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[PMID]:28594246
[Au] Autor:Heise CW; Malashock H; Brooks DE
[Ad] Endereço:a Center for Toxicology & Pharmacology Education and Research , College of Medicine - Phoenix, University of Arizona , Phoenix , AZ , USA.
[Ti] Título:A review of vilazodone exposures with focus on serotonin syndrome effects.
[So] Source:Clin Toxicol (Phila);55(9):1004-1007, 2017 Nov.
[Is] ISSN:1556-9519
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Vilazodone is an antidepressant with selective serotonin reuptake inhibition and partial 5HT1A agonism. Serotonin syndrome is believed to be due to excessive stimulation of 5-HT2A and 5-HT1A receptors, resulting in the clinical triad of altered mentation, autonomic instability and neuromuscular abnormalities. The goal of this study is to define serotonergic effects after vilazodone exposure. METHODS: A retrospective review of two databases: the American Association of Poison Controls Centers' National Poison Data System (NPDS) and the American College of Medical Toxicology's Toxicology Investigators Consortium (ToxIC Registry). A case series of four patients from one medical toxicology service is also presented. RESULTS: During the 52-month study period, a total of 3192 vilazodone human exposures were reported to NPDS. Of these, 1734 (54%) were isolated vilazodone cases. The clinical effects of vilazodone toxicity included drowsiness (20%), vomiting (14%), tachycardia (11%) and agitation (10%). Most patients (71%) had symptoms for between 2 and 24 h, though some (14%) remained symptomatic for more than 24 h. The most common treatment was intravenous fluids (15%) and the most serious intubation (2%). From the ToxIC Registry, a total of 23 cases of vilazodone exposures were identified. Of these, 17 (74%) had vilazodone listed as the first (primary) agent and 10 (43%) involved vilazodone-only ingestions. Nine (39%) cases documented serotonin syndrome; and most (8/9; 89%) listed vilazodone as the primary agent. All (n = 4) subjects in the case series with acute vilazodone toxicity had serotonin syndrome. CONCLUSIONS: Vilazodone overdose, including vilazodone-only ingestions, are associated with serotonin syndrome. Serotonergic toxicity and appropriate treatments should be considered when caring for patients with vilazodone ingestions.
[Mh] Termos MeSH primário: Antidepressivos/envenenamento
Agonistas de Receptores 5-HT1 de Serotonina/envenenamento
Síndrome da Serotonina/induzido quimicamente
Inibidores da Captação de Serotonina/envenenamento
Cloridrato de Vilazodona/envenenamento
[Mh] Termos MeSH secundário: Acidentes Domésticos
Adolescente
Adulto
Criança
Pré-Escolar
Bases de Dados Factuais
Overdose de Drogas
Agonismo Parcial de Drogas
Feminino
Hidratação
Seres Humanos
Masculino
Centros de Controle de Intoxicações
Estudos Retrospectivos
Síndrome da Serotonina/sangue
Síndrome da Serotonina/diagnóstico
Tentativa de Suicídio
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:CASE REPORTS; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antidepressive Agents); 0 (Serotonin 5-HT1 Receptor Agonists); 0 (Serotonin Uptake Inhibitors); U8HTX2GK8J (Vilazodone Hydrochloride)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170911
[Lr] Data última revisão:
170911
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170609
[St] Status:MEDLINE
[do] DOI:10.1080/15563650.2017.1332369


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[PMID]:28421837
[Au] Autor:Russell JL; Spiller HA; Chounthirath T; Casavant MJ
[Ad] Endereço:a Nationwide Children's Hospital , Columbus , OH , USA.
[Ti] Título:Pediatric ingestion of vilazodone compared to other selective serotonin reuptake inhibitor medications.
[So] Source:Clin Toxicol (Phila);55(5):352-356, 2017 Jun.
