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
Abstract
OBJECTIVE: To assess the quality of life (QOL) in adults with attention-deficit/hyperactivity disorder (ADHD) given triple-bead mixed amphetamine salts (MAS), a long-acting amphetamine formulation designed for a duration of action of up to 16 hours. METHOD: 274 adults with ADHD (DSM-IV-TR criteria) were randomly assigned to 7 weeks of double-blind treatment with an optimal dose of triple-bead MAS (12.5 mg to 75 mg) (N = 137) or placebo (N = 137). As a secondary objective of this study, QOL was assessed on the basis of self-reported Adult ADHD Impact Module (AIM-A) scores, describing ADHD-specific QOL in 6 domains and global QOL (questions 1-4). To assess safety, data were collected on adverse events, vital signs, electrocardiograms, laboratory tests, and sleep quality. The trial was conducted from January 2005 to June 2005. RESULTS: Statistically significant improvement between triple-bead MAS and placebo was observed in all 6 ADHD-specific AIM-A subscales. In addition, statistically significant improvement in global QOL between triple-bead MAS and placebo was seen, based on AIM-A question 1 (p = .0006) and question 4 (p = .0001). Patients' age, gender, race, and prior use of stimulant medication were not found to significantly affect AIM-A subscale scores. The most common treatment-emergent adverse events with triple-bead MAS (insomnia, dry mouth, decreased appetite, headache, and weight decreased) were consistent with amphetamine treatment, and their incidence generally decreased with time. CONCLUSIONS: Adults with ADHD showed significantly improved QOL for both ADHD-specific and global measures with triple-bead MAS in comparison to placebo, based on AIM-A scores. Treatment-emergent adverse events were mostly mild to moderate in intensity and were consistent with amphetamine treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00150579.
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The AIM-A multi-item scale is a validated QOL measure that has demonstrated treatment sensitivity in a double-blind, placebo-controlled study of a long-acting psychostimulant.
“The self-reported Adult ADHD Impact Module (AIM-A) [22] multi-item scale is a validated QOL measure that has demonstrated treatment sensitivity in a double-blind, placebo-controlled study of a long-acting psychostimulant [23].”
The broad improvements in participant-perceived QOL observed in this trial are in line with those previously described with psychostimulant and nonstimulant treatment in children, adolescents, and adults with ADHD.
“The broad improvements in participant-perceived QOL observed currently are in line with those described previously with psychostimulant and nonstimulant treatment in children, adolescents, and adults with ADHD (Spencer et al. 2008; Cannon et al. 2009; Gerwe et al. 2009; Brown and Landgraf 2010; Wehmeier et al. 2010; Berek et al. 2011; Brams et al. 2011).”
From Participant-Perceived Quality of Life in a Long-Term, Open-Label Trial of Lisdexamfetamine Dimesylate in Adolescents with Attention-Deficit/Hyperactivity Disorder (2014) · cites this paper as Spencer et al. 2008
Adolescent/young adult perspectives on QOL and the impact of treatment may play a role in decisions to continue treatment as well as the perceived value of such treatment.
“Moreover, adolescent/young adult perspectives on QOL and the impact of treatment may play a role in decisions to continue treatment as well as the perceived value of such treatment (Spencer et al. 2008).”
From Participant-Perceived Quality of Life in a Long-Term, Open-Label Trial of Lisdexamfetamine Dimesylate in Adolescents with Attention-Deficit/Hyperactivity Disorder (2014) · cites this paper as Spencer et al. 2008
There is increasing recognition of the importance of evaluating the impact of therapy on QOL.
“There is increasing recognition of the importance of evaluating the impact of therapy on QOL (Spencer et al. 2008; Wehmeier et al. 2010)”
From Participant-Perceived Quality of Life in a Long-Term, Open-Label Trial of Lisdexamfetamine Dimesylate in Adolescents with Attention-Deficit/Hyperactivity Disorder (2014) · cites this paper as Spencer et al. 2008
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“Recent studies suggest that central stimulant treatment is beneficial for adult function in general (Spencer et al., 2008), thus possibly a predictor of occupational function.”
BackgroundCoghill, D., Banaschewski, T., Soutullo, C. A., Cottingham, M. G., & Zuddas, A. (2017) · European Child & Adolescent Psychiatry · doi:10.1007/s00787-017-0986-y · Cited by 130 · see citing works
“Effect sizes were not calculable for the other two studies that used the AIM-A, but significant placebo-adjusted effects of MAS-XR3 (triple-bead mixed amphetamine salts extended release) were reported in all domains in one study [85] and of OROS-MPH in three to four domains, depending on dose, in the other [25].”
