Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder
Abstract
OBJECTIVE: To evaluate the efficacy and safety of 30, 50, and 70 mg/day lisdexamfetamine dimesylate compared with placebo in adults with attention-deficit/hyperactivity disorder (ADHD). METHOD: Following a 7- to 28-day washout, 420 adults aged 18 to 55 years with moderate to severe ADHD (DSM-IV-TR criteria) were treated with 30, 50, or 70 mg/day lisdexamfetamine or placebo, respectively, for 4 weeks (N = 119, 117, 122, and 62, respectively). The 50- and 70- mg/day groups underwent forced-dose titration. The primary efficacy measure was the clinician-determined ADHD Rating Scale (ADHD-RS) total score. The study was conducted from May 2006 to November 2006. RESULTS: Treatment groups were well matched at baseline, including in ADHD-RS scores. At endpoint, changes in ADHD-RS scores were significantly greater for each lisdexamfetamine dose than for placebo (placebo = -8.2, 30 mg/day lisdexamfetamine = -16.2, 50 mg/day lisdexamfetamine = -17.4, 70 mg/day lisdexamfetamine = -18.6; all p < .0001 vs. placebo), with no differences between doses. Significant differences relative to placebo were observed in each lisdexamfetamine group, beginning at week 1 and for each week throughout. The percentage of subjects who improved (Clinical Global Impressions-Improvement scale rating < or = 2) was significantly greater for each lisdexamfetamine dose than for placebo at each week and at endpoint (placebo = 29%, 30 mg/day lisdexamfetamine = 57%, 50 mg/day lisdexamfetamine = 62%, 70 mg/day lisdexamfetamine = 61%; all p < .01). Adverse events were generally mild and included dry mouth, decreased appetite, and insomnia. CONCLUSION: All 3 lisdexamfetamine doses were significantly more effective than placebo in the treatment of adults with ADHD, with improvements noted within 1 week. Lisdexamfetamine was generally well tolerated by these patients.
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Discontinuations due to TEAEs with LDX in these studies (6.3% and 3.9%) are comparable to a published phase 2 study of LDX in BED, to other clinical studies of LDX for which LDX is indicated, and to other BED pharmacotherapy trials with other agents.
“Discontinuations due to TEAEs with LDX in these studies (6.3% and 3.9%) are comparable to a published phase 2 study of LDX in BED (McElroy et al, 2015), to other clinical studies of LDX for which LDX is indicated (Adler et al, 2008; Wigal et al, 2010), and to other BED pharmacotherapy trials with other agents (Claudino et al, 2007; McElroy et al, 2003, 2007a, b).”
From Lisdexamfetamine Dimesylate for Adults with Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials (2016) · cites this paper as Adler et al, 2008
The safety and tolerability profile of LDX observed regarding overall TEAEs, TEAEs leading to discontinuation, vital signs, and ECGs were consistent with published reports in adults with BED or attention-deficit/hyperactivity disorder.
“The safety and tolerability profile of LDX observed regarding overall TEAEs, TEAEs leading to discontinuation, vital signs, and ECGs were consistent with published reports in adults with BED (McElroy et al, 2015) or attention-deficit/hyperactivity disorder (Adler et al, 2008; Wigal et al, 2010).”
From Lisdexamfetamine Dimesylate for Adults with Moderate to Severe Binge Eating Disorder: Results of Two Pivotal Phase 3 Randomized Controlled Trials (2016) · cites this paper as Adler et al, 2008
LDX is not metabolized by cytochrome P450 enzymes and is unlikely to be involved in drug interactions involving CYP enzymes or P-glycoprotein; however, it is contraindicated during or within 2 weeks following administration of monoamine oxidase inhibitors.
“Lisdexamfetamine dimesylate is not metabolized by cytochrome P450 enzymes and unlikely to be involved in drug interactions involving CYP enzymes or P-glycoprotein; however, it is contraindicated during or within 2 weeks following the administration of monoamine oxidase inhibitors.”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [21]
In placebo-controlled LDX trials in ADHD, participants were considered treatment responders if they had a ≥ 30% reduction in ADHD symptoms using a standardized scale.
“in placebo-controlled LDX trials in ADHD, participants were considered treatment “responders” if they had a ≥ 30% reduction in ADHD symptoms using a standardized scale [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 [27]
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 [27]
Previously reported abuse liability studies support reduced abuse potential of LDX administered orally at doses ≤150 mg or intravenously at doses ≤50 mg, compared with d-amphetamine immediate-release 40 mg oral or 20 mg intravenous doses.
“Previously reported abuse liability studies support the reduced abuse potential of LDX administered orally at doses ≤150 mg or intravenously at doses ≤50 mg, compared with d-amphetamine immediate-release 40 mg oral or 20 mg intravenous doses, respectively.21”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [21]
An intention-to-treat analysis was applied in two studies.
“An intention-to-treat analysis was applied in two studies.16,18”
From Exploratory meta-analysis on lisdexamfetamine versus placebo in adult ADHD (2014) · cites this paper as [16]
Only one study reported remission rates, so pooled remission rate could not be calculated.
“Unfortunately, only one study reported remission rates,16 and its pooled remission rate could not be calculated.”
From Exploratory meta-analysis on lisdexamfetamine versus placebo in adult ADHD (2014) · cites this paper as [16]
Some randomized controlled trials of lisdexamfetamine demonstrated efficacy and tolerability compared with placebo in adult ADHD but had limited sample size.
“Although some randomized controlled trials (RCTs) of LDX demonstrated its efficacy and tolerability, compared with placebo, in the treatment of adult ADHD,16,18–21 they had a limited sample size.”