[Is] ISSN:1556-9519
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Unintentional ingestion of selective serotonin reuptake inhibitor (SSRI) medications is common amongst children <6 years of age. Current evidence-based management guidelines are based on a low incidence of significant medical outcomes in these children. OBJECTIVE: To describe and compare outcomes of pediatric exposures to vilazodone with other SSRIs. METHODS: A retrospective observational case series analysis of both single and polysubstance SSRI exposures amongst children <6 years old reported to the National Poison Data System (NPDS). RESULTS: 11,384 SSRI exposures in children <6 years of age reported to NPDS between January 2012 and June 2016 were assessed. Vilazodone only accounted for 5.9% of all exposures, but resulted in the highest proportion of health care facility admission compared to other SSRIs, both in single substance (165 of 531 (31.1%); OR 9.0 [7.3-11.2]) and polysubstance (57 of 107 (53.3%); OR 4.1 [2.7-6.2]) exposures. Children exposed to vilazodone also have higher odds of experiencing a major or moderate outcome in single (134 of 531 (25.2%); OR 20.5 [15.5-27.1]) and polysubstance (37 of 107 (35.6%); OR 5.9 [3.7-9.0]) exposures compared to other SSRIs. Several severe clinical outcomes, such as seizure and coma, were more common among the vilazodone exposures. CONCLUSIONS: Exposure to vilazodone in this age group results in an increased rate of hospitalization as well as more severe clinical effects as compared to other SSRIs. Current evidence-based SSRI exposure management guidelines may not be appropriate for the management of vilazodone ingestion in this age group.
[Mh] Termos MeSH primário: Inibidores da Captação de Serotonina/envenenamento
Cloridrato de Vilazodona/envenenamento
[Mh] Termos MeSH secundário: Criança
Pré-Escolar
Citalopram/envenenamento
Coma/induzido quimicamente
Coma/tratamento farmacológico
Relação Dose-Resposta a Droga
Medicina Baseada em Evidências
Feminino
Fluoxetina/envenenamento
Fluvoxamina/envenenamento
Seguimentos
Hospitalização
Seres Humanos
Lactente
Masculino
Paroxetina/envenenamento
Centros de Controle de Intoxicações
Estudos Retrospectivos
Convulsões/induzido quimicamente
Convulsões/tratamento farmacológico
Resultado do Tratamento
[Pt] Tipo de publicação:COMPARATIVE STUDY; JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Nm] Nome de substância:
0 (Serotonin Uptake Inhibitors); 01K63SUP8D (Fluoxetine); 0DHU5B8D6V (Citalopram); 41VRH5220H (Paroxetine); O4L1XPO44W (Fluvoxamine); U8HTX2GK8J (Vilazodone Hydrochloride)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170425
[Lr] Data última revisão:
170425
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170420
[St] Status:MEDLINE
[do] DOI:10.1080/15563650.2017.1287375


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[PMID]:28317392
[Au] Autor:Patel K; Abdool PS; Rajji TK; Mulsant BH
[Ad] Endereço:a Centre for Addiction and Mental Health , Toronto , ON , Canada.
[Ti] Título:Pharmacotherapy of major depression in late life: what is the role of new agents?
[So] Source:Expert Opin Pharmacother;18(6):599-609, 2017 Apr.
[Is] ISSN:1744-7666
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: 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. Then, it presents evidence pertaining to the use of ketamine, aripiprazole, brexpiprazole, quetiapine, and methylphenidate in the treatment of LLD. Expert opinion: Very few recent publications directly relevant to the pharmacotherapy of LLD were identified: there are no published data supporting the use of vilazodone, levomilnacipran, ketamine, or brexpiprazole in older patients. Recent placebo-controlled randomized controlled trials (RCTs) support the use of vortioxetine, quetiapine monotherapy, aripiprazole augmentation, or methylphenidate augmentation (with one RCT for each). Thus, overall, there have been few innovations in the pharmacotherapy of LLD over the past decade and the stepwise approach recommended in older guidelines remains relevant today. More studies addressing the relative efficacy, tolerability, and safety of psychotropic medications are needed.
