Key result
Levomilnacipran ER significantly increased the concurrent resolution of all 10 MADRS items compared to placebo (11.2% vs 7.8%, OR 1.57) in adults with major depressive disorder.
Why the study?
Does levomilnacipran ER improve individual depression symptoms and symptom domains in adults with major depressive disorder compared to placebo?
Does levomilnacipran ER improve individual depression symptoms and symptom domains in adults with major depressive disorder compared to placebo?
Odds Ratio: 1.57
Absolute Event Rate: 11.2% vs 7.8%
Absolute Risk Reduction: 3.4%
p-value: p=0.0051
Levomilnacipran ER significantly improves a broad range of individual depression symptoms and symptom clusters compared to placebo in adults with major depressive disorder.
Supports levomilnacipran ER for broad MDD symptom relief; extends RCT evidence to concurrent resolution across all MADRS items.
OBJECTIVE: A post hoc analysis evaluated the effects of levomilnacipran ER on individual symptoms and symptom domains in adults with major depressive disorder (MDD). METHODS: Data were pooled from 5 Phase III trials comprising 2598 patients. Effects on depression symptoms were analyzed based on change from baseline in individual Montgomery-Åsberg Depression Rating Scale (MADRS) item scores. A1dditional evaluations included resolution of individual symptoms (defined as a MADRS item score ≤1 at end of treatment) and concurrent resolution of all 10 MADRS items, all MADRS6 subscale items, and all items included in different symptom clusters (Dysphoria, Retardation, Vegetative Symptoms, Anhedonia). RESULTS: Significantly greater mean improvements were found on all MADRS items except Reduced Appetite with levomilnacipran ER treatment compared with placebo. Resolution of individual symptoms occurred more frequently with levomilnacipran ER than placebo for each MADRS item (all P<.05), with odds ratios (ORs) ranging from 1.26 to 1.75; resolution of all 10 items was also greater with levomilnacipran ER (OR=1.57; P=.0051). Significant results were found for the MADRS6 subscale (OR=1.73; P<.0001) and each symptom cluster (OR range, 1.39 [Vegetative Symptoms] to 1.84 [Retardation]; all clusters, P<.01). CONCLUSION: Adult MDD patients treated with levomilnacipran ER improved across a range of depression symptoms and symptom domains.
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McIntyre et al. (2016) studied Major depressive disorder (MDD) (n=2,598). Levomilnacipran ER vs. Placebo was evaluated on Concurrent resolution of all 10 MADRS items (defined as score ≤1 for each item) (OR 1.57, p=0.0051). Levomilnacipran ER significantly increased the concurrent resolution of all 10 MADRS items compared to placebo (11.2% vs 7.8%, OR 1.57) in adults with major depressive disorder.
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