EFFECTS OF LISDEXAMFETAMINE DIMESYLATE AUGMENTATION ON FUNCTIONAL OUTCOMES IN ADULTS WITH PARTIALLY OR FULLY REMITTED MAJOR DEPRESSIVE DISORDER
Author(s)
Supina D1, Endicott J2, Madhoo M1, Keefe RSE3, Trivedi M4, Wu J1, Scheckner B1, Lasser R11Shire Development, LLC, Wayne, PA, USA, 2Columbia University; New York State Psychiatric Institute, New York, NY, USA, 3Duke University Medical Center, Durham, NC, USA, 4University of Texas Southwestern Medical School, Dallas, TX, USA
OBJECTIVES: In adults with executive dysfunction and mild major depressive disorder (MDD), lisdexamfetamine dimesylate (LDX) augmentation significantly improved executive dysfunction (primary endpoint) on the Behavior Rating Inventory of Executive Function–Adult Version (BRIEF-A). Because cognitive impairment can affect functioning, including the ability to work, we describe LDX effects on functional outcomes from the aforementioned study. METHODS: This double-blind, placebo-controlled study enrolled participants (18–55 y) with mild MDD (Montgomery-Åsberg Depression Rating Scale total score ≤18) and executive dysfunction (BRIEF-A Global Executive Composite T-score ≥60) on stable SSRI monotherapy for ≥8 weeks. After 2 weeks of screening, participants were randomized to 9 weeks of double-blind LDX (week 1: 20 mg/d; weeks 2–6: maintain or increase LDX in 10-mg increments weekly to 70 mg/d; weeks 7–9: maintain optimized dose) or placebo augmentation, followed by 2 weeks of single-blind placebo. Prespecified secondary functional endpoints included the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) and Endicott Work Productivity Scale (EWPS). Analyses included analysis of covariance in randomized participants who took ≥1 study drug dose and had ≥1 postbaseline BRIEF-A assessment. RESULTS: Of 143 randomized participants (placebo, 72; LDX, 71), 119 completed double-blind treatment (placebo, 59; LDX, 60). For the Q-LES-Q, least squares (LS) mean (95% CI) treatment differences at endpoint significantly favored LDX in 5 of 10 domains: “physical health activities” (9.6 [3.6, 15.6]; P=0.0020), “feelings” (5.8 [0.0, 11.6]; P=0.0481), “work” (9.1 [2.0, 16.1]; P=0.0123), “household duties” (8.8 [2.2, 15.4]; P=0.0094), and “general activities” (6.2 [1.0, 11.4]; P=0.0191); no differentiation was observed in the other domains. For the EWPS, the LS mean (95% CI) treatment difference at endpoint numerically favored LDX but was not statistically significant (–4.4 [–10.9, 2.0; P=0.1731). CONCLUSIONS: These findings suggest LDX augmentation modestly improves functional outcomes in adults with partially or fully remitted MDD.
Conference/Value in Health Info
2012-06, ISPOR 2012, Washington, D.C., USA
Value in Health, Vol. 15, No. 4 (June 2012)
Code
PMH61
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Mental Health