[Mh] Termos MeSH primário: Antidepressivos/uso terapêutico
Transtorno Depressivo Maior/tratamento farmacológico
[Mh] Termos MeSH secundário: Ciclopropanos/uso terapêutico
Seres Humanos
Piperazinas/uso terapêutico
Ensaios Clínicos Controlados Aleatórios como Assunto
Sulfetos/uso terapêutico
Cloridrato de Vilazodona/uso terapêutico
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Antidepressive Agents); 0 (Cyclopropanes); 0 (Piperazines); 0 (Sulfides); 3O2K1S3WQV (vortioxetine); G56VK1HF36 (milnacipran); U8HTX2GK8J (Vilazodone Hydrochloride)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170417
[Lr] Data última revisão:
170417
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170321
[St] Status:MEDLINE
[do] DOI:10.1080/14656566.2017.1308484


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[PMID]:27932864
[Au] Autor:Shi L; Wang J; Xu S; Lu Y
[Ad] Endereço:Department of Psychiatry, The Fourth Affiliated Hospital of Zhejiang University School of Medicine, Yiwu; Department of Neurosurgery, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, People's Republic of China.
[Ti] Título:Efficacy and tolerability of vilazodone for major depressive disorder: evidence from phase III/IV randomized controlled trials.
[So] Source:Drug Des Devel Ther;10:3899-3907, 2016.
[Is] ISSN:1177-8881
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:Vilazodone is a new molecule approved for major depressive disorder (MDD). This report focuses on the efficacy and tolerability of vilazodone for MDD. MEDLINE, EMBASE, and Cochrane Library were searched. A total of 1,930 patients from four trials were included. A significant improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) total score was seen as early as week 2 ( <0.01) in vilazodone-treated patients. The results showed a higher rate of MADRS response with vilazodone compared with placebo ( <0.001). There were also greater improvements in the Hamilton Rating Scale for Anxiety as well as the Clinical Global Impressions (severity of illness and improvement of illness) scores from baseline in vilazodone-treated patients compared to placebo patients ( <0.001). Discontinuation rates due to adverse events were higher with vilazodone than placebo ( =0.0002). The most common adverse events of vilazodone were vomiting, nausea, diarrhea, insomnia, somnolence, dizziness, and dry mouth ( <0.05). Treatment-related effects on sexual function were mild compared to placebo in men ( =0.03). In conclusion, 40 mg/day of vilazodone had a rapid onset of response and showed good improvement in anxiety symptoms as well as good tolerability during short-term treatment (8-10 weeks) for MDD. Further studies should focus on the efficacy and tolerability of vilazodone over a longer duration and should utilize active comparators.
[Mh] Termos MeSH primário: Transtorno Depressivo Maior/tratamento farmacológico
Cloridrato de Vilazodona/uso terapêutico
[Mh] Termos MeSH secundário: Ensaios Clínicos Fase III como Assunto
Ensaios Clínicos Fase IV como Assunto
Método Duplo-Cego
Tolerância a Medicamentos
Seres Humanos
Ensaios Clínicos Controlados Aleatórios como Assunto
Cloridrato de Vilazodona/administração & dosagem
Cloridrato de Vilazodona/efeitos adversos
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS
[Nm] Nome de substância:
U8HTX2GK8J (Vilazodone Hydrochloride)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170321
[Lr] Data última revisão:
170321
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161210
[St] Status:MEDLINE


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Registro de Ensaios Clínicos
Registro de Ensaios Clínicos
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[PMID]:27486544
[Au] Autor:Khan A; Durgam S; Tang X; Ruth A; Mathews M; Gommoll CP
[Ad] Endereço:Northwest Clinical Research Center, Bellevue, Washington; Duke University School of Medicine, Department of Psychiatry, Durham, North Carolina.
[Ti] Título:Post Hoc Analyses of Anxiety Measures in Adult Patients With Generalized Anxiety Disorder Treated With Vilazodone.
[So] Source:Prim Care Companion CNS Disord;18(2), 2016.
