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

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.

• Authors: Laurence L Greenhill, Joseph Biederman, Samuel W Boellner, Thomas A Rugino, R Bart Sangal, Craig Q Earl, John G Jiang, James M Swanson
• Journal: Journal of the American Academy of Child and Adolescent Psychiatry (J Am Acad Child Adolesc Psychiatry) Vol. 45 Issue 5 Pg. 503-511 (May 2006) ISSN: 0890-8567 [Print] United States
• PMID: 16601402 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Benzhydryl Compounds
• Central Nervous System Stimulants
• Tablets
• Modafinil

Topics

• Adolescent
• Attention Deficit Disorder with Hyperactivity (diagnosis, drug therapy)
• Benzhydryl Compounds (administration & dosage, adverse effects)
• Central Nervous System Stimulants (administration & dosage, adverse effects)
• Child
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Humans
• Male
• Modafinil
• Patient Acceptance of Health Care
• Personality Assessment
• Tablets
• Treatment Outcome