Correlation of symptomatic improvements with functional improvements and patient-reported outcomes in adults with attention-deficit/hyperactivity disorder treated with OROS methylphenidate

Abstract

Objectives. To evaluate correlations between symptom severity and daily functioning in adults with ADHD. Methods. In the 5-week, double-blind LAMDA study, 401 adults with ADHD were randomly assigned to Osmotic-Release Oral System (OROS) methylphenidate (MPH) 18, 36 or 72 mg/day, or placebo. The primary variable – investigator-rated Conners’ Adult ADHD Rating Scale (CAARS:O-SV) – has been presented previously. Secondary endpoints included the self-reported version of CAARS (CAARS-S:S) and Clinical Global Impression – Severity (CGI-S). Daily functioning and quality of life were assessed using the Sheehan Disability Scale (SDS) and Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q). Relationships between symptom and functional outcomes were evaluated in post-hoc Pearson partial correlation, multivariate regression and mediator analyses. Results. Improvements in CAARS-S:S, CGI-S and SDS scores were significantly greater in each OROS MPH arm versus placebo (P < 0.01 for all comparisons). Correlations between symptom and functioning scores were significant for all comparisons (P < 0.0001). In regression analyses, CAARS Hyperactivity/Impulsivity subscale and CGI-S were correlated with SDS (P < 0.05). CAARS Inattention was correlated with the SDS Family Life domain (P < 0.05). In a mediator analysis, the impact of treatment on SDS scores was fully mediated by improvement in CAARS:O-SV score. Conclusions. OROS MPH 18–72 mg/day was associated with significant improvements in ADHD symptoms, which correlated with improved daily functioning and health-related quality of life.

Key words::

• Adults
• attention-deficit/hyperactivity disorder
• daily functioning
• OROS methylphenidate
• health-related quality of life

Acknowledgements

This study was supported by Janssen–Cilag EMEA (Europe, Middle East & Africa) Editorial support with the drafting and completion of this manuscript was provided by Daniel Booth PhD (Bioscript Stirling Ltd, London, UK) and funded by Janssen–Cilag EMEA.

Statement of Interest

M. Rösler is a consultant for Janssen–Cilag, Medice, Lilly and Shire, and is a member of the speaker's bureau of Janssen–Cilag, Medice and Shire. Y. Ginsberg has been on the speaker's bureau and is a consultant for Janssen–Cilag, Novartis and Lundbeck, and was the principal investigator of the LAMDA and LAMDA-II trials sponsored by Janssen–Cilag EMEA. T. Arngrim was an investigator in the LAMDA trial sponsored by Janssen–Cilag EMEA, has been an Advisory Board member for Novartis, Shire and Astra Zeneca, and has been a speaker on ADHD for Novartis, Lilly, BMS, Astra Zeneca and Medice. M. Adamou declares no conflict of interest. A. Niemelä declares no conflict of interest. J. Dejonkheere is an employee of SGS–Life Science Services, a company employed by Janssen–Cilag EMEA to provide statistical analysis. J. van Oene is a former employee of Janssen–Cilag EMEA. B. Schäuble is an employee of Janssen–Cilag EMEA.