[Is] ISSN:2155-7780
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To investigate vilazodone, currently approved for major depressive disorder in adults, for generalized anxiety disorder (GAD). METHOD: Three randomized, double-blind, placebo-controlled studies showing positive results for vilazodone (2,040 mg/d) in adult patients with GAD (DSM-IV-TR) were pooled for analyses; data were collected from June 2012 to March 2014. Post hoc outcomes in the pooled intent-to-treat population (n = 1,462) included mean change from baseline to week 8 in Hamilton Anxiety Rating Scale (HARS) total score, psychic and somatic anxiety subscale scores, and individual item scores; HARS response (≥ 50% total score improvement) and remission (total score ≤ 7) at week 8; and category shifts, defined as HARS item score ≥ 2 at baseline (moderate to very severe symptoms) and score of 0 at week 8 (no symptoms). RESULTS: The least squares mean difference was statistically significant for vilazodone versus placebo in change from baseline to week 8 in HARS total score (-1.83, P < .0001) and in psychic anxiety (-1.21, P < .0001) and somatic anxiety (-0.63, P < .01) subscale scores; differences from placebo were significant on 11 of 14 HARS items (P < .05). Response rates were higher with vilazodone than placebo (48% vs 39%, P < .001), as were remission rates (27% vs 21%, P < .01). The percentage of patients who shifted to no symptoms was significant for vilazodone on several items: anxious mood, tension, intellectual, depressed mood, somatic-muscular, somatic-sensory, cardiovascular, respiratory, and autonomic symptoms (P < .05). CONCLUSIONS: Treatment with vilazodone versus placebo was effective in adult GAD patients, with significant differences between treatment groups found on both psychic and somatic HARS items. TRIAL REGISTRATION: ClinicalTrials.gov identifiers: NCT01629966, NCT01766401, NCT01844115.
[Mh] Termos MeSH primário: Ansiolíticos/uso terapêutico
Transtornos de Ansiedade/tratamento farmacológico
Cloridrato de Vilazodona/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Ansiedade/tratamento farmacológico
Transtornos de Ansiedade/psicologia
Método Duplo-Cego
Feminino
Seres Humanos
Análise dos Mínimos Quadrados
Masculino
Escalas de Graduação Psiquiátrica
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Anti-Anxiety Agents); U8HTX2GK8J (Vilazodone Hydrochloride)
[Em] Mês de entrada:1702
[Cu] Atualização por classe:170410
[Lr] Data última revisão:
170410
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160804
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.4088/PCC.15m01904


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[PMID]:27232052
[Au] Autor:Durgam S; Gommoll C; Forero G; Nunez R; Tang X; Mathews M; Sheehan DV
[Ad] Endereço:Forest Research Institute, Harborside Financial Center, Jersey City, NJ 07311. suresh.durgam@actavis.com.
[Ti] Título:Efficacy and Safety of Vilazodone in Patients With Generalized Anxiety Disorder: A Randomized, Double-Blind, Placebo-Controlled, Flexible-Dose Trial.
[So] Source:J Clin Psychiatry;77(12):1687-1694, 2016 Dec.
[Is] ISSN:1555-2101
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To evaluate the efficacy, safety, and tolerability of vilazodone as an acute treatment for generalized anxiety disorder (GAD). Vilazodone is a selective serotonin reuptake inhibitor and 5-HT1A receptor partial agonist approved for the treatment of major depressive disorder in adults. METHODS: This was a randomized, placebo-controlled, parallel-group, multicenter, flexible-dose study conducted from May 2013-March 2014. Adult patients (18-70 years, inclusive) who met DSM-IV-TR criteria for GAD were randomized (1:1) to placebo or vilazodone 20-40 mg/d for 8 weeks of double-blind treatment. Primary and secondary efficacy parameters were change from baseline to week 8 in the Hamilton Anxiety Rating Scale (HARS) total score and in the Sheehan Disability Scale (SDS) total score, respectively, analyzed using a mixed-effects model for repeated measures approach on a modified intent-to-treat population. Safety outcomes were summarized descriptively. RESULTS: Efficacy analyses were based on 400 patients (placebo = 200, vilazodone = 200); 76% completed the study (placebo = 81%, vilazodone = 71%). The least squares mean difference (95% CI) in total score change from baseline to week 8 was statistically significant for vilazodone versus placebo on the HARS (-2.20 [-3.72 to -0.68]; P = .0048) and on the SDS (-1.89 [-3.52 to -0.26]; P = .0236). Treatment-emergent adverse events reported in ≥ 5% of vilazodone patients and at least twice the rate of placebo were nausea, diarrhea, dizziness, fatigue, delayed ejaculation, and erectile dysfunction. CONCLUSION: Statistically significant differences in favor of vilazodone 20-40 mg/d versus placebo were seen on all measures of anxiety and functional impairment in patients with GAD. Vilazodone was generally well tolerated, and no new safety concerns were noted. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01844115.
