Efficacy and Safety of Lisdexamfetamine Dimesylate in Adolescents With Attention-Deficit/Hyperactivity Disorder
Abstract
Objective To examine lisdexamfetamine dimesylate (LDX) efficacy and safety versus placebo in adolescents with attention-deficit/hyperactivity disorder (ADHD).Method Adolescents (13 through 17) with at least moderately symptomatic ADHD (ADHD Rating Scale IV: Clinician Version [ADHD-RS-IV] score ≥28) were randomized to placebo or LDX (30, 50, or 70 mg/d) in a 4-week, forced-dose titration, double-blind study. Primary and secondary efficacy measures were the ADHD-RS-IV, Clinical Global Impressions-Improvement (CGI-I), and Youth QOL-Research Version (YQOL-R). Safety assessments included treatment-emergent adverse events (TEAEs), vital signs, laboratory findings, physical examinations, and ECG.Results Overall, 314 participants were randomized; 309 were in efficacy analyses and 49 withdrew (11 due to TEAEs). Least squares mean (SE) change from baseline at endpoint in ADHD-RS-IV total scores were -18.3 (1.25), -21.1 (1.28), -20.7 (1.25) for 30, 50, and 70 mg/d LDX, respectively; -12.8 (1.25) for placebo (p ≤ .0056 versus placebo for each). Differences in ADHD-RS-IV total scores favored all LDX doses versus placebo at all weeks (p ≤ .0076). On the CGI-I, 69.1% of participants were rated very much/much improved at endpoint with LDX all doses versus placebo (39.5%) (p < .0001). YQOL-R changes at endpoint scores for LDX groups versus placebo were not significant. Commonly reported LDX (all doses combined) TEAEs (≥5%) were decreased appetite, headache, insomnia, decreased weight, and irritability. Small mean increases in pulse and blood pressure and no clinically meaningful trends in ECG changes were noted with LDX.Conclusions LDX at all doses was effective versus placebo in treating adolescent ADHD and demonstrated a safety profile consistent with previous LDX studies. CLINICAL TRIALS REGISTRY INFORMATION: Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD); http://www.clinicaltrials.gov; NCT00735371.
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Risk of bias was low in the randomized studies of Findling et al. (2011), Newcorn et al. (2017b), and Spencer et al. (2006), and high in all other studies.
“We rated the risk of bias as low in the randomized studies of Findling et al. (2011) [42], Newcorn et al. (2017b) [34], and Spencer et al. (2006) [25], and as high in all other studies (Table 2).”
From Treatment of Adolescents with Concurrent Substance Use Disorder and Attention-Deficit/Hyperactivity Disorder: A Systematic Review (2021) · cites this paper as [42]
RCTs showed efficacy and tolerability of LDX in child and adolescent ADHD, but each trial had a limited sample size.
“Although randomized controlled trials (RCTs) showed the efficacy and tolerability of LDX in child and adolescent ADHD,10–13 each trial had a limited sample size.”
From Comparative efficacy, acceptability, and tolerability of lisdexamfetamine in child and adolescent ADHD: a meta-analysis of randomized, controlled trials (2015) · cites this paper as [11]
Previous studies documented that LDX was an effective, safe, and well-tolerated stimulant in the treatment of ADHD in children and adolescents.
“Previous studies documented that LDX was an effective, safe, and well-tolerated stimulant in the treatment of ADHD in children and adolescents.10–13”
From Comparative efficacy, acceptability, and tolerability of lisdexamfetamine in child and adolescent ADHD: a meta-analysis of randomized, controlled trials (2015) · cites this paper as [11]
In a 4-week randomized controlled trial of 314 adolescents with ADHD, lisdexamfetamine did well across all doses (30 mg, 50 mg, and 70 mg) compared with placebo, as evidenced by improvement in scores on ADHD-RS-IV, CGI, and Youth Quality of Life-Research Version.
