Clinical Effects of Lisdexamfetamine and Mixed Amphetamine Salts Immediate Release in Adult ADHD: Results of a Crossover Design Clinical Trial
Abstract
Objectives To examine the clinical effects of equivalent doses of single-blind (SB; patient-blind) lisdexamfetamine (LDX) and mixed amphetamine salts-immediate release (MAS-IR) on adult attention-deficit/hyperactivity disorder (ADHD) in a placebo (PBO)-controlled, crossover design. Methods Twenty-four subjects were treated sequentially in a fixed order with (1) SB PBO (matching LDX) for 1 week, (2) SB LDX (up to 70 mg/day) for 5 weeks, (3) SB PBO washout for 3 weeks, and (4) open-label treatment MAS-IR (tid up to 45 mg/day) for 5 weeks. Clinical effects on ADHD and executive function were assessed weekly throughout the trial with the ADHD Rating Scale with adult prompts, the Clinical Global Impression Severity Scale (CGI-S), and the Behavior Rating Inventory of Executive Function (BRIEF). Results Lisdexamfetamine and MAS-IR were generally well tolerated. Significant and equal reductions on ADHD clinician ratings were seen. Significantly greater reductions in CGI-S and selected BRIEF subsets were observed in LDX over MAS-IR treatment. However, in general, baseline scores for MAS-IR treatment did not fully return to the LDX baseline. Adherence in this structured and monitored clinical trial was good for once daily LDX and 3 times a day MAS-IR. Conclusions In this crossover study, both LDX and MAS-IR had significant effects on ADHD clinician ratings and measures of executive function (with response rates of about 80%); patients in this monitored clinical trial were adherent with…
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Additional crossover, open-label trial, and placebo-controlled studies comparing LDX with mixed amphetamine salts immediate-release have demonstrated benefits of the stimulant compared with placebo.
“Additional crossover, open-label trial,25 as well as placebo-controlled studies comparing LDX with mixed amphetamine salts immediate-release (MAS-IR) tablets have also demonstrated the benefits of the stimulant compared with placebo”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [26]
CDR-CBT is a set of standardized, validated neuropsychometric tasks for assessing cognitive function in adults with ADHD.
“the Cognitive Drug Research-Computerized Battery of Tests (CDR-CBT), a set of standardized, validated neruopsychometric tasks, for assessing cognitive function in adults with ADHD”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [26]
In the Martin et al pilot study, the primary outcome composite power of attention score improved with both stimulants compared with placebo, and improvements were first noted 2 and 3 hours post dose with MAS-IR and LDX, respectively, and persisted for up to 16 hours post dose, with maximum reductions with both stimulants occurring 5 hours post dose at day 7.
“The primary outcome, the composite power of attention score improved with both stimulants compared with placebo, and improvements were first noted 2 and 3 hours post dose with MAS-IR and LDX, respectively, and persisted for up to 16 hours post dose, with maximum reductions with both stimulants occurring 5 hours post dose at day 7.”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [26]
Cites
Adler, L. A., Goodman, D. W., Kollins, S. H., Weisler, R. H., Krishnan, S., Zhang, Y., & Biederman, J. (2008) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.v69n0903 · Cited by 218 · see citing works
Self-citationWeisler, R., Young, J., Mattingly, G., Gao, J., Squires, L., Adler, L., & 304 Study Group (2009) · CNS Spectrums · doi:10.1017/s1092852900024056 · Cited by 94 · see citing works
Self-citationSpencer, T. J., Adler, L. A., Weisler, R. H., & Youcha, S. H. (2008) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.v69n0911 · Cited by 79 · see citing works
Self-citationDurell, T. M., Adler, L. A., Williams, D. W., Deldar, A., McGough, J. J., Glaser, P. E., Rubin, R. L., Pigott, T. A., Sarkis, E. H., & Fox, B. K. (2013) · Journal of Clinical Psychopharmacology · doi:10.1097/jcp.0b013e31827d8a23 · Cited by 64 · see citing works
Self-citationAdler, L. A., Dirks, B., Deas, P. F., Raychaudhuri, A., Dauphin, M. R., Lasser, R. A., & Weisler, R. H. (2013) · The Journal of Clinical Psychiatry · doi:10.4088/jcp.12m08144 · Cited by 62 · cited 1× · see citing works
“In a study of medication adherence, Adler et al13 found similar efficacy, as assessed by a change in the total ADHD Rating Scale (ADHD-RS) score with adult prompts, of mixed amphetamine salts (MAS) IR and extended release at equivalent doses.”
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Adler, L. A., Alperin, S., Leon, T., & Faraone, S. V. (2017) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2016.0121 · Cited by 28 · see citing works
Self-citationReview of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder
Najib, J., Wimer, D., Zeng, J., Lam, K. W., Romanyak, N., Paige Morgan, E., & Thadavila, A. (2017) · Journal of Central Nervous System Disease · doi:10.1177/1179573517728090 · Cited by 17 · see citing works
- Authors
- Adler, L. A., Alperin, S., Leon, T., & Faraone, S.
- Affiliations
- New York University (US)
- Hofstra University (US)
- SUNY Upstate Medical University (US)
- Venue
- Postgraduate Medicine
- Publisher
- Informa UK Limited
- Published
- 2014-09
- Volume
- 126
- Issue
- 5
- Pages
- 17-24
- ISSN
- 0032-5481 (ISSN-L)
- 1941-9260
- OpenAlex
- W1974974629
- Cited by
- 10
- References
- 5
- Citations by year
- 2021: 1 · 2020: 2 · 2018: 2 · 2017: 2 · 2016: 1 · 2015: 2
- FWCI
- 1.27
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Postgraduate Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- New York City Health and Hospitals Corporation
- Shire
- National Institutes of Health (UL1TR000038)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Keywords
- lisdexamfetamine, mixed amphetamine salts, adult ADHD, stimulant medication, executive function, ADHD symptom severity, medication adherence, drug comparison
- MeSH terms
- Lisdexamfetamine Dimesylate, Adult, Amphetamines, Central Nervous System Stimulants, Attention, Attention Deficit Disorder with Hyperactivity, Delayed-Action Preparations, Dextroamphetamine, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Salts, Single-Blind Method, Cross-Over Studies, Young Adult, Executive Function
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