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Levomilnacipran

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https://www.readbyqxmd.com/read/29677603/the-comparative-evidence-basis-for-the-efficacy-of-second-generation-antidepressants-in-the-treatment-of-depression-in-the-us-a-bayesian-meta-analysis-of-food-and-drug-administration-reviews
#1
Rei Monden, Annelieke M Roest, Don van Ravenzwaaij, Eric-Jan Wagenmakers, Richard Morey, Klaas J Wardenaar, Peter de Jonge
BACKGROUND: Studies have shown similar efficacy of different antidepressants in the treatment of depression. METHOD: Data of phase-2 and -3 clinical-trials for 16 antidepressants (levomilnacipran, desvenlafaxine, duloxetine, venlafaxine, paroxetine, escitalopram, vortioxetine, mirtazapine, venlafaxine XR, sertraline, fluoxetine, citalopram, paroxetine CR, nefazodone, bupropion, vilazodone), approved by the FDA for the treatment of depression between 1987 and 2016, were extracted from the FDA reviews that were used to evaluate efficacy prior to marketing approval, which are less liable to reporting biases...
April 6, 2018: Journal of Affective Disorders
https://www.readbyqxmd.com/read/29238196/the-role-of-new-antidepressants-in-clinical-practice-in-canada-a-brief-review-of-vortioxetine-levomilnacipran-er-and-vilazodone
#2
REVIEW
Roger S McIntyre
Although many branded and generic antidepressants are approved for the treatment of major depressive disorder (MDD) in Canada, efficacy and tolerability differ among patients, and new treatment options are needed. Symptom types (eg, fatigue, energy/motivation, cognition, and functioning), medication type, treatment duration, and the need for maintenance therapy are factors that may influence treatment effectiveness. Three antidepressants, vortioxetine, levomilnacipran extended-release (ER), and vilazodone have recently become available in Canada...
2017: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/29197738/efficacy-and-safety-of-levomilnacipran-vilazodone-and-vortioxetine-compared-with-other-second-generation-antidepressants-for-major-depressive-disorder-in-adults-a-systematic-review-and-network-meta-analysis
#3
REVIEW
Gernot Wagner, Marie-Therese Schultes, Viktoria Titscher, Birgit Teufer, Irma Klerings, Gerald Gartlehner
BACKGROUND: Second-generation antidepressants dominate the medical management of major depressive disorder (MDD). Levomilnacipran, vilazodone and vortioxetine are the latest therapeutic options approved for the treatment of MDD. This systematic review aims to compare the benefits and harms of vilazodone, levomilnacipran, and vortioxetine with one another and other second-generation antidepressants. METHODS: We searched electronic databases up to September 2017 and reviewed reference lists and pharmaceutical dossiers to detect published and unpublished studies...
March 1, 2018: Journal of Affective Disorders
https://www.readbyqxmd.com/read/29195487/efficacy-of-levomilnacipran-extended-release-in-treating-major-depressive-disorder
#4
Renee-Marie Ragguett, Samantha J Yim, Peter T Ho, Roger S McIntyre
Major depressive disorder (MDD) is the leading cause of disability worldwide with a heterogeneous symptom profile. Levomilnacipran extended release (ER) (Fetzima), a SNRI, has been approved by the Food and Drug Administration for treatment of MDD. While categorized as a SNRI, in contradistinction to other approved SNRIs, levomilnacipran exhibits differential affinity for the norepinephrine reuptake transporter when compared to the serotonin reuptake transporter. Areas covered: Completed clinical trials which focused on levomilnacipran ER administered in those with MDD were included in this drug evaluation...
December 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/29154157/efficacy-of-antidepressants-on-measures-of-workplace-functioning-in-major-depressive-disorder-a-systematic-review
#5
REVIEW
Yena Lee, Joshua D Rosenblat, JungGoo Lee, Nicole E Carmona, Mehala Subramaniapillai, Margarita Shekotikhina, Rodrigo B Mansur, Elisa Brietzke, Jae-Hon Lee, Roger C Ho, Samantha J Yim, Roger S McIntyre
INTRODUCTION: Work-related disability and productivity loss in Major Depressive Disorder (MDD) are critical determinants of patient quality of life and contribute significantly to the human and economic costs of MDD. Notwithstanding the return to work and pre-morbid levels of functioning as a critical therapeutic objective among individuals with MDD, it is unclear whether antidepressant treatment significantly and reliably improves measures of workplace functioning. Herein, we investigate to what extent antidepressant treatment improves workplace functioning among adults with MDD...
