Desvenlafaxine for the Prevention of Relapse in Major Depressive Disorder: Results of a Randomized Trial
Abstract
OBJECTIVES: To compare the efficacy and safety of desvenlafaxine (administered as desvenlafaxine succinate) with placebo in reducing relapse rate in patients with major depressive disorder (MDD). METHODS: This phase 3, multicenter, randomized trial included a 12-week, open-label (OL) treatment phase (intent-to-treat population, n = 575) followed by a 6-month, double-blind (DB) relapse prevention phase. Patients who responded to the OL treatment (17-item Hamilton Rating Scale for Depression total score or= 16 at any visit, Clinical Global Impression-Improvement score >or= 6 at any visit, or discontinuation due to unsatisfactory response). RESULTS: Patients receiving desvenlafaxine (n = 189) experienced significantly longer times to relapse of MDD versus patients receiving placebo (n = 185) during the DB period (log-rank test, P < 0.0001). The percentages of patients relapsing were 42% (78/185) and 24% (45/189) for placebo and desvenlafaxine, respectively (P < 0.001). The most common primary reason cited for discontinuation in the OL period was adverse events (19%), which consisted of nausea, dizziness, and insomnia. A total of 159 patients (42%) discontinued treatment during the DB period, including 101 placebo- (55%) and 58 desvenlafaxine-treated patients (31%). The most frequent adverse event reported as reason for treatment discontinuation in the DB period was depression, reported by 14 placebo- (8%) and 7 desvenlafaxine-treated patients (4%). CONCLUSIONS: Desvenlafaxine effectively prevented relapse of MDD during 6 months of DB treatment in patients who had responded to 12 weeks of OL desvenlafaxine therapy.
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The results of the first levomilnacipran ER relapse-prevention study are inconsistent with relapse-prevention outcomes reported in the literature for trials of other SNRIs versus placebo (e.g., venlafaxine, 28% vs. 52%; desvenlafaxine, 24% vs. 42%; duloxetine, 21.9% vs. 43.1%).
“the results of the first levomilnacipran ER relapse‐prevention study are inconsistent with relapse‐prevention outcomes reported in the literature for trials of other SNRIs versus placebo (e.g., venlafaxine, 28% vs. 52%; desvenlafaxine, 24% vs. 42%; duloxetine, 21.9% vs. 43.1%; Perahia et al., 2006; Rickels et al., 2010; Simon, Aguiar, Kunz, & Lei, 2004).”
From Relapse prevention with levomilnacipran ER in adults with major depressive disorder: a multicenter, randomized, double-blind, placebo-controlled study (2019) · cites this paper as Rickels et al., 2010
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- Authors
- Rickels, K., Montgomery, S. A., Tourian, K. A., Guelfi, J. D., Pitrosky, B., Padmanabhan, S. K., Germain, J.-M., Leurent, C., & Brisard, C.
- Affiliations
- University of Pennsylvania (US)
- Imperial College London (GB)
- Wyeth (US)
- Centre Hospitalier Sainte-Anne (FR)
- Pfizer (France) (FR)
- Corresponding author
- Rickels, Karl
- Venue
- Journal of Clinical Psychopharmacology
- Published
- 2010-02
- Volume
- 30
- Issue
- 1
- Pages
- 18-24
- ISSN
- 0271-0749 (ISSN-L)
- OpenAlex
- W2011850312
- Cited by
- 33
- References
- 23
- Citations by year
- 2026: 2 · 2025: 3 · 2024: 2 · 2023: 1 · 2022: 1 · 2020: 3 · 2019: 1 · 2018: 1 · 2017: 1 · 2016: 3 · 2015: 4 · 2014: 1 · 2013: 5
- FWCI
- 2.35
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Psychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
- Keywords
- desvenlafaxine, major depressive disorder, relapse prevention, antidepressant efficacy, adverse events, treatment discontinuation, serotonin-norepinephrine reuptake inhibitors
- MeSH terms
- Desvenlafaxine Succinate, Adult, Antidepressive Agents, Cyclohexanols, Major Depressive Disorder, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Psychiatric Status Rating Scales, Treatment Outcome, Secondary Prevention
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