Thomas E Brown1, Jeanne M Landgraf. 1. Department of Psychiatry, Yale University School of Medicine, Yale Clinic for Attention and Related Disorders, 1188 Whitney Ave., New Haven, Hamden, CT 06517, USA. tebrownyu@aol.com
Abstract
OBJECTIVE: To assess whether improvement in executive function correlates with perceived improvement in health-related quality of life (HRQOL) in adults with attention-deficit/hyperactivity disorder (ADHD) who are treated with stimulant medication. METHODS: We collected data on executive function and HRQOL using the Brown Attention-Deficit Disorder Scale (BADDS) and the ADHD Impact Module-Adult (AIM-A) during 2 large, randomized, double-blind, placebo-controlled trials evaluating the use of the triple-bead mixed amphetamine salt (MAS) SPD465 as stimulant pharmacotherapy for ADHD. BADDS and AIM-A data were collected at baseline and at study endpoint, and changes from baseline were assessed. Correlation coefficients for BADDS and AIM-A were calculated at baseline and endpoint for each study. RESULTS: The change from baseline in BADDS total score was -14.8 ± 24.49 in Study 1 (dose optimization strategy) and -26.1 ± 28.54 in Study 2 (forced-dose titration strategy), demonstrating substantial reported improvement in executive function. In both studies, improvement was reported for all 5 BADDS clusters at study endpoint versus baseline. While improvement was reported for all 6 AIM-A scales at study endpoint versus baseline, the most substantial change from baseline in AIM-A scores over the course of the studies was in Performance and Function (Study 1, +15.2 ± 25.68; Study 2, +26.3 ± 28.17). There was significant correlation of the BADDS total score with the AIM-A Performance and Function scale (Study 1, -0.6723; Study 2, -0.6982), and strong correlations were observed between each of the 5 individual clusters of BADDS and AIM-A performance and function in both studies. CONCLUSIONS: Reported improvement in executive function correlates with reported improvement in HRQOL as assessed in 2 independent clinical trials in which participants received either placebo or triple-bead MAS for the treatment of ADHD. In particular, there were strong correlations between all 5 individual clusters of BADDS and the AIM-A Performance and Function scale.
RCT Entities:
OBJECTIVE: To assess whether improvement in executive function correlates with perceived improvement in health-related quality of life (HRQOL) in adults with attention-deficit/hyperactivity disorder (ADHD) who are treated with stimulant medication. METHODS: We collected data on executive function and HRQOL using the Brown Attention-Deficit Disorder Scale (BADDS) and the ADHD Impact Module-Adult (AIM-A) during 2 large, randomized, double-blind, placebo-controlled trials evaluating the use of the triple-bead mixed amphetamine salt (MAS) SPD465 as stimulant pharmacotherapy for ADHD. BADDS and AIM-A data were collected at baseline and at study endpoint, and changes from baseline were assessed. Correlation coefficients for BADDS and AIM-A were calculated at baseline and endpoint for each study. RESULTS: The change from baseline in BADDS total score was -14.8 ± 24.49 in Study 1 (dose optimization strategy) and -26.1 ± 28.54 in Study 2 (forced-dose titration strategy), demonstrating substantial reported improvement in executive function. In both studies, improvement was reported for all 5 BADDS clusters at study endpoint versus baseline. While improvement was reported for all 6 AIM-A scales at study endpoint versus baseline, the most substantial change from baseline in AIM-A scores over the course of the studies was in Performance and Function (Study 1, +15.2 ± 25.68; Study 2, +26.3 ± 28.17). There was significant correlation of the BADDS total score with the AIM-A Performance and Function scale (Study 1, -0.6723; Study 2, -0.6982), and strong correlations were observed between each of the 5 individual clusters of BADDS and AIM-A performance and function in both studies. CONCLUSIONS: Reported improvement in executive function correlates with reported improvement in HRQOL as assessed in 2 independent clinical trials in which participants received either placebo or triple-bead MAS for the treatment of ADHD. In particular, there were strong correlations between all 5 individual clusters of BADDS and the AIM-A Performance and Function scale.
Authors: C Neill Epperson; Sheila Shanmugan; Deborah R Kim; Sarah Mathews; Kathryn A Czarkowski; Jeanette Bradley; Dina H Appleby; Claudia Iannelli; Mary D Sammel; Thomas E Brown Journal: Psychopharmacology (Berl) Date: 2015-06-11 Impact factor: 4.530
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