February 2018: Journal of Affective Disorders
https://www.readbyqxmd.com/read/29127931/efficacy-and-tolerability-of-different-doses-of-three-new-antidepressants-for-treating-major-depressive-disorder-a-prisma-compliant-meta-analysis
#6
Hairong He, Wei Wang, Jun Lyu, Jie Zheng, Liyang Guo, Xiaofang An, Yajuan Fan, Xiancang Ma
In last decade, the US FDA has approved three new antidepressants: vortioxetine, levomilnacipran, and vilazodone. Many studies have researched the effects of these antidepressants on major depressive disorder (MDD), but they have not determined the optimum dosage. This meta-analysis investigated the efficacies of these three drugs at different dosages in the treatment of MDD. The PubMed, Embase, Cochrane Library, psycINFO, and ClinicalTrials.gov databases were searched to identify relevant literature. The primary outcomes were efficacy [quantified as the change from baseline in total score on the Montgomery-Asberg Depression Rating Scale (MADRS)] and tolerability (discontinuations due to adverse events)...
January 2018: Journal of Psychiatric Research
https://www.readbyqxmd.com/read/28521846/measures-of-suicidality-in-phase-3-clinical-trials-of-levomilnacipran-er-in-adults-with-major-depressive-disorder
#7
Michael E Thase, Carl Gommoll, Changzheng Chen, Kenneth Kramer, Arif Khan, Suresh Durgam
OBJECTIVE: To evaluate the effects of levomilnacipran extended-release (ER) on suicidal ideation and behavior in adults with major depressive disorder (MDD). METHODS: Post hoc analyses were conducted in patients from 4 randomized, double-blind, placebo-controlled trials and a long-term, open-label extension study of levomilnacipran ER (40-120 mg/d) in adults with MDD. Analyses included incidence of suicide-related treatment-emergent adverse events (TEAEs); incidence of Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation (score=1-5) and behavior (score=6-10); percent of patients who shifted from no C-SSRS suicidal ideation/behavior at baseline to suicidal ideation during treatment (worsened from score=0 to score=1-5), or vice-versa (improved from score=1-5 to score=0)...
December 2017: CNS Spectrums
https://www.readbyqxmd.com/read/28317392/pharmacotherapy-of-major-depression-in-late-life-what-is-the-role-of-new-agents
#8
REVIEW
Kinjal Patel, Petal S Abdool, Tarek K Rajji, Benoit H Mulsant
Evidence on the pharmacotherapy of late-life major depressive disorder (LLD) is scant. Most of the recommendations in existing clinical guidelines are based on expert opinions, extrapolations from data obtained in younger patients, or theoretical considerations. Areas covered: This article summarizes the recommendations from existing clinical guidelines and recent reviews on the treatment of LLD. Next, it discusses the potential role of newer antidepressants - vilazodone, levomilnacipran, and vortioxetine - based on a systematic search of the literature published during the past five years...
April 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28068615/effects-of-levomilnacipran-er-on-noradrenergic-symptoms-anxiety-symptoms-and-functional-impairment-in-adults-with-major-depressive-disorder-post-hoc-analysis-of-5-clinical-trials
#9
Pierre Blier, Carl Gommoll, Changzheng Chen, Kenneth Kramer
OBJECTIVE: To evaluate the effects of levomilnacipran extended-release (LVM-ER; 40-120mg/day) on noradrenergic (NA) and anxiety-related symptoms in adults with major depressive disorder (MDD) and explore the relationship between these symptoms and functional impairment. METHODS: Data were pooled from 5 randomized, double-blind, placebo-controlled trials (N=2598). Anxiety and NA Cluster scores were developed by adding selected item scores from the Montgomery-Åsberg Depression Rating Scale (MADRS) and 17-item Hamilton Depression Rating Scale (HAMD17 )...