[Mh] Termos MeSH primário: Ansiolíticos/farmacologia
Transtornos de Ansiedade/tratamento farmacológico
Avaliação de Resultados (Cuidados de Saúde)
Serotoninérgicos/farmacologia
Cloridrato de Vilazodona/farmacologia
[Mh] Termos MeSH secundário: Adulto
Ansiolíticos/administração & dosagem
Ansiolíticos/efeitos adversos
Método Duplo-Cego
Seres Humanos
Meia-Idade
Serotoninérgicos/administração & dosagem
Serotoninérgicos/efeitos adversos
Cloridrato de Vilazodona/administração & dosagem
Cloridrato de Vilazodona/efeitos adversos
[Pt] Tipo de publicação:JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Anti-Anxiety Agents); 0 (Serotonin Agents); U8HTX2GK8J (Vilazodone Hydrochloride)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170605
[Lr] Data última revisão:
170605
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160528
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE
[do] DOI:10.4088/JCP.15m09885


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[PMID]:27040795
[Au] Autor:Oosting RS; Chan JSW; Olivier B; Banerjee P
[Ad] Endereço:Division of Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG Utrecht, The Netherlands. Electronic address: R.S.Oosting@uu.nl.
[Ti] Título:Vilazodone does not inhibit sexual behavior in male rats in contrast to paroxetine: A role for 5-HT1A receptors?
[So] Source:Neuropharmacology;107:271-277, 2016 Aug.
[Is] ISSN:1873-7064
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Vilazodone (VLZ) is a selective serotonin reuptake inhibitor (SSRI) and 5-HT1A receptor partial agonist approved for the treatment of major depressive disorder in adults. In preclinical studies, VLZ had significantly lower sexual side effects than SSRIs and reduced serotonin transporter (SERT) levels in forebrain regions. In the current study, once-daily paroxetine (PAR, 10 mg/kg), VLZ (10 mg/kg), PAR + buspirone (BUS, 3 mg/kg; a 5-HT1A partial agonist), or vehicle (VEH) was administered to male rats for 2 weeks then switched for 7 days (eg, PAR switched to VLZ, PAR + BUS, or VEH). Sexual behavior (eg, ejaculation frequency and latency) was evaluated 1-hr postdose on days 1, 7, 14, and 21. After 2 weeks, treatment with PAR but not VLZ resulted in a significant decrease in sexual behavior. In a 30-min test, the range of ejaculation frequency was 3.08-3.5 with VLZ and 1.00-1.92 with PAR (P < 0.05 vs VEH). After switching from PAR to VEH, PAR + BUS, or VEH, sexual behaviors were normalized to control levels. In contrast, the switch from VLZ to PAR resulted in reduced sexual behaviors. This preclinical study showed that unlike PAR, an SSRI with no 5-HT1A receptor activity, initial treatment with VLZ did not result in sexual side effects at therapeutically relevant doses. Results in male rats switched from PAR to VLZ or PAR + BUS strongly suggest that activation of 5-HT1A receptors may mitigate the sexual side effects associated with conventional SSRIs.
[Mh] Termos MeSH primário: Paroxetina/farmacologia
Receptor 5-HT1A de Serotonina/fisiologia
Agonistas de Receptores 5-HT1 de Serotonina/farmacologia
Inibidores da Captação de Serotonina/farmacologia
Comportamento Sexual Animal/efeitos dos fármacos
Cloridrato de Vilazodona/farmacologia
[Mh] Termos MeSH secundário: Animais
Esquema de Medicação
Agonismo Parcial de Drogas
Feminino
Masculino
Ratos
Ratos Wistar
Comportamento Sexual Animal/fisiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Serotonin 5-HT1 Receptor Agonists); 0 (Serotonin Uptake Inhibitors); 112692-38-3 (Receptor, Serotonin, 5-HT1A); 41VRH5220H (Paroxetine); U8HTX2GK8J (Vilazodone Hydrochloride)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:170912
[Lr] Data última revisão:
170912
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160405
[St] Status:MEDLINE


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[PMID]:26971593
[Au] Autor:Sahli ZT; Banerjee P; Tarazi FI
[Ad] Endereço:a Department of Psychiatry and Neuroscience Program , Harvard Medical School, McLean Hospital , Belmont , MA , USA.