From Exploratory meta-analysis on lisdexamfetamine versus placebo in adult ADHD (2014) · cites this paper as [16]
Lisdexamfetamine is an effective, safe, well-tolerated medication for children aged 6 to 12 years through to adulthood with ADHD.
“The evidence suggests that LDX is an effective, safe, well-tolerated medication for children aged 6 to 12 years through to adulthood, with ADHD.16,17”
From Exploratory meta-analysis on lisdexamfetamine versus placebo in adult ADHD (2014) · cites this paper as [16]
Blinding of outcome assessment was reported in three trials.
“Additionally, allocation concealment was reported in two trials18,21 and blinding of outcome assessment was reported in three trials.16,20,21”
From Exploratory meta-analysis on lisdexamfetamine versus placebo in adult ADHD (2014) · cites this paper as [16]
In that trial, 6% of subjects in the lisdexamfetamine group discontinued the drug owing to side effects, the most common being insomnia; palpitations, hypertension, and dyspnea were also more common in the treatment group than in the placebo group.
“Six percent of subjects in the lisdexamfetamine group discontinued the drug owing to side effects, the most common being insomnia. Palpitations, hypertension, and dyspnea were also more common in the treatment group than in the placebo group.”
From Update on optimal use of lisdexamfetamine in the treatment of ADHD (2013) · cites this paper as [27]
In a randomized placebo-controlled trial of 420 adults with ADHD, Adler et al found statistically significant improvements in ADHD-RS-IV and CGI scores for all doses of lisdexamfetamine (30-50 mg) compared with placebo, evident from the first week.
“In a randomized, placebo-controlled trial of 420 adult subjects with ADHD, Adler et al27 found statistically significant improvements in ADHD-RS-IV and CGI scores for all doses of lisdexamfetamine (30–50 mg) compared with placebo. These improvements were evident from the first week.”
From Update on optimal use of lisdexamfetamine in the treatment of ADHD (2013) · cites this paper as [27]
These common AEs are consistently seen in studies of long-acting stimulant medications administered to adults.
“The common AEs in the current study, including decreased appetite, dry mouth, headache, and insomnia, are consistently seen in studies of long-acting stimulant medications administered to adults [12,18,35,36].”
LDX has demonstrated efficacy in reducing core ADHD symptoms in a randomized, controlled trial in adults.
“LDX has demonstrated efficacy in reducing core ADHD symptoms in a randomized, controlled trial in adults [26], using the ADHD Rating Scale IV (ADHD-RS-IV) [27,28]”
The overall safety and tolerability findings observed in these studies are consistent with previously published studies of LDX augmentation for MDD and with other clinical studies of LDX for which LDX is approved for use.
“The overall safety and tolerability findings observed in these studies are consistent with previously published studies of LDX augmentation for MDD with other clinical studies of LDX for which LDX is approved for use (Adler et al., 2008;Madhoo et al., 2014;McElroy et al., 2016;Trivedi et al., 2013Wigal et al., 2010).”
Multiple randomized, double-blind, placebo-controlled trials have shown LDX to be an effective treatment for children, adolescents and adults with ADHD, with a tolerability and safety profile consistent with the known effects of psychostimulant therapy.
“Multiple randomized, double-blind, placebo-controlled trials have shown LDX to be an effective treatment for children, adolescents and adults with ADHD, with a tolerability and safety profile consistent with the known effects of psychostimulant therapy [9–15].”
These results support previous placebo-controlled trials of LDX, which have demonstrated a robust treatment response in a range of patient groups.
“These results support previous placebo-controlled trials of LDX, which have demonstrated a robust treatment response in a range of patient groups [9, 11–13].”
Both therapies displayed safety profiles consistent with findings from previous studies.
“Both therapies displayed safety profiles consistent with findings from previous studies [9, 11–13, 28–30].”
The most frequently reported TEAEs in the LDX treatment group (decreased appetite, decreased weight, headache, nausea and insomnia) and in patients receiving ATX (headache, nausea, somnolence, decreased appetite and fatigue) are consistent with findings from previous studies.
“The most frequently reported TEAEs in the LDX treatment group (decreased appetite, decreased weight, headache, nausea and insomnia) and in patients receiving ATX (headache, nausea, somnolence, decreased appetite and fatigue) are consistent with findings from previous studies [9, 11–13, 28–30].”
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- Authors
- Adler, L. A., Goodman, D. W., Kollins, S. H., Weisler, R. H., Krishnan, S., Zhang, Y., & Biederman, J.
- Affiliations
- NYU Langone Health (US)
- Duke University (US)
- University of North Carolina at Chapel Hill (US)
- Harvard University (US)
- Venue
- The Journal of Clinical Psychiatry
- Publisher
- Physicians Postgraduate Press, Inc
- Published
- 2008-09-30
- Volume
- 69
- Issue
- 9
- Pages
- 1364-1373
- ISSN
- 0160-6689 (ISSN-L)
- OpenAlex
- W1979206088
- Cited by
- 218
- References
- 28
- Citations by year
- 2026: 3 · 2025: 3 · 2024: 14 · 2023: 5 · 2022: 12 · 2021: 5 · 2020: 5 · 2019: 6 · 2018: 10 · 2017: 16 · 2016: 9 · 2015: 9 · 2014: 19 · 2013: 22 · 2012: 14
- FWCI
- 15.42
- 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
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Keywords
- lisdexamfetamine dimesylate, adult ADHD, ADHD medication, dose comparison, ADHD Rating Scale, adverse events, stimulant efficacy, xerostomia, appetite loss, insomnia, placebo response, washout period
- MeSH terms
- Lisdexamfetamine Dimesylate, Adolescent, Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Dextroamphetamine, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Personality Assessment, Young Adult
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