March 1, 2017: Journal of Affective Disorders
https://www.readbyqxmd.com/read/27861191/effects-of-levomilnacipran-extended-release-on-major-depressive-disorder-patients-with-cognitive-impairments-post-hoc-analysis-of-a-phase-iii-study
#10
RANDOMIZED CONTROLLED TRIAL
Keith A Wesnes, Carl Gommoll, Changzheng Chen, Angelo Sambunaris, Roger S McIntyre, Philip D Harvey
Performance-based cognitive data were collected using the Cognitive Drug Research System in a study of levomilnacipran extended-release (ER) 40-120 mg/day (NCT01034462) in adults with major depressive disorder. These data were analyzed post-hoc to explore the relationship between cognitive measures, depression symptoms (Montgomery-Åsberg Depression Rating Scale, MADRS), and self-reported psychosocial functioning (Sheehan Disability Scale; SDS). Changes from baseline were analyzed in the intent-to-treat population and subgroups with impaired attention, as indicated by baseline Cognitive Drug Research System scores for Power of Attention and Continuity of Attention...
March 2017: International Clinical Psychopharmacology
https://www.readbyqxmd.com/read/27822042/efficacy-and-safety-of-multiple-doses-of-levomilnacipran-extended-release-for-the-treatment-of-major-depressive-disorder
#11
Qunlian Huang, Xiaoyan Zhong, Ye Yun, Bin Yu, Yilan Huang
OBJECTIVE: The aim of this meta-analysis was to evaluate the efficacy and safety of levomilnacipran extended-release (ER) in the treatment of major depressive disorder (MDD). METHODS: Randomized controlled trials were searched by electronic databases. Unpublished data were also searched by the relevant websites. Weighted mean difference (WMD) and risk ratio (RR) with 95% confidence interval (CI) were calculated and pooled using fixed-effects model or random-effects model...
2016: Neuropsychiatric Disease and Treatment
https://www.readbyqxmd.com/read/27508501/the-safety-tolerability-and-risks-associated-with-the-use-of-newer-generation-antidepressant-drugs-a-critical-review-of-the-literature
#12
REVIEW
André F Carvalho, Manu S Sharma, André R Brunoni, Eduard Vieta, Giovanni A Fava
Newer generation antidepressant drugs (ADs) are widely used as the first line of treatment for major depressive disorders and are considered to be safer than tricyclic agents. In this critical review, we evaluated the literature on adverse events, tolerability and safety of selective serotonin reuptake inhibitors, serotonin noradrenaline reuptake inhibitors, bupropion, mirtazapine, trazodone, agomelatine, vilazodone, levomilnacipran and vortioxetine. Several side effects are transient and may disappear after a few weeks following treatment initiation, but potentially serious adverse events may persist or ensue later...
2016: Psychotherapy and Psychosomatics
https://www.readbyqxmd.com/read/27455513/effects-of-levomilnacipran-extended-release-on-motivation-energy-and-functioning-in-adults-with-major-depressive-disorder
#13
RANDOMIZED CONTROLLED TRIAL
Michael E Thase, Carl Gommoll, Changzheng Chen, Kenneth Kramer, Angelo Sambunaris
The objective of this post-hoc analysis was to investigate the relationship between motivation/energy and functional impairment in patients with major depressive disorder (MDD). Data were taken from a phase 3 trial of levomilnacipran extended-release (ER) in adults with MDD (NCT01034462; N=429) that used the 18-item Motivation and Energy Inventory (MEI) to assess motivation/energy. Two subgroups with lower and higher motivation/energy were defined using baseline MEI total scores (≤28 and >28, respectively)...
November 2016: International Clinical Psychopharmacology
https://www.readbyqxmd.com/read/27401359/comparative-efficacy-and-acceptability-of-first-generation-and-second-generation-antidepressants-in-the-acute-treatment-of-major-depression-protocol-for-a-network-meta-analysis
#14
COMPARATIVE STUDY
Toshi A Furukawa, Georgia Salanti, Lauren Z Atkinson, Stefan Leucht, Henricus G Ruhe, Erick H Turner, Anna Chaimani, Yusuke Ogawa, Nozomi Takeshima, Yu Hayasaka, Hissei Imai, Kiyomi Shinohara, Aya Suganuma, Norio Watanabe, Sarah Stockton, John R Geddes, Andrea Cipriani
INTRODUCTION: Many antidepressants are indicated for the treatment of major depression. Two network meta-analyses have provided the most comprehensive assessments to date, accounting for both direct and indirect comparisons; however, these reported conflicting interpretation of results. Here, we present a protocol for a systematic review and network meta-analysis aimed at updating the evidence base and comparing all second-generation as well as selected first-generation antidepressants in terms of efficacy and acceptability in the acute treatment of major depression...
