An interim analysis of the Quality of Life, Effectiveness, Safety, and Tolerability (QU.E.S.T.) evaluation of mixed amphetamine salts extended release in adults with ADHD.
OBJECTIVE
Evaluate safety and efficacy of mixed amphetamine salts extended release (MAS XR) in adults with attention-deficit/hyperactivity disorder (ADHD).


METHODS
10-week interim analysis of the Quality of life, Effectiveness, Safety, and Tolerability (QU.E.S.T.) trial, an ongoing, 30-week, open-label, multicenter investigation of once-daily MAS XR (10-60 mg/day) in adults (>or=18 years of age) with ADHD in community practice settings.


RESULTS
With up to 10 weeks of open-label MAS XR 10 to 60 mg/day (final visit mean dose: 37.2 mg/day), 725 adults exhibited rapid, sustained improvement in ADHD symptoms. At end point, significant decreases from baseline were seen in ADHD Rating Scale IV total scores (-19.8+/-11.6; P<.0001), hyperactivity/impulsivity subscale (-8.1+/-6.1; P<.0001), and inattentive subscale (-11.6+/-6.7; P<.0001). Most subjects (74.4%) were rated as very much/much improved. Based on the 36-item Short Form Health Survey (version 2), significant improvements in quality of life were seen in the domains of general health, physical and mental health, vitality, and social, emotional and physical role functioning (P<.0001). Few subjects (6.9%) withdrew due to adverse events; the most common MAS XR-related adverse events were decreased appetite and dry mouth (19.2% each), insomnia (17.8%), and headache (16.8%).


CONCLUSIONS
In adults with ADHD, MAS XR treatment is generally safe and demonstrates significant improvement in ADHD symptoms and related quality of life.
Goodman
David W
DW
Adult Attention Deficit Disorder Center of Maryland, Johns Hopkins at Green Spring Station, Lutherville, MD 21093, USA. dgoodma4@jhmi.edu
Ginsberg
Lawrence
L
Weisler
Richard H
RH
Cutler
Andrew J
AJ
Hodgkins
Paul
P
D000284:Administration, Oral; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000662:Amphetamines / Q000009:adverse effects / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology*; D016896:Treatment Outcome
D000662:Amphetamines; D000697:Central Nervous System Stimulants; D003692:Delayed-Action Preparations