| Abstract | OBJECTIVE: This randomized, double-blind, placebo-controlled study assessed the efficacy and tolerability of several modafinil dosing regimens in children with attention-deficit/hyperactivity disorder (ADHD) to determine whether modafinil can be given once daily in pediatric ADHD. METHOD: Children and adolescents (age range, 6-13 years) (N = 248) with DSM-IV-defined ADHD were enrolled in a 4-week, double-blind, placebo-controlled study, conducted February-May 2002. The group was assigned to receive oral (100-mg tablets) modafinil 300 mg once daily (300 mg in the morning followed by placebo at midday), modafinil 300 mg as a divided dose (100/200 mg or 200/100 mg), or matching placebo. In children weighing > or = 30 kg, a higher dose of 400 mg (200/200 mg) was evaluated. Efficacy measures included the teacher-rated School Version and clinician-rated Home Version of the ADHD Rating Scale-IV and the parent-completed Conners' ADHD/DSM-IV Scales. RESULTS: 223 children completed the study. Those who received modafinil 300 mg once daily showed a significantly greater improvement (change from baseline) than those who received placebo in symptoms of ADHD across all rating scales and subscales (all p < .05). Divided 300-mg doses of modafinil provided some significant but inconsistent improvements in ADHD symptoms. In children weighing > or = 30 kg, modafinil 400 mg (200/200 mg) was significantly superior to placebo on clinician- and parent-completed scales (all p < .05). Insomnia was the only adverse event to occur with significantly greater frequency in a modafinil group (200/100) than in the placebo group (14% vs. 2%) (p = .03). CONCLUSION: Modafinil significantly improved ADHD symptoms in children. Once-daily dosing (300 mg) provided the most consistent improvement in symptoms. All dosing regimens of modafinil were well tolerated. |
| Authors | Joseph Biederman, James M Swanson, Sharon B Wigal, Samuel W Boellner, Craig Q Earl, Frank A Lopez, Modafinil ADHD Study Group
(Affiliation: Department of Pediatric Psychopharmacology, Massachusetts General Hospital, Boston 02114, USA. jbiederman at partners.org)
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| Journal | The Journal of clinical psychiatry
(J Clin Psychiatry)
Vol. 67
Issue 5
Pg. 727-35
(May 2006)
ISSN: 0160-6689 United States |
| PMID | 16841622
(Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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| Chemical References |
- Benzhydryl Compounds
- Central Nervous System Stimulants
- Placebos
- modafinil
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| Topics |
- Adolescent
- Age Factors
- Attention Deficit Disorder with Hyperactivity
(diagnosis, drug therapy, psychology)
- Benzhydryl Compounds
(administration & dosage, therapeutic use)
- Body Weight
- Central Nervous System Stimulants
(administration & dosage, therapeutic use)
- Child
- Diagnostic and Statistical Manual of Mental Disorders
- Dose-Response Relationship, Drug
- Double-Blind Method
- Drug Administration Schedule
- Female
- Humans
- Male
- Placebos
- Psychiatric Status Rating Scales
- Treatment Outcome
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