ArticleInnovations in clinical neuroscience2014
A Randomized, Double-blind, Placebo-controlled Trial of the Efficacy and Safety of Levomilnacipran ER 40-120mg/day for Prevention of Relapse in Patients with Major Depressive Disorder.
Article in Innovations in clinical neuroscience, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01085812 (A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder), which is not on this map. Cited by 13 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter, Randomized, Double-blind, Placebo-Controlled, Relapse-Prevention Study With F2695 SR in Patients With Major Depressive Disorder
Who cites it
13 citing papers in PubMed, 3 syntheses or guidelines pooled it, 24 citations in OpenAlex.
- Antidepressants for the treatment of adults with major depressive disorder in the maintenance phase: a systematic review and network meta-analysis.Molecular psychiatry · 2023Pooled it
- Discontinuation of antidepressants after remission with antidepressant medication in major depressive disorder: a systematic review and meta-analysis.Molecular psychiatry · 2021Pooled it
- Canadian Network for Mood and Anxiety Treatments (CANMAT) 2016 Clinical Guidelines for the Management of Adults with Major Depressive Disorder: Section 3. Pharmacological Treatments.Canadian journal of psychiatry. Revue canadienne de psychiatrie · 2016Pooled it
- Relapse prevention with levomilnacipran ER in adults with major depressive disorder: A multicenter, randomized, double-blind, placebo-controlled study.Depression and anxiety · 2019Trial
- Effect of renal impairment on the pharmacokinetics of levomilnacipran following a single oral dose of levomilnacipran extended-release capsule in humans.Drug design, development and therapy · 2015Trial
- Disposition and metabolism of [14C]-levomilnacipran, a serotonin and norepinephrine reuptake inhibitor, in humans, monkeys, and rats.Drug design, development and therapy · 2015Trial
- Testing the internal validity of the maintenance/discontinuation study design for antidepressant medications in depression using simulations.medRxiv : the preprint server for health sciences · 2025Article
- Disproportionality analysis of safety signals for milnacipran and levomilnacipran: a pharmacovigilance study using the FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
- The Role of Levomilnacipran in the Management of Major Depressive Disorder: A Comprehensive Review.Current neuropharmacology · 2016Review
- Efficacy and safety of multiple doses of levomilnacipran extended-release for the treatment of major depressive disorder.Neuropsychiatric disease and treatment · 2016Article
- Levomilnacipran Extended-Release Treatment in Patients With Major Depressive Disorder: Improvements in Functional Impairment Categories.The primary care companion for CNS disorders · 2015Article
- Levomilnacipran for the treatment of major depressive disorder: a review.Neuropsychiatric disease and treatment · 2015Review
- Levomilnacipran extended-release: a review of its use in adult patients with major depressive disorder.CNS drugs · 2014Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveMajor depressive disorder is often chronic, with relapse and recurrence common. Levomilnacipran extended-release is a potent and selective serotonin and reuptake inhibitor approved in the United States for treatment of major depressive disorder in adults. The objective of this study (NCT01085812) was to evaluate the efficacy, safety, and tolerability of levomilnacipran extended-release in the prevention of relapse in patients with major depressive disorder.
designA 24-week Phase III randomized, double-blind, controlled trial comparing levomilnacipran extended-release 40-120mg/day with placebo for relapse prevention in patients with major depressive disorder who had responded to 12-week, open-label treatment with levomilnacipran extended-release. Statistical power was calculated on the assumption that 38 percent of placebo and 20 percent of levomilnacipran extended-release patients would relapse.
settingThirty-six outpatient study centers throughout the United States and Canada.
participantsOf 348 patients who met randomization criteria and entered double-blind treatment, three discontinued prior to treatment, 112 were randomized to placebo, and 233 to levomilnacipran extended-release. MEASUREMENTS: PRIMARY OUTCOME: Time to relapse was analyzed using the Cox proportional hazard-regression model with treatment group and baseline Montgomery-Åsberg Depression Rating Scale score as explanatory variables. Safety was also evaluated.
resultsTime to relapse was longer for levomilnacipran extended-release versus placebo (hazard ratio [95% confidence interval] = 0.68 [0.40][1.17]), but the treatment difference was not statistically significant (P=0.165). A relatively low percentage of patients from either group relapsed (placebo=20.5%, levomilnacipran extended-release=13.9%).
conclusionThis study did not detect between-treatment group differences, potentially due to lower than expected relapse rates in the placebo group. Levomilnacipran extended-release was generally well tolerated.
Indexed as
Identifiers
24653937PMC3960779W296622129What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.