[Ti] Título:The Preclinical and Clinical Effects of Vilazodone for the Treatment of Major Depressive Disorder.
[So] Source:Expert Opin Drug Discov;11(5):515-23, 2016.
[Is] ISSN:1746-045X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: Major depressive disorder (MDD) is the leading cause of disability worldwide, and according to the STAR*D trial, only 33% of patients with MDD responded to initial drug therapy. Augmentation of the leading class of antidepressant treatment, selective serotonin reuptake inhibitors (SSRIs), with the 5-HT1A receptor agonist buspirone has been shown to be effective in treating patients that do not respond to initial SSRI therapy. This suggests that newer treatments may improve the clinical picture of MDD. The US Food and Drug Administration (FDA) approved the antidepressant drug vilazodone (EMD 68843), a novel SSRI and 5-HT1A receptor partial agonist. Vilazodone has a half-life between 20-24 hours, reaches peak plasma concentrations at 3.7-5.3 hours, and is primarily metabolized by the hepatic CYP450 3A4 enzyme system. AREAS COVERED: The authors review the preclinical and clinical profile of vilazodone. The roles of serotonin, the 5-HT1A receptor, and current pharmacotherapy approaches for MDD are briefly reviewed. Next, the preclinical pharmacological, behavioral, and physiological effects of vilazodone are presented, followed by the pharmacokinetic properties and metabolism of vilazodone in humans. Last, a brief summary of the main efficacy, safety, and tolerability outcomes of clinical trials of vilazodone is provided. EXPERT OPINION: Vilazodone has shown efficacy versus placebo in improving depression symptoms in several double-blind, placebo-controlled trials. The long-term safety and tolerability of vilazodone treatment has also been established. Further studies are needed that directly compare patients treated with an SSRI (both with and without an adjunctive 5-HT1A partial agonist) versus patients treated with vilaozodone.
[Mh] Termos MeSH primário: Antidepressivos/uso terapêutico
Transtorno Depressivo Maior/tratamento farmacológico
Agonistas de Receptores 5-HT1 de Serotonina/uso terapêutico
Inibidores da Captação de Serotonina/uso terapêutico
Cloridrato de Vilazodona/uso terapêutico
[Mh] Termos MeSH secundário: Animais
Antidepressivos/farmacologia
Seres Humanos
Agonistas de Receptores 5-HT1 de Serotonina/farmacologia
Inibidores da Captação de Serotonina/farmacologia
Cloridrato de Vilazodona/farmacologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Antidepressive Agents); 0 (Serotonin 5-HT1 Receptor Agonists); 0 (Serotonin Uptake Inhibitors); U8HTX2GK8J (Vilazodone Hydrochloride)
[Em] Mês de entrada:1612
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160315
[St] Status:MEDLINE
[do] DOI:10.1517/17460441.2016.1160051


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[PMID]:26938965
[Au] Autor:Citrome L
[Ad] Endereço:Psychiatry & Behavioral Sciences, New York Medical College, Valhalla, NY, USA. Electronic address: citrome@cnsconsultant.com.
[Ti] Título: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.
[So] Source:J Affect Disord;196:225-33, 2016 May 15.
[Is] ISSN:1573-2517
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo: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). Response was the efficacy outcome of interest, defined as a≥50% reduction from baseline on the Montgomery-Asberg Depression Rating Scale or Hamilton Depression Rating Scale. The tolerability outcome of interest was discontinuation because of an adverse event. Number needed to treat (NNT) and number needed to harm (NNH) for these outcomes vