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Milnacipran efficacy in the prevention of recurrent depression: a 12-month placebo-controlled study
Abstract
To compare the efficacy and assess the tolerability of milnacipran 50mg p.o. b.i.d. to placebo in the prevention of recurrence in depressed patients who had responded an acute treatment and had remained in remission during a 4-month continuation phase. Remission criteria were: a Hamilton Depression Rating Scale (HDRS) (21-item) < or = 8, improvement or disappearance of the initial symptoms, and an assessment of 'very much improved' or 'much improved' on the Clinical Global Impression (CGI) Subscale: Global Improvement. Recurrence was defined by a major depressive episode according to DSM-III-R criteria and a minimum score of 18 on the HDRS, with the need to treat the recurrence. The primary analysis was the rate of recurrence as a function of time in the intent-to-treat population. Groups were compared using the Cox model. Absolute recurrence rates were 16.3% (17/104) in milnacipran-treated patients and 23.6% (26/110) in placebo-treated patients, with a significant difference in the reduction of recurrence as a function of time (Kaplan Meier Survival Analysis analysis, P < 0.05). There was no difference in tolerability between groups. This study demonstrates that milnacipran is effective with good tolerability in preventing recurrence in major depressive disorder over 1 year in patients with recurrent depression who responded to acute treatment with milnacipran and continued their response for 18 weeks.
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One double-blind randomized placebo-controlled trial reported that levomilnacipran outperformed placebo in relapse rate at study-endpoint, while another did not report the statistical result; one trial investigating milnacipran also did not report statistical results.
“One DBRPCT reported that levomilnacipran outperformed placebo in terms of relapse rate at the study-endpoint [22], while another DBRPCT did not report the statistical result of the outcome [49]; one trial investigating milnacipran also did not report the statistical results [47].”
From Antidepressants for the treatment of adults with major depressive disorder in the maintenance phase: a systematic review and network meta-analysis (2023) · cites this paper as [47]
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Sim, K., Lau, W. K., Sim, J., Sum, M. Y., & Baldessarini, R. J. (2016) · International Journal of Neuropsychopharmacology · doi:10.1093/ijnp/pyv076 · Cited by 218
“All but five trials (Maj et al., 1992; Rouillon et al., 2000; Wilson et al., 2003; Reynolds et al., 2006; Kasper et al., 2008) yielded statistically superior benefits of active agents over placebo treatments in reducing recurrence risk.”
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“One DBRPCT reported that levomilnacipran outperformed placebo in terms of relapse rate at the study-endpoint [22], while another DBRPCT did not report the statistical result of the outcome [49]; one trial investigating milnacipran also did not report the statistical results [47].”
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Metadata
- Authors
- Rouillon, F., Warner, B., Pezous, N., & Bisserbe, J. C.
- Affiliations
- Hôpital Albert-Chenevier (FR)
- Corresponding author
- Rouillon, F.
- Venue
- International Clinical Psychopharmacology
- Published
- 2000-05
- Volume
- 15
- Issue
- 3
- Pages
- 133-140
- ISSN
- 0268-1315 (ISSN-L)
- OpenAlex
- W2023452650
- Cited by
- 47
- References
- 0
- Citations by year
- 2026: 1 · 2025: 2 · 2023: 1 · 2022: 3 · 2021: 1 · 2020: 2 · 2019: 1 · 2018: 1 · 2016: 1 · 2015: 2 · 2013: 1
- FWCI
- 1.76
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- International Clinical Psychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
- Keywords
- milnacipran, recurrent depression, depression recurrence prevention, major depressive disorder, continuation phase, remission, antidepressant efficacy, drug tolerability, selective serotonin reuptake inhibitors
- MeSH terms
- Milnacipran, Adult, Antidepressive Agents, Cyclopropanes, Depressive Disorder, Female, Humans, Male, Middle Aged, Recurrence, Treatment Outcome, Disease Progression
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