BackgroundResultInfluentialCoghill, D. (2010) · CNS Drugs · doi:10.2165/11537450-000000000-00000 · Cited by 103 · see citing works
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“Studies on HRQoL in adults with ADHD have mostly been related to pharmacological trials in younger age groups of adults (Adler et al., 2006; Brod, Perwien, Adler, Spencer, & Johnston, 2005; Mattos, Louza, Palmini, Oliveira, & Rocha, 2012; Spencer et al., 2008; Weiss et al., 2010).”
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Do stimulants improve functioning in adults with ADHD?
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“This instrument was administered in two studies of long acting amphetamines; one placebo-controlled (Spencer et al., 2008) and one open label (Weiss et al.”
BackgroundMethodAdler, L. A., Dirks, B., Deas, P., Raychaudhuri, A., Dauphin, M., Saylor, K., & Weisler, R. (2013) · BMC Psychiatry · doi:10.1186/1471-244x-13-253 · Cited by 45 · see citing works
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“Illustration Brian noted that he was easily frustrated with child care duties and did not like to be interrupted when working at home because he had difficulties refocusing on what he was doing, which was a central source of conflict with his wife (53)”
BackgroundInfluentialToward Quality Care in ADHD: Defining the Goals of Treatment
Rostain, A., Jensen, P. S., Connor, D. F., Miesle, L. M., & Faraone, S. V. (2015) · Journal of Attention Disorders · doi:10.1177/1087054712473835 · Cited by 33 · see citing works
“Articles Containing Predefined Criteria for “Treatment Response” Abikoff et al., 2005; Adler, Goodman et al., 2008; Adler, Liebowitz et al., 2009; Ahmann et al., 2001; Armenteros, Lewis, & Davalos, 2007; Arnold et al., 2004; Bangs et al., 2007; Barkley, Guevremont, Anastopoulos, DuPaul, & Shelton, 1993; Biederman et a…”
BackgroundBuitelaar, J. K., Casas, M., Philipsen, A., Kooij, J. J. S., Ramos‐Quiroga, J. A., Dejonckheere, J., van Oene, J. C., & Schäuble, B. (2011) · Psychological Medicine · doi:10.1017/s0033291711000845 · Cited by 28 · see citing works
“In two 7-week studies in adults with ADHD treated with mixed amphetamine salts, improvements in health-related quality of life assessed using the disease-specific ADHD Impact Module (AIM-A) were significantly greater than those in subjects receiving placebo (Spencer et al. 2008a,b).”
MethodLong-Term Effects of Stimulant Treatment for ADHD: What Can We Tell Our Patients?
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“In two 7-week studies in adults with ADHD treated with mixed amphetamine salts, improvements in health-related quality of life assessed using the disease-specifi c ADHD Impact Module were signifi cantly greater than those in subjects receiving placebo (Spencer et al. 2008a,b).”
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“The fact that both HRQoL and symptoms are found to improve simultaneously after central stimulant treatment (Adler et al., 2006; Matza et al., 2006; Spencer et al., 2008; M. D. Weiss et al., 2010) indicates that HRQoL is affected by symptom severity.”
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“Pharmacological treatment is known to improve quality of life (Adler et al., 2008; Spencer et al., 2008) and increase social and psychological functioning (Gørksoyr and Nøttestad, 2008).”
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“A growing research issue is also the quality of life under stimulant medication (Spencer et al. 2008).”
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“9% for a 12-h mixed amphetamine salt product [26], and 19 versus 5% for lisdexamfetamine [23].”
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“There is increasing recognition of the importance of evaluating the impact of therapy on QOL (Spencer et al. 2008; Wehmeier et al. 2010); relief of core clinical symptoms may not necessarily lead to ‘‘normalized’’ functioning.”
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- Authors
- Spencer, T. J., Landgraf, J. M., Adler, L. A., Weisler, R. H., Anderson, C. S., & Youcha, S. H.
- Affiliations
- Massachusetts General Hospital (US)
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2008-11-30
- Volume
- 69
- Issue
- 11
- Pages
- 1766-1775
- ISSN
- 0160-6689 (ISSN-L)
- OpenAlex
- W2000421003
- Cited by
- 39
- References
- 0
- Citations by year
- 2024: 2 · 2022: 4 · 2021: 1 · 2018: 1 · 2017: 3 · 2015: 4 · 2014: 2 · 2013: 5 · 2012: 2
- FWCI
- 3.51
- 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
- Life Sciences › Neuroscience › Cognitive Neuroscience › Neuroethics, Human Enhancement, Biomedical Innovations
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Keywords
- attention deficit hyperactivity disorder, adults, quality of life, treatment-emergent adverse events, stimulant medication, insomnia
- MeSH terms
- Adult, Amphetamine, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Delayed-Action Preparations, Double-Blind Method, Female, Humans, Male, Middle Aged, Quality of Life, Least-Squares Analysis
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