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• W2079804712 abstract "Evaluate lisdexamfetamine dimesylate (LDX) augmentation of antidepressant monotherapy for executive dysfunction in partially or fully remitted major depressive disorder (MDD). This randomized, placebo-controlled study (NCT00985725) enrolled 143 adults (18–55 years) with mild MDD (Montgomery-Åsberg Depression Rating Scale (MADRS) score ⩽18) and executive dysfunction (Behavior Rating Inventory of Executive Function-Adult Version (BRIEF-A) Self-Report Global Executive Composite (GEC) T score ⩾60) on stable antidepressant monotherapy for ⩾8 weeks. After 2 weeks of screening, participants were randomized to 9 weeks of double-blind LDX (20–70 mg/day) or placebo augmentation, followed by 2 weeks of single-blind placebo. The primary end point was change from baseline to week 9/end of study (EOS) in BRIEF-A Self-Report GEC T score; secondary assessments included the BRIEF-A Informant Report, MADRS, and treatment-emergent adverse events (TEAEs). Of 143 randomized participants, 119 completed double-blind treatment (placebo, n=59; LDX, n=60). Mean±standard deviation (SD) BRIEF-A GEC T scores decreased from baseline (placebo, 74.2±8.88; LDX, 76.8±9.66) to week 9/EOS (placebo, 61.4±14.61; LDX, 55.2±16.15); the LS mean (95% CI) treatment difference significantly favored LDX (−8.0 (−12.7, −3.3); P=0.0009). The LS mean (95% CI) treatment difference for MADRS total score also significantly favored LDX (−1.9 (−3.7, 0.0); P=0.0465). TEAE rates were 73.6% with placebo and 78.9% with LDX; serious TEAE rates were 4.2 and 2.8%. In this trial, LDX augmentation significantly improved executive dysfunction and depressive symptoms in participants with mild MDD. The safety profile of LDX was consistent with prior studies in adults with attention-deficit/hyperactivity disorder." @default.
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• W2079804712 date "2013-12-06" @default.
• W2079804712 modified "2023-09-28" @default.
• W2079804712 title "Lisdexamfetamine Dimesylate Augmentation in Adults With Persistent Executive Dysfunction After Partial or Full Remission of Major Depressive Disorder" @default.
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• W2079804712 doi "https://doi.org/10.1038/npp.2013.334" @default.
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