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Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design.
Behav Brain Funct 2010; 6:34BB

Abstract

BACKGROUND

Duration of efficacy and safety of lisdexamfetamine dimesylate (LDX) was assessed in adults (18-55 years) with attention-deficit/hyperactivity disorder (ADHD) using the simulated adult workplace environment.

METHODS

After open-label dose optimization (4-week) with LDX, 30-70 mg/d, subjects entered a 2-week randomized, double-blind, placebo-controlled crossover phase. Efficacy assessments included the Permanent Product Measure of Performance (PERMP) total score (attempted+correct) measured predose and from 2 to 14 hours postdose, averaged across postdose sessions (primary) and at each time point vs placebo (secondary), and ADHD Rating Scale IV (ADHD-RS-IV) with adult prompts at baseline and crossover visits. Safety assessments included treatment-emergent adverse events (TEAEs), vital signs, and electrocardiograms.

RESULTS

Of 127 randomized subjects, 105 were in the intention-to-treat population and 103 completed the study. While receiving LDX vs placebo, adults had greater improvement (P < .0001) in average PERMP total scores as measured by difference in least squares (LS) mean (95% CI): 23.4 (15.6, 31.2). Absolute (P <or= .0017 for each time point) and change from predose (P < .001 for each time point) PERMP total scores were greater at all postdose time points from 2 to 14 h for adults while receiving LDX vs placebo. LDX demonstrated efficacy vs placebo (P < .0001) by the difference in LS mean (95% CI) for ADHD-RS-IV total scores: -11.5 (-14.2, -8.9). TEAEs (>or=10%) during dose optimization were decreased appetite, dry mouth, headache, and insomnia; no TEAEs >or=5% were reported during crossover phase for adults receiving LDX.

CONCLUSIONS

LDX significantly improved PERMP scores vs placebo and maintained improvement throughout the day from the first (2 hours) to last (14 hours) postdose time point vs placebo in adults with ADHD.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT00697515. Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) http://www.clinicaltrials.gov/ct2/show/NCT00697515?term=NCT00697515&rank=1.

Authors+Show Affiliations

Department of Pediatrics, University of California, Irvine, Child Development Center, Irvine, CA, USA. tlwigal@uci.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20576091

Citation

Wigal, Timothy, et al. "Randomized, Double-blind, Placebo-controlled, Crossover Study of the Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Attention-deficit/hyperactivity Disorder: Novel Findings Using a Simulated Adult Workplace Environment Design." Behavioral and Brain Functions : BBF, vol. 6, 2010, p. 34.
Wigal T, Brams M, Gasior M, et al. Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design. Behav Brain Funct. 2010;6:34.
Wigal, T., Brams, M., Gasior, M., Gao, J., Squires, L., & Giblin, J. (2010). Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design. Behavioral and Brain Functions : BBF, 6, p. 34. doi:10.1186/1744-9081-6-34.
Wigal T, et al. Randomized, Double-blind, Placebo-controlled, Crossover Study of the Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Attention-deficit/hyperactivity Disorder: Novel Findings Using a Simulated Adult Workplace Environment Design. Behav Brain Funct. 2010 Jun 24;6:34. PubMed PMID: 20576091.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, double-blind, placebo-controlled, crossover study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder: novel findings using a simulated adult workplace environment design. AU - Wigal,Timothy, AU - Brams,Matthew, AU - Gasior,Maria, AU - Gao,Joseph, AU - Squires,Liza, AU - Giblin,John, AU - ,, Y1 - 2010/06/24/ PY - 2009/12/30/received PY - 2010/06/24/accepted PY - 2010/6/26/entrez PY - 2010/6/26/pubmed PY - 2010/10/21/medline SP - 34 EP - 34 JF - Behavioral and brain functions : BBF JO - Behav Brain Funct VL - 6 N2 - BACKGROUND: Duration of efficacy and safety of lisdexamfetamine dimesylate (LDX) was assessed in adults (18-55 years) with attention-deficit/hyperactivity disorder (ADHD) using the simulated adult workplace environment. METHODS: After open-label dose optimization (4-week) with LDX, 30-70 mg/d, subjects entered a 2-week randomized, double-blind, placebo-controlled crossover phase. Efficacy assessments included the Permanent Product Measure of Performance (PERMP) total score (attempted+correct) measured predose and from 2 to 14 hours postdose, averaged across postdose sessions (primary) and at each time point vs placebo (secondary), and ADHD Rating Scale IV (ADHD-RS-IV) with adult prompts at baseline and crossover visits. Safety assessments included treatment-emergent adverse events (TEAEs), vital signs, and electrocardiograms. RESULTS: Of 127 randomized subjects, 105 were in the intention-to-treat population and 103 completed the study. While receiving LDX vs placebo, adults had greater improvement (P < .0001) in average PERMP total scores as measured by difference in least squares (LS) mean (95% CI): 23.4 (15.6, 31.2). Absolute (P <or= .0017 for each time point) and change from predose (P < .001 for each time point) PERMP total scores were greater at all postdose time points from 2 to 14 h for adults while receiving LDX vs placebo. LDX demonstrated efficacy vs placebo (P < .0001) by the difference in LS mean (95% CI) for ADHD-RS-IV total scores: -11.5 (-14.2, -8.9). TEAEs (>or=10%) during dose optimization were decreased appetite, dry mouth, headache, and insomnia; no TEAEs >or=5% were reported during crossover phase for adults receiving LDX. CONCLUSIONS: LDX significantly improved PERMP scores vs placebo and maintained improvement throughout the day from the first (2 hours) to last (14 hours) postdose time point vs placebo in adults with ADHD. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00697515. Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD) http://www.clinicaltrials.gov/ct2/show/NCT00697515?term=NCT00697515&rank=1. SN - 1744-9081 UR - https://www.unboundmedicine.com/medline/citation/20576091/Randomized_double_blind_placebo_controlled_crossover_study_of_the_efficacy_and_safety_of_lisdexamfetamine_dimesylate_in_adults_with_attention_deficit/hyperactivity_disorder:_novel_findings_using_a_simulated_adult_workplace_environment_design_ L2 - https://behavioralandbrainfunctions.biomedcentral.com/articles/10.1186/1744-9081-6-34 DB - PRIME DP - Unbound Medicine ER -