Trial reportClinical drug investigation2013
Safety and tolerability of levomilnacipran ER in major depressive disorder: results from an open-label, 48-week extension study.
Trial report in Clinical drug investigation, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 13 papers.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed, 194 citations in OpenAlex.
- Relapse prevention with levomilnacipran ER in adults with major depressive disorder: A multicenter, randomized, double-blind, placebo-controlled study.Depression and anxiety · 2019Trial
- Evaluation of Cytochrome P450 (CYP) 3A4-Based Interactions of Levomilnacipran with Ketoconazole, Carbamazepine or Alprazolam in Healthy Subjects.Clinical drug investigation · 2015Trial
- Disposition and metabolism of [14C]-levomilnacipran, a serotonin and norepinephrine reuptake inhibitor, in humans, monkeys, and rats.Drug design, development and therapy · 2015Trial
- Disproportionality analysis of safety signals for milnacipran and levomilnacipran: a pharmacovigilance study using the FDA adverse event reporting system.Frontiers in pharmacology · 2025Article
- Antidepressant Drugs Effects on Blood Pressure.Frontiers in cardiovascular medicine · 2021Review
- Prediction of Suicide-Related Events by Analyzing Electronic Medical Records from PTSD Patients with Bipolar Disorder.Brain sciences · 2020Article
- The role of new antidepressants in clinical practice in Canada: a brief review of vortioxetine, levomilnacipran ER, and vilazodone.Neuropsychiatric disease and treatment · 2017Review
- Efficacy and safety of multiple doses of levomilnacipran extended-release for the treatment of major depressive disorder.Neuropsychiatric disease and treatment · 2016Article
- The Role of Levomilnacipran in the Management of Major Depressive Disorder: A Comprehensive Review.Current neuropharmacology · 2016Review
- A review of significant pharmacokinetic drug interactions with antidepressants and their management.The mental health clinician · 2016Review
- 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
- 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.Innovations in clinical neuroscience · 2014Article
Corrections and comments
- Erratum issued
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLevomilnacipran (1S, 2R-milnacipran) is a potent and selective serotonin (5-HT) and norepinephrine (noradrenaline) reuptake inhibitor approved for the treatment of major depressive disorder in adults.
objectiveThe objective of this study was to evaluate the longer-term safety and tolerability of levomilnacipran extended-release (ER).
methodsPatients who completed double-blind treatment/down-taper in one of three lead-in levomilnacipran ER studies were eligible for this 48-week open-label extension. Safety evaluations included assessment of treatment-emergent adverse events (TEAEs), physical examinations, laboratory and vital sign measures, and suicidality, summarized using descriptive statistics for the safety population.
resultsThe completion rate was 47 %; median treatment duration was 280 days. The most frequent reasons for discontinuation were withdrawal of consent (14 %) and adverse events (AEs; 13 %). TEAEs were reported by 712 (86 %) patients; most were mild/moderate and occurred early in treatment. The most common TEAEs were headache (22 %) and nausea (16 %); 36 (4 %) patients had ≥1 serious AEs. No clinically meaningful changes occurred in mean liver enzyme, metabolic, hematologic, urinalysis, or serum values; potentially clinically significant high AST or ALT values (≥3 × upper limit of normal) occurred in five patients. Vital sign changes occurred early and remained relatively stable. Mean increases for pulse rate (9.1 beats per minute [bpm]), and supine systolic (3.9 mmHg) and diastolic (3.3 mmHg) blood pressure were noted. The increase in the mean QT interval corrected using the Bazett formula (10.9 ms) was consistent with heart rate increase (12.8 bpm); there was no meaningful change in mean QT interval corrected using the Fridericia formula (-1.3 ms). Other than tachycardia and heart rate increases, ECG-related TEAEs were low (<0.5 %).
conclusionNo new or inconsistent safety/tolerability findings were discovered during longer-term evaluation.
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