Maintenance of Efficacy of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder: Randomized Withdrawal Design
Abstract
Objective To evaluate lisdexamfetamine dimesylate maintenance of efficacy in adults with attention-deficit/hyperactivity disorder (ADHD). Method Adults (aged 18-55 years) who had ADHD meeting DSM-IV-TR criteria, baseline ADHD Rating Scale-IV (ADHD-RS-IV) with adult prompts total scores of Results A total of 116 participants were randomized (lisdexamfetamine dimesylate n = 56; placebo n = 60). At the randomized withdrawal phase baseline, mean (SD) ADHD-RS-IV scores for lisdexamfetamine dimesylate and placebo were 10.6 (4.96) and 10.6 (4.82), respectively. At endpoint, 8.9% (5/56) of adults taking lisdexamfetamine dimesylate and 75.0% (45/60) taking placebo (P Conclusions In adults with ADHD on medium- to long-term treatment, lisdexamfetamine dimesylate demonstrated maintenance of efficacy vs placebo upon randomized withdrawal. A majority of patients given placebo showed symptom relapse by 2 weeks. The safety profile of lisdexamfetamine dimesylate was generally consistent with previous lisdexamfetamine dimesylate studies. Trial registration ClinicalTrials.gov identifier: NCT00877487.
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In the Weisler et al extension study, participants who received LDX previously compared with those who were LDX naïve had mean improvements in ADHD-RS-IV total scores of 61.6% and 55.1%, respectively.
“Participants, who received LDX previously compared with those who were LDX naïve, had mean improvements in ADHD-RS-IV total scores of 61.6% and 55.1%, respectively.”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [28]
In the Weisler et al extension study, at end point, 84.1% of patients noted an improvement in overall functioning as measured by CGI-I, with similar responses in prior LDX-treated and LDX-naïve patients (84.8% and 79.6%, respectively).
“at end point, 84.1% of patients noted an improvement in overall functioning as measured by the CGI-I, with similar responses noted in both the prior LDX-treated patients and LDX-naïve patients (84.8% and 79.6%, respectively).”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [28]
In the Weisler et al open-label extension study, mean change in ADHD-RS-IV total score from baseline to end of study period was −24.8, corresponding to a 60.7% mean relative improvement from baseline.
“The mean change in ADHD-RS-IV total score from baseline to end of study period was −24.8 (P < .0001), which corresponded to a 60.7% mean relative improvement from baseline (P < .0001).”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [28]
During the open-label extension study, 87.7% of patients experienced adverse events, and similar percentages were noted between LDX-naïve patients and those who had received LDX previously.
“During the open-label extension study,28 87.7% of patients experienced adverse events, and similar percentages were noted between LDX-naïve patients and those who had received LDX previously.”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [28]
Upper respiratory tract infection, insomnia, headache, dry mouth, decreased appetite, and irritability were the most commonly reported adverse events.
“Upper respiratory tract infection, insomnia, headache, dry mouth, decreased appetite, and irritability were the most commonly reported adverse events reported.”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [28]
In Brams et al randomized withdrawal study of 116 adults with ADHD stable on lisdexamfetamine, most patients switched to the placebo group relapsed within 2 weeks.
“Brams et al30 used a novel design of randomized withdrawal, in which 116 adult patients with ADHD and stable on lisdexamfetamine were randomized to placebo or lisdexamfetamine. Their results showed that most of the patients switched to the placebo group relapsed within 2 weeks.”
From Update on optimal use of lisdexamfetamine in the treatment of ADHD (2013) · cites this paper as [30]
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- Authors
- Brams, M., Weisler, R., Findling, R. L., Gasior, M., Hamdani, M., Ferreira-Cornwell, M. C., & Squires, L.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- Case Western Reserve University (US)
- Corresponding author
- Brams, Matthew
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2012-06-12
- Volume
- 73
- Issue
- 07
- Pages
- 977-983
- ISSN
- 0160-6689 (ISSN-L)
- OpenAlex
- W1999725272
- Cited by
- 41
- References
- 0
- Citations by year
- 2026: 1 · 2025: 2 · 2024: 1 · 2023: 2 · 2022: 4 · 2019: 2 · 2018: 1 · 2017: 1 · 2016: 3 · 2015: 8 · 2014: 11 · 2013: 5
- FWCI
- 5.46
- 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 › Psychiatry and Mental health › Schizophrenia research and treatment
- Keywords
- lisdexamfetamine dimesylate, adult ADHD, treatment withdrawal, symptom recurrence, stimulant medication, ADHD medication, treatment-emergent adverse events, ADHD Rating Scale-IV, open-label extension, dose titration
- MeSH terms
- Lisdexamfetamine Dimesylate, Adolescent, Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Dextroamphetamine, Dose-Response Relationship, Drug, Double-Blind Method, Female, Follow-Up Studies, Humans, Long-Term Care, Male, Substance Withdrawal Syndrome, Treatment Outcome, Secondary Prevention, Young Adult
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