Self-Reported quality of life in adults with attention-deficit/hyperactivity disorder and executive function impairment treated with lisdexamfetamine dimesylate: a randomized, double-blind, multicenter, placebo-controlled, parallel-group study

BMC Psychiatry

Richard Weisler⁴  Keith Saylor¹  Matthew Dauphin²  Aparna Raychaudhuri²  Patrick Deas²  Bryan Dirks²  Lenard A Adler³ 

[1] NeuroScience, Inc., Herndon, VA, USA;Clinical Development and Medical Affairs, Shire Development LLC, Wayne, PA, USA;Department of Psychiatry and Child and Adolescent Psychiatry, New York University School of Medicine and Psychiatry Service, New York VA Harbor Healthcare System, New York, NY, USA;University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

关键词: Executive function;    Quality of life;    ADHD;    LDX;    Lisdexamfetamine dimesylate;   

Others  :  1123941
DOI  :  10.1186/1471-244X-13-253

 received in 2013-01-24, accepted in 2013-09-06,  发布年份 2013

【 摘 要 】

Background

This study examined the effects of lisdexamfetamine dimesylate (LDX) on quality of life (QOL) in adults with attention-deficit/hyperactivity disorder (ADHD) and clinically significant executive function deficits (EFD).

Methods

This report highlights QOL findings from a 10-week randomized placebo-controlled trial of LDX (30–70 mg/d) in adults (18–55 years) with ADHD and EFD (Behavior Rating Inventory of EF-Adult, Global Executive Composite [BRIEF-A GEC] ≥65). The primary efficacy measure was the self-reported BRIEF-A; a key secondary measure was self-reported QOL on the Adult ADHD Impact Module (AIM-A). The clinician-completed ADHD Rating Scale version IV (ADHD-RS-IV) with adult prompts and Clinical Global Impressions-Severity (CGI-S) were also employed. The Adult ADHD QoL (AAQoL) was added while the study was in progress. A post hoc analysis examined the subgroup having evaluable results from both AIM-A and AAQoL.

Results

Of 161 randomized (placebo, 81; LDX, 80), 159 were included in the safety population. LDX improved AIM-A multi-item domain scores versus placebo; LS mean difference for Performance and Daily Functioning was 21.6 (ES, 0.93, P<.0001); Impact of Symptoms: Daily Interference was 14.9 (ES, 0.62, P<.0001); Impact of Symptoms: Bother/Concern was 13.5 (ES, 0.57, P=.0003); Relationships/Communication was 7.8 (ES, 0.31, P=.0302); Living With ADHD was 9.1 (ES, 0.79, P<.0001); and General Well-Being was 10.8 (ES, 0.70, P<.0001). AAQoL LS mean difference for total score was 21.0; for subscale: Life Productivity was 21.0; Psychological Health was 12.1; Life Outlook was 12.5; and Relationships was 7.3. In a post hoc analysis of participants with both AIM-A and AAQoL scores, AIM-A multi-item subgroup analysis scores numerically improved with LDX, with smaller difference for Impact of Symptoms: Daily Interference. The safety profile of LDX was consistent with amphetamine use in previous studies.

Conclusions

Overall, adults with ADHD/EFD exhibited self-reported improvement on QOL, using the AIM-A and AAQoL scales in line with medium/large ES; these improvements were paralleled by improvements in EF and ADHD symptoms. The safety profile of LDX was similar to previous studies.

Trial registration

ClinicalTrials.gov, NCT01101022

【 授权许可】

   
2013 Adler et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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