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J Am Acad Child Adolesc Psychiatry. 2006 May;45(5):503-511. doi: 10.1097/01.chi.0000205709.63571.c9.

A randomized, double-blind, placebo-controlled study of modafinil film-coated tablets in children and adolescents with attention-deficit/hyperactivity disorder.

Author information

1
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.
2
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.

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.

[Indexed for MEDLINE]

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