A Long-Term Open-Label Safety and Effectiveness Trial of Lisdexamfetamine Dimesylate in Adolescents With Attention-Deficit/Hyperactivity Disorder
Abstract
Objective Information on psychostimulant treatment in long-term studies for attention-deficit/hyperactivity disorder (ADHD) in adolescents is limited. This study aimed to assess the safety and effectiveness of lisdexamfetamine dimesylate (LDX) over 52 weeks in adolescents with ADHD. Methods This open-label multicenter study enrolled eligible participants after their participation in a randomized, double-blind, placebo-controlled 4 week trial in adolescents with ADHD. Following a 4 week dose-optimization phase, participants were maintained on treatment for up to ∼48 weeks on an optimal dose. Safety assessments included treatment-emergent adverse events (TEAEs), vital signs, laboratory findings, and electrocardiograms. Effectiveness measures included the ADHD Rating Scale IV (ADHD-RS-IV; primary) and Clinical Global Impressions-Improvement (CGI-I). The Youth Quality of Life-Research Version (YQOL-R) was also included in this study; raw scores are transformed to a 0-100 point scale. Results Of 269 enrolled (from the antecedent study), 265 (98.5%) were in the safety population and effectiveness population. Common TEAEs (≥5%) with LDX included upper respiratory tract infection (21.9%), decreased appetite (21.1%), headache (20.8%), decreased weight (16.2%), irritability (12.5%), insomnia (12.1%), nasopharyngitis (7.2%), influenza (6.8%), dizziness (5.3%), and dry mouth (5.3%). At end point, for all LDX doses in the overall safety population, mean (SD) increase from baseline in syst…
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In adolescents with ADHD treated with lisdexamfetamine dimesylate in this 52-week open-label extension, ADHD symptoms (ADHD-RS-IV total score) improved from baseline to week 52/early termination.
“Participant-perceived QOL and ADHD symptoms improved from baseline with LDX in adolescents with ADHD; greatest improvements occurred among participants with baseline self-perceived poor QOL.”
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. 2013
In adolescents with ADHD treated with lisdexamfetamine dimesylate in this 52-week open-label extension, participant-perceived quality of life (YQOL-R perceptual total score) improved from baseline to week 52/early termination.
“Participant-perceived QOL and ADHD symptoms improved from baseline with LDX in adolescents with ADHD; greatest improvements occurred among participants with baseline self-perceived poor QOL.”
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. 2013
In the overall study population, statistically significant improvements in transformed YQOL-R total and domain scores were seen at week 52/ET, with the largest improvements in the self and environment domains.
“For the overall study population, significant improvements in transformed YQOL-R total and domain scores were seen at week 52/ET, with the largest improvements reported for the self and environment domains (Findling et al. 2013).”
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. 2013
A 0.5 SD change from the baseline mean transformed YQOL-R perceptual total score corresponds to approximately 5.5 points.
“Therefore, when interpreting the YQOL-R changes observed in this study, a 0.5 SD change from the baseline mean transformed YQOL-R perceptual total score corresponds to ∼5.5 points (Findling et al. 2013).”
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. 2013
At week 52/ET, the mean (SD) transformed YQOL-R perceptual total score of the overall population was 83.9 (11.00).
“At week 52/ET of the current study, the mean (SD) transformed YQOL-R perceptual total score of 83.9 (11.00) for the overall population (Findling et al. 2013) was somewhat higher than, but generally comparable with, the estimated marginal mean score in individuals without a self-reported chronic condition in the validation study (Patrick et al. 2002).”
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. 2013
The mean (SD) baseline transformed YQOL-R perceptual total score in the overall population was 79.8 (11.28).
