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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
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)...
November 15, 2016: Journal of Affective Disorders
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
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
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
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
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
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)...
June 13, 2016: CNS Spectrums
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
Jonathan R Scarff
No abstract text is available yet for this article.
December 2015: Journal of the South Carolina Medical Association
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
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
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
Christoffer Bundgaard, Elin Eneberg, Connie Sánchez
P-glycoprotein (P-gp)-mediated brain efflux of xenobiotics is a well-known process, which may result in suboptimal target engagement and consequently reduced efficacy of drugs exerting their therapeutic effects in the central nervous system. In the present study the role of P-gp in transport across the blood-brain barrier (BBB) was investigated with a series of newer antidepressants (levomilnacipran, vilazodone and vortioxetine) and a control substrate (escitalopram) using P-gp knock-out (KO) and P-gp competent wild-type (WT) mice...
April 2016: Neuropharmacology
Andrew J Cutler, Carl P Gommoll, Changzheng Chen, William M Greenberg, Adam Ruth
OBJECTIVE: In this post hoc analysis, improvement in functional impairment in patients with major depressive disorder (MDD) treated with levomilnacipran extended release (ER) was evaluated by assessing shifts from more severe to less severe functional impairment categories on individual Sheehan Disability Scale (SDS) subscales. METHOD: SDS data were pooled from 5 phase II/III studies conducted between December 2006 and March 2012 of levomilnacipran ER versus placebo in adult patients with MDD (DSM-IV-TR criteria)...
2015: Primary Care Companion to CNS Disorders
Marlene P Freeman, Maurizio Fava, Carl Gommoll, Changzheng Chen, William M Greenberg, Adam Ruth
The aim of this study was to evaluate the effects of levomilnacipran extended-release (ER) on depression-related fatigue in adults with major depressive disorder. Post-hoc analyses of five phase III trials were carried out, with evaluation of fatigue symptoms based on score changes in four items: Montgomery-Åsberg Depression Rating Scale (MADRS) item 7 (lassitude), and 17-item Hamilton Depression Rating Scale (HAMD17) items 7 (work/activities), 8 (retardation), and 13 (somatic symptoms). Symptom remission was analyzed on the basis of score shifts from baseline to end of treatment: MADRS item 7 and HAMD17 item 7 (from ≥2 to ≤1); HAMD17 items 8 and 13 (from ≥1 to 0)...
March 2016: International Clinical Psychopharmacology
Antonio Bruno, Paolo Morabito, Edoardo Spina, Maria Rosaria Muscatello
Levomilnacipran, the more active enantiomer of the serotonin and norepinephrine reuptake inhibitor (SNRI) milnacipran, was recently approved in the US for the treatment of major depressive disorder (MDD). The drug was developed as an extended release (ER) capsule formulation to allow for once-daily administration, thereby improving patient adherence. This agent differs from other available SNRIs in having a greater potency for inhibition of norepinephrine relative to serotonin reuptake. The efficacy of levomilnacipran ER has been evaluated in seven randomised, double-blind clinical trials (one Phase II and four Phase III trials, and two long-term efficacy studies)...
2016: Current Neuropharmacology
Samira Zaman, Maura R McLaughlin
No abstract text is available yet for this article.
October 15, 2015: American Family Physician
Mark Zimmerman, Heather L Clark, Matthew D Multach, Emily Walsh, Lia K Rosenstein, Douglas Gazarian
BACKGROUND: We recently conducted a comprehensive review of the psychiatric inclusion/exclusion criteria used in 170 placebo-controlled antidepressant efficacy trials (AETs) published during the past 20 years and found that the criteria of more recent studies were significantly more restrictive than prior studies. Vortioxetine is the most recently approved medication for the treatment of major depressive disorder (MDD). We compared the inclusion/exclusion criteria of the vortioxetine studies to the criteria used in other AETs, and discuss the broader issue of the generalizability of AETs and the implications this might have for the labeling of antidepressants receiving FDA approval...
January 15, 2016: Journal of Affective Disorders
Stephan Köhler, Katharina Cierpinsky, Golo Kronenberg, Mazda Adli
The monoamine hypothesis of depression posits that an imbalance in monoaminergic neurotransmission is causally related to the clinical features of depression. Antidepressants influencing serotonin mainly aim at raising serotonin concentrations, thereby increasing serotonergic transmission at the level of the synapse, for example by inhibiting the serotonin transporter. However, the serotonin system is multifaceted. Different serotonin receptor subtypes turn the serotonergic system into a complex neurochemical arrangement that influences diverse neurotransmitters in various brain regions...
January 2016: Journal of Psychopharmacology
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