July 8, 2016: BMJ Open
https://www.readbyqxmd.com/read/27292817/the-efficacy-of-levomilnacipran-er-across-symptoms-of-major-depressive-disorder-a-post-hoc-analysis-of-5-randomized-double-blind-placebo-controlled-trials
#15
Roger S McIntyre, Carl Gommoll, Changzheng Chen, Adam Ruth
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)...
October 2016: CNS Spectrums
https://www.readbyqxmd.com/read/27180420/levomilnacipran-a-successor-of-milnacipran-with-a-higher-noradrenergic-selectivity
#16
REVIEW
Łukasz Zadka, Ewelina Dziwota, Marcin Olajossy
A new antidepressant, levomilnacipran, is the levorotatory enantiomer of milnacipran. The drug belongs to selective serotonin-norepinephrine reuptake inhibitors (SNRI) and has the highest noradrenergic selectivity of all members of this group of antidepressants. Clinical trials have confirmed the effectiveness of levomilnacipran in the treatment of depression. The drug was placed on the US market in the form of prolonged-release capsules, which greatly simplifies the treatment of psychiatric patients. The safety of the drug is also higher than the safety of a racemate, resulting in a beneficial impact on the therapeutic effect...
March 2016: Acta Poloniae Pharmaceutica
https://www.readbyqxmd.com/read/27141705/levomilnacipran-and-vortioxetine-for-adults-with-major-depressive-disorder
#17
REVIEW
Jonathan R Scarff
No abstract text is available yet for this article.
December 2015: Journal of the South Carolina Medical Association
https://www.readbyqxmd.com/read/26967743/a-review-of-antidepressant-induced-urinary-hesitancy-a-focus-on-levomilnacipran-er-including-two-case-presentations-5633
#18
REVIEW
Gregory M Asnis, Elishka Caneva, Margaret A Henderson
INTRODUCTION: Levomilnacipran ER was recently FDA approved as Fetzima® for the treatment of MDD. Urinary hesitancy can be an adverse event associated with levomilnacipran treatment. AREAS COVERED: This manuscript details the longitudinal course of levomilnacipran-induced urinary hesitancy in 2 cases that were in a pivotal clinical trial, examining possible predisposing factors and treatment issues. This manuscript also reviews the literature comparing urinary hesitancy associated with levomilnacipran versus other antidepressants...
May 2016: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/26938965/vortioxetine-for-major-depressive-disorder-an-indirect-comparison-with-duloxetine-escitalopram-levomilnacipran-sertraline-venlafaxine-and-vilazodone-using-number-needed-to-treat-number-needed-to-harm-and-likelihood-to-be-helped-or-harmed
#19
REVIEW
Leslie Citrome
BACKGROUND: Vortioxetine is approved for the treatment of major depressive disorder and differs from other antidepressants in terms of its pharmacodynamic profile. Given the limited number of head-to-head studies comparing vortioxetine with other antidepressants, indirect comparisons using effect sizes observed in other trials can be helpful to discern potential differences in clinical outcomes. METHODS: Data sources were the clinical trial reports for the pivotal short-term double-blind trials for vortioxetine and from publicly available sources for the pivotal short-term double-blind trials for two commonly used generic serotonin specific reuptake inhibitor antidepressants (sertraline, escitalopram), two commonly used generic serotonin-norepinephrine reuptake inhibitor antidepressants (venlafaxine, duloxetine), and two recently introduced branded antidepressants (vilazodone, levomilnacipran)...
May 15, 2016: Journal of Affective Disorders
https://www.readbyqxmd.com/read/26773906/the-effects-of-levomilnacipran-er-in-adult-patients-with-first-episode-highly-recurrent-or-chronic-mdd
#20
RANDOMIZED CONTROLLED TRIAL
Susan G Kornstein, Carl Gommoll, Changzheng Chen, Kenneth Kramer
BACKGROUND: Major depressive disorder (MDD) can be challenging to manage due its variable and episodic nature. Post hoc analyses were conducted on five studies (NCT00969709, NCT01377194, NCT00969150, NCT01034462, EudraCT:2006-002404-34) to evaluate the efficacy of levomilnacipran extended-release (ER) in patients with different MDD episode histories. METHODS: Adults with MDD were randomized to double-blind treatment with levomilnacipran ER (40-120mg/d) or placebo...
March 15, 2016: Journal of Affective Disorders
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