Open-Label Administration of Lisdexamfetamine Dimesylate Improves Executive Function Impairments and Symptoms of Attention-Deficit/Hyperactivity Disorder in Adults
Abstract
Introduction/objective Executive function (EF) impairment in attention-deficit/hyperactivity disorder (ADHD) may account for behavioral symptoms such as poor concentration, impaired working memory, problems in shifting among tasks, and prioritizing and planning complex sets of tasks or completing long-term projects at work or school. Poor self-regulation and control of emotional behaviors frequently are seen in patients with ADHD. This study assessed EF behaviors in adults with ADHD at baseline and after 4 weeks of treatment with lisdexamfetamine dimesylate (LDX). Methods Executive function behavior was assessed using the Brown Attention-Deficit Disorder Scale (BADDS) during the 4-week open-label dose-optimization phase prior to a 2-period, randomized, double-blind, placebo-controlled crossover study of LDX (30-70 mg/day). The ADHD Rating Scale IV (ADHD-RS-IV) with adult prompts assessed ADHD symptoms. Change in EF behavioral symptoms was evaluated based on week 4 BADDS total and cluster scores; analyses of shifts from baseline among subjects with BADDS scores Results At week 4, BADDS total and cluster scores were reduced (ie, improved; all P Conclusion Clinically optimized doses of LDX (30-70 mg/day) significantly improved EF behaviors in adults with ADHD. Treatment-emergent adverse events with LDX were consistent with those observed with long-term stimulant use.
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LS mean treatment differences for BRIEF-A GEC, BRI, and MCI showed significant improvement with LDX over placebo: −11.2, −8.4, and −11.6, respectively, all P ≤ .0002.
“The LS mean treatment difference for GEC, BRI, and MCI noted significant improvement with LDX over placebo at −11.2, −8.4, and −11.6, respectively, all P’s ≤ .0002).”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [40]
In a 10-week study, participant ratings of improvement in executive functioning deficits were 2-fold greater than informant ratings at week 10/early termination.
“Participant ratings of improvement in executive functioning deficits were 2-fold greater than those of informant ratings at study week 10/early termination.”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [40]
Informant-rated EF deficits, using BRIEF-A GEC and Index T scores, improved significantly more with LDX compared with placebo and in a similar manner to self-reported EF deficits.
“Informant-rated EF deficits, using BRIEF-A GEC and Index T scores, improved significantly more with LDX compared with placebo treatment and in a similar manner to self-reported EF deficits.”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [40]
Treatment response to LDX in this trial (81.7%) was similar to that observed in a 4-week open-label placebo-controlled trial of LDX for adult ADHD (78.9%) using the same metric.
“was similar to that observed in a 4-week open-label placebo-controlled trial of LDX for adult ADHD (78.9%) using the same metric [16].”
From Treating new-onset cognitive complaints after risk-reducing salpingo-oophorectomy: A randomized controlled crossover trial of lisdexamfetamine (2024) · cites this paper as [16]
BADDS scores predict clinical diagnosis of ADHD and multiple ADHD medication trials use the BADDS to assess symptom severity and improvement.
“BADDS scores predict clinical diagnosis of ADHD [36] and multiple ADHD medication trials use the BADDS to assess symptom severity and improvement [16,37–39].”
From Treating new-onset cognitive complaints after risk-reducing salpingo-oophorectomy: A randomized controlled crossover trial of lisdexamfetamine (2024) · cites this paper as [16]
Improvements observed from LDX versus placebo in this trial were comparable to those observed in LDX interventions for adults with ADHD.
“Improvements observed from LDX versus placebo in this trial were comparable to those observed in LDX interventions for adults with ADHD [16,27–29].”
From Treating new-onset cognitive complaints after risk-reducing salpingo-oophorectomy: A randomized controlled crossover trial of lisdexamfetamine (2024) · cites this paper as [16]
Brown et al small open-label study showed a statistically significant improvement in executive functioning in ADHD subjects treated with lisdexamfetamine using the Brown Attention-Deficit Disorder Scale.
“Other research that examined the efficacy of lisdexamfetamine in an academic or work environment includes a small open-label study Brown et al37 that showed a statistically significant improvement in executive functioning in ADHD subjects treated with lisdexamfetamine using the Brown Attention-Deficit Disorder Scale.”
From Update on optimal use of lisdexamfetamine in the treatment of ADHD (2013) · cites this paper as [37]
LDX was associated with improvements from baseline in EF, using the validated, self-reported BADDS, during the open-label phase of a modified analog classroom study (4-week) of adults with ADHD.
“and was associated with improvements from baseline in EF, using the validated, self-reported BADDS [13,29], during the open-label phase of a modified analog classroom study (4-week) of adults with ADHD [30].”
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Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder
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- Authors
- Brown, T. E., Brams, M., Gao, J., Gasior, M., & Childress, A.
- Affiliations
- Yale University (US)
- Principal Investigator, Bayou City Research, Houston, TX
- Takeda (United States) (US)
- Center for Psychiatry and Behavioral Medicine (US)
- Corresponding author
- Brown, Thomas E.
- Venue
- Postgraduate Medicine
- Publisher
- Informa UK Limited
- Published
- 2010-09-01
- Volume
- 122
- Issue
- 5
- Pages
- 7-17
- ISSN
- 0032-5481 (ISSN-L)
- 1941-9260
- OpenAlex
- W2047273149
- Cited by
- 29
- References
- 17
- Citations by year
- 2025: 1 · 2024: 1 · 2022: 1 · 2020: 3 · 2019: 2 · 2017: 2 · 2016: 2 · 2015: 2 · 2014: 1 · 2013: 5 · 2012: 5
- FWCI
- 3.05
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Postgraduate Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- lisdexamfetamine dimesylate, adult ADHD, executive function, stimulant medication, ADHD Rating Scale-IV, dose optimization, treatment-emergent adverse events, working memory, self-regulation, ADHD symptoms, open-label extension, stimulant side effects, task shifting, irritability
- MeSH terms
- Lisdexamfetamine Dimesylate, Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Dextroamphetamine, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Cross-Over Studies, Executive Function
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