“In a 4-week, randomized, controlled trial26 involving 314 adolescents with ADHD who were randomized to receive placebo or to be part of a forced titration arm of lisdexamfetamine (30 mg, 50 mg, and 70 mg), lisdexamfetamine did well across all of the doses in comparison with placebo, as evidenced by improvement in scores on the ADHD-RS-IV, CGI, and Youth Quality of Life-Research Version.”
From Update on optimal use of lisdexamfetamine in the treatment of ADHD (2013) · cites this paper as [26]
A previously reported 4-week randomized, double-blind, placebo-controlled trial of LDX reported greater improvement in ADHD symptoms from baseline on ADHD-RS-IV total score at the end of the study versus placebo.
“A previously reported 4 week, randomized, double-blind, placebo-controlled trial (Findling et al. 2011) of lisdexamfetamine dimesylate (LDX), a long-acting prodrug stimulant indicated for ADHD in children (ages 6–12 years), adolescents (ages 13–17 years), and adults, reported greater improvement in ADHD symptoms from baseline on Attention-Deficit/Hyperactivity Disorder Rating Scale IV (ADHD-RS-IV)”
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 Findling et al. 2011
In the previously reported 4-week trial, greater improvements were not detected in participant-perceived QOL based on the YQOL-R for any LDX dose versus placebo.
“However, greater improvements were not detected in participant-perceived QOL based on the Youth QOL-Research Version (YQOL-R) for any LDX dose (mean [SD] baseline value across doses: 79.5 [12.24]; mean end-point value across doses: 81.2 [12.53]) versus placebo (mean baseline value: 79.2 [11.08]; mean end-point value: 81.3 [12.16]).”
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 Findling et al. 2011
In the short-term antecedent trial with 4 weeks of forced-dose titration LDX, YQOL-R total and domain scores showed small improvements that were not statistically significantly different from those seen with placebo.
“This contrasts with QOL findings from the short-term antecedent trial, with 4 weeks of forced-dose titration LDX, in which YQOL-R total and domain scores at week 52/ET showed small improvements that were not statistically significantly different from those seen with placebo (Findling 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 Findling et al. 2011
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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Self-citationLisdexamfetamine Dimesylate: A New Therapeutic Option for Attention-Deficit Hyperactivity Disorder
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Update on optimal use of lisdexamfetamine in the treatment of ADHD
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Self-citation
- Authors
- Findling, R. L., Childress, A. C., Cutler, A. J., Gasior, M., Hamdani, M., Ferreira-Cornwell, M. C., & Squires, L.
- Affiliations
- University Hospitals Cleveland Medical Center (US)
- Center for Psychiatry and Behavioral Medicine (US)
- Meridien Research (US)
- Takeda (United States) (US)
- Corresponding author
- Findling, Robert L.
- Venue
- Journal of the American Academy of Child & Adolescent Psychiatry
- Publisher
- Elsevier BV
- Published
- 2011-04
- Volume
- 50
- Issue
- 4
- Pages
- 395-405
- ISSN
- 0890-8567 (ISSN-L)
- OpenAlex
- W2131679908
- Semantic Scholar
- 4370a237322b453468db47a43a9e11913e066986
- Cited by
- 120
- References
- 40
- Citations by year
- 2026: 1 · 2025: 7 · 2024: 3 · 2023: 2 · 2022: 5 · 2021: 6 · 2020: 7 · 2019: 2 · 2018: 7 · 2017: 11 · 2016: 9 · 2015: 10 · 2014: 19 · 2013: 13 · 2012: 12
- FWCI
- 10.57
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of the American Academy of Child & Adolescent 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 › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Keywords
- lisdexamfetamine dimesylate, attention deficit hyperactivity disorder, adolescents, stimulant medication, ADHD-RS-IV, treatment-emergent adverse events, dose titration, quality of life, cardiovascular safety, electrocardiographic changes, appetite loss, irritability, weight loss, ADHD medication, stimulants
- MeSH terms
- Lisdexamfetamine Dimesylate, Adolescent, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Dextroamphetamine, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Personality Assessment, Psychometrics, Quality of Life, United States, Treatment Outcome, Drug-Related Side Effects and Adverse Reactions
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