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Randomized Controlled Trial
. 2014 May;24(4):210-7.
doi: 10.1089/cap.2013.0077. Epub 2014 May 9.

Participant-perceived quality of life in a long-term, open-label trial of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder

Ann C Childress  1 , Andrew J Cutler, Keith Saylor, Maria Gasior, Mohamed Hamdani, M Celeste Ferreira-Cornwell, Robert L Findling
Affiliations
Randomized Controlled Trial

Participant-perceived quality of life in a long-term, open-label trial of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder

Ann C Childress et al. J Child Adolesc Psychopharmacol. 2014 May.

Abstract

Objectives: The purpose of this study was to assess long-term improvement in quality of life (QOL) in adolescents with attention-deficit/hyperactivity disorder (ADHD) treated with lisdexamfetamine dimesylate (LDX).

Methods: Adolescents with ADHD treated for ≥3 weeks in a 4 week, placebo-controlled study entered a 1 year, open-label study. After the 4 week dose optimization (30, 50, and 70 mg/day LDX) period, treatment was maintained for 48 additional weeks. Change from baseline (of prior study) to week 52/early termination (ET) (of open-label study) in ADHD Rating Scale IV (ADHD-RS-IV) assessed effectiveness, and the Youth QOL-Research Version (YQOL-R) assessed participant-perceived QOL. Post-hoc analyses described effectiveness and QOL for participants with self-perceived poor QOL at baseline (≥1 SD below the mean) versus all others, and for study completers versus study noncompleters.

Results: These post-hoc analyses included 265 participants. Participants with baseline self-perceived poor QOL (n=32) versus all others (n=232) exhibited robust YQOL-R perceptual score changes (improvement) with LDX, emerging by week 28 and maintained to week 52/ET. Week 52/ET mean change score ranged from +9.8 to +17.6 for participants with baseline self-perceived poor QOL and +0.4 to +5.1 for all others; week 52/ET improvements in ADHD-RS-IV total scores were similar, regardless of baseline YQOL-R total score. At week 52/ET, study completers had greater YQOL-R improvements than did noncompleters; ADHD-RS-IV total score changes were also numerically larger at week 52/ET for completers than for noncompleters.

Conclusion: 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.

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Figures

<b>FIG. 1.</b>
FIG. 1.
Mean (SD) ADHD-RS-IV total score in the full analysis set at baselinea and change from baseline scoreb stratified by (A) transformed participant-perceived QOL at baseline or (B) completersc versus noncompletersd of the current study. aBaseline score is based on the baseline of the antecedent 4 week study. bChange from baseline for study completers was assessed at week 52 and for noncompleters at ET. cStudy completers=participants who completed the current study. dStudy noncompleters=participants who did not complete the current study. ADHD-RS-IV, Attention-Deficit/Hyperactivity Disorder Rating Scale IV; ET, early termination; QOL, quality of life.
See this image and copyright information in PMC

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