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

Spencer, Thomas J.; Adler, Lenard A.; Weisler, Richard H.; Youcha, Sharon H.

doi:10.4088/jcp.v69n0911

Cited by 79Attention Deficit Hyperactivity DisorderPharmacology and Obesity TreatmentPharmaceutical studies and practices

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

Spencer, Thomas J., Adler, Lenard A., Weisler, Richard H., Youcha, Sharon H.·2008·The Journal of Clinical Psychiatry

DOI 10.4088/jcp.v69n0911

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Abstract

Introduction 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 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 ad…

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Efficacy of long-acting stimulants in the laboratory school setting has been demonstrated for children with ADHD across the day and at 12 and 13 hours postdose.
“While similar studies in adults are limited, efficacy of long-acting stimulants in the laboratory school setting has been demonstrated for children with ADHD across the day and at 12 [15,22,25,33,34] and 13 hours postdose [16].”
From Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design (2010) · cites this paper as [25]
The AIM-A QOL data from this study are consistent with a 7-week RCT of extended-release mixed amphetamine salts that demonstrated significantly improved QOL at study endpoint relative to placebo.
“The AIM-A QOL data from the present study were consistent with a 7-week, randomized controlled ADHD study of an extended-release mixed amphetamine salts formulation that also demonstrated significantly improved QOL at study endpoint relative to placebo [39].”
From Self-Reported quality of life in adults with attention-deficit/hyperactivity disorder and executive function impairment treated with lisdexamfetamine dimesylate: a randomized, double-blind, multicenter, placebo-controlled, parallel-group study (2013) · cites this paper as [39]
Individuals with ADHD experience neuropsychological difficulties associated with deficient inhibition, memory, executive functioning, decision making, and emotional dysregulation.
“Individuals with ADHD also experience neuropsychological difficulties associated with deficient inhibition [22], memory [22], executive functioning [23,24], decision making [25], and emotional dysregulation [26].”
From Adult ADHD and comorbid disorders: clinical implications of a dimensional approach (2017) · cites this paper as [24]

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Triple-Bead Mixed Amphetamine Salts (SHP465) in Adults With ADHD: Results of a Phase 3, Double-Blind, Randomized, Forced-Dose Trial
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A Long-Term, Open-Label, Safety Study of Triple-Bead Mixed Amphetamine Salts (SHP465) in Adults With ADHD
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Self-citation
Attention-Deficit/Hyperactivity Disorder-Specific Quality of Life With Triple-Bead Mixed Amphetamine Salts (SPD465) in Adults: Results of a Randomized, Double-Blind, Placebo-Controlled Study
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A Single-Blind, Placebo Controlled Trial of Triple Beaded Mixed Amphetamine Salts in DSM-5 Adults With ADHD Assessing Effects Throughout the Day
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Self-citation
Triple-Bead Mixed Amphetamine Salt for ADHD
Strawn, J. R., & Picard, L. S. (2017) · Current psychiatry

Authors: Spencer, T. J., Adler, L. A., Weisler, R. H., & Youcha, S. H.
Affiliations: Harvard University (US)
ORCID: Spencer, Thomas J.
Adler, Lenard A.
Venue: The Journal of Clinical Psychiatry
Publisher: Physicians Postgraduate Press, Inc
Published: 2008-09-30
Volume: 69
Issue: 9
Pages: 1437-1448
ISSN: 0160-6689 (ISSN-L)
DOI: 10.4088/jcp.v69n0911
OpenAlex: W2076504554
Cited by: 79
References: 0
Citations by year: 2026: 1 · 2025: 6 · 2024: 3 · 2023: 1 · 2022: 3 · 2021: 2 · 2020: 6 · 2019: 3 · 2018: 3 · 2017: 9 · 2016: 3 · 2015: 2 · 2014: 8 · 2013: 7 · 2012: 2
FWCI: 4.68
Type: journal article
Language: en
Open access: closed
Locations: The Journal of Clinical Psychiatry (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
Keywords: adult ADHD, ADHD medication, executive function, quality of life, hyperactivity/impulsivity, inattention, adverse events, ADHD Rating Scale-IV, dose optimization, once-daily dosing, duration of action, insomnia, weight loss
MeSH terms: Adolescent, Adult, Amphetamines, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Delayed-Action Preparations, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Neuropsychological Tests, Quality of Life

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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

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