D000697:Central Nervous System Stimulants / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D000077408:Modafinil; D010342:Patient Acceptance of Health Care; D010552:Personality Assessment; D013607:Tablets; D016896:Treatment Outcome
D001559:Benzhydryl Compounds; D000697:Central Nervous System Stimulants; D013607:Tablets; D000077408:Modafinil