Document Detail


Long-term safety and effectiveness of mixed amphetamine salts extended release in adults with ADHD.
MedLine Citation:
PMID:  16344837     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: Assess the long-term safety and effectiveness of mixed amphetamine salts extended release (MAS XR) in adults with attention-deficit/hyperactivity disorder (ADHD) combined subtype. METHODS: A 24-month, open-label extension of a 4-week, multicenter, double-blind, placebo-controlled, parallel-group, forced-dose-escalation study of MAS XR in adults (>or=18 years of age) with ADHD. The 223 enrolled subjects started treatment at 20 mg/day for 1 week, with subsequent titration up to 60 mg/day for optimal therapeutic effects. At monthly visits, efficacy was assessed based on the ADHD Rating Scale IV (ADHD-RS-IV). Safety assessments included spontaneously reported adverse events, laboratory assessments, and monitoring of vital signs. FINDINGS: ADHD symptoms significantly improved for all subjects as measured by change from baseline in mean ADHD-RS-IV total scores (-7.2+/-13.04 unit points; P<.001); this was sustained for up to 24 months. The most common treatment-related adverse events were dry mouth (43% of subjects reporting at least one occurrence), infection (33%), insomnia (32%), anorexia/decreased appetite (32%), headache (30%), and nervousness (26%). Most adverse events were mild to moderate in intensity. CONCLUSION: Treatment with MAS XR 20-60 mg/day for adult ADHD was generally well tolerated and was associated with sustained symptomatic improvement for up to 24 months.
Authors:
Joseph Biederman; Thomas J Spencer; Timothy E Wilens; Richard H Weisler; Stephanie C Read; Simon J Tulloch;
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  CNS spectrums     Volume:  10     ISSN:  1092-8529     ISO Abbreviation:  CNS Spectr     Publication Date:  2005 Dec 
Date Detail:
Created Date:  2005-12-13     Completed Date:  2006-03-08     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9702877     Medline TA:  CNS Spectr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  16-25     Citation Subset:  IM    
Affiliation:
Massachusetts General Hospital, Harvard Medical School, Boston 02114, USA. jbiederman@partners.org
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Adult
Adverse Drug Reaction Reporting Systems
Amphetamines / adverse effects,  therapeutic use*
Attention Deficit Disorder with Hyperactivity / drug therapy*,  psychology
Delayed-Action Preparations
Dose-Response Relationship, Drug
Double-Blind Method
Female
Humans
Long-Term Care
Male
Quality of Life / psychology
Treatment Outcome
Chemical
Reg. No./Substance:
0/Amphetamines; 0/Delayed-Action Preparations

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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