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| ERIC #: | EJ697184 |
| Title: | Long-Term Tolerability and Effectiveness of Once-Daily Mixed Amphetamine Salts (Adderall XR) in Children with ADHD |
| Authors: | McGough, James J.; Biederman, Joseph; Wigal, Sharon B.; Lopez, Frank A.; McCracken, James T.; Spencer, Thomas; Zhang, Yuxin; Tulloch, Simon J. |
| Descriptors: | Hyperactivity; Attention Deficit Disorders; Drug Therapy; Children; Attention Span; Behavior Change; Symptoms (Individual Disorders) |
| Source: | Journal of the American Academy of Child and Adolescent Psychiatry, v44 n6 p530 Jun 2005 |
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| Publisher: | Lippincott Williams & Wilkins, P.O. Box 1620, Hagerstown, MD 21741. Tel: 800-638-3030 (Toll Free); Fax: 301-223-2400. |
| Publication Date: | 2005-06-00 |
| Pages: | 9 |
| Pub Types: | Journal Articles; Reports - Research |
| Abstract: | Objective: To evaluate the long-term tolerability and effectiveness of extended-release mixed amphetamine salts (MAS XR; Adderall XR[R]) in children with attention-deficit/hyperactivity disorder (ADHD). Method: This was a 24-month, multicenter, open-label extension of TWO placebo-controlled studies of MAS XR in children with ADHD aged 6 to 12 years. Subjects (N = 568) began treatment with MAS XR 10 mg once daily, with 10-mg weekly dose increases to optimal effectiveness (maximum dose, 30 mg/d). Effectiveness was assessed with analysis of quarterly Conners Global Index Scale, Parent version (CGIS-P) scores. Tolerability was assessed by monitoring adverse events (AEs), vital signs, physical examinations, and serial laboratory tests. Results: Significant improvements (>30%, p is less than .001) in CGIS-P scores were maintained during long-term treatment. Treatment was well tolerated, and most AEs were mild. The most frequently reported drug-related AEs included anorexia, insomnia, and headache. The incidence of drug-related AEs increased with increasing MAS XR dose, suggesting a dose relationship. Changes in laboratory values and vital signs were modest and not clinically meaningful. Conclusions: In children with ADHD, once-daily 10 mg-30 mg MAS XR was well tolerated and significant behavioral improvements were consistently maintained during 24 months of treatment. |
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| Reference Count: | 0 |
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| Note: | N/A |
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| Record Type: | Journal |
| Level: | N/A |
| Institutions: | N/A |
| Sponsors: | N/A |
| ISBN: | N/A |
| ISSN: | ISSN-0890-8567 |
| Audiences: | N/A |
| Languages: | English |
| Education Level: | N/A |
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