Triple-Bead Mixed Amphetamine Salts (SPD465), a Novel, Enhanced Extended-Release Amphetamine Formulation for the Treatment of Adults With ADHD: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study
J Clin Psychiatry 2008;69(9):1437-1448
© Copyright 2015 Physicians Postgraduate Press, Inc.
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The efficacy and safety of triple-bead mixed
amphetamine salts (MAS), an oral, once-daily, enhanced extended-release
amphetamine formulation designed for a duration of action up to 16 hours, were
evaluated in adults with attention-deficit/hyperactivity disorder (ADHD).
Method: In this phase 3, 7-week, randomized, double-blind,
multicenter, placebo-controlled, parallel-group, dose-optimization study of 272
adults with ADHD (DSM-IV-TR criteria), subjects (aged 18 to 55 years) were
randomly assigned to triple-bead MAS (starting dose 12.5 mg) or placebo. The
primary outcome measure was change in ADHD Rating Scale-IV (ADHD-RS-IV).
Secondary outcome measures included Clinical Global Impressions (CGI) scale,
Time-Sensitive ADHD Symptom Scale (TASS) (measuring extended duration), Brown
Attention-Deficit Disorder Scale (BADDS) (measuring executive function), Adult
ADHD Impact Module (AIM-A) (measuring quality of life [QOL]), and ADHD-RS-IV
hyperactivity-impulsivity and inattentiveness subscales. Adverse events (AEs),
vital signs, electrocardiograms (ECGs), and laboratory data were collected. The
trial was conducted from January 2005 to June 2005.
Results: Triple-bead MAS resulted in significantly greater
improvement versus placebo in mean ADHD-RS-IV total score change (p < .0001),
CGI-Improvement (p < .0001), TASS total score at 13-16 hours postdose (p =
.002), BADDS total score (p < .0001), all AIM-A domains (p <= .01), and
ADHD-RS-IV subscales (p < .01), demonstrating extended duration of efficacy and
improvements in executive function and QOL. The most common treatment-emergent
AEs included insomnia, dry mouth, decreased appetite and weight, and headache.
Most treatment-emergent AEs were mild or moderate in severity.
Conclusions: Triple-bead MAS was significantly more effective
than placebo in treating adult ADHD. The extended duration of action up to 16
hours and significant improvements in executive function and QOL address unique
treatment needs of adults with ADHD. Treatment-emergent AEs with triple-bead
MAS were consistent with amphetamine treatment.
Trial Registration: clinicaltrials.gov Identifier: NCT00150579