“In the current study, the mean (SD) baseline transformed YQOL-R perceptual total score in the overall population was 79.8 (11.28) (Findling et al. 2013), which is numerically higher than the estimated marginal mean (SE) scores observed in individuals with ADHD (75.19 [1.48]) in the initial validation study of the YQOL-R, but numerically lower than was observed in individuals with no self-reported”
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. 2013
Cites
Pliszka, S. (2007) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/chi.0b013e318054e724 · Cited by 1,765 · see citing works
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
Does Prolonged Therapy With a Long-Acting Stimulant Suppress Growth in Children With ADHD?
SPENCER, T. J., FARAONE, S. V., BIEDERMAN, J., LERNER, M., COOPER, K. M., & ZIMMERMAN, B. (2006) · Journal of the American Academy of Child & Adolescent Psychiatry · doi:10.1097/01.chi.0000205710.01690.d4 · Cited by 125 · see citing works
Weisler, 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
Hammerness, P., Wilens, T., Mick, E., Spencer, T., Doyle, R., McCreary, M., Becker, J., & Biederman, J. (2009) · The Journal of Pediatrics · doi:10.1016/j.jpeds.2009.02.008 · Cited by 57 · see citing works
Childress, A. C., Spencer, T., Lopez, F., Gerstner, O., Thulasiraman, A., Muniz, R., & Post, A. (2009) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2009.0007 · Cited by 34 · see citing works
Self-citationDiagnosis of Attention-Deficit/Hyperactivity Disorder: Technical Review Number 3: (579532012-001)
Green, M., Wong, M., Atkins, D., Taylor, J., & Feinleib, M. (1999) · PsycEXTRA Dataset · doi:10.1037/e579532012-001 · Cited by 17 · see citing works
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Coghill, D. R., Banaschewski, T., Nagy, P., Otero, I. H., Soutullo, C., Yan, B., Caballero, B., & Zuddas, A. (2017) · CNS Drugs · doi:10.1007/s40263-017-0443-y · Cited by 45 · see citing works
Luan, R., Mu, Z., Yue, F., & He, S. (2017) · Frontiers in Psychiatry · doi:10.3389/fpsyt.2017.00229 · Cited by 11 · see citing works
Childress, A. C., Cutler, A. J., Saylor, K., Gasior, M., Hamdani, M., Ferreira-Cornwell, M. C., & Findling, R. L. (2014) · Journal of Child and Adolescent Psychopharmacology · doi:10.1089/cap.2013.0077 · Cited by 5 · see citing works
Self-citation
- Authors
- Findling, R. L., Cutler, A. J., Saylor, K., Gasior, M., Hamdani, M., Ferreira-Cornwell, M. C., & Childress, A. C.
- Affiliations
- Kennedy Krieger Institute (US)
- University of Florida (US)
- NeuroScience, Inc.
- Shire Development LLC
- Takeda (United States) (US)
- Center for Psychiatry and Behavioral Medicine (US)
- Corresponding author
- Findling, Robert L.
- Venue
- Journal of Child and Adolescent Psychopharmacology
- Publisher
- SAGE Publications
- Published
- 2013-02
- Volume
- 23
- Issue
- 1
- Pages
- 11-21
- ISSN
- 1044-5463 (ISSN-L)
- 1557-8992
- OpenAlex
- W1985935801
- Cited by
- 40
- References
- 7
- Citations by year
- 2026: 3 · 2025: 6 · 2024: 5 · 2020: 3 · 2019: 2 · 2018: 4 · 2017: 6 · 2016: 1 · 2015: 3 · 2014: 4 · 2013: 3
- FWCI
- 2.60
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Child and Adolescent Psychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Keywords
- lisdexamfetamine dimesylate, attention deficit hyperactivity disorder, adolescents, treatment safety, treatment effectiveness, adverse events, blood pressure, quality of life, ADHD Rating Scale-IV, dose optimization, dose titration
- MeSH terms
- Lisdexamfetamine Dimesylate, Adolescent, Adolescent Behavior, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Dextroamphetamine, Female, Humans, Male, Psychiatric Status Rating Scales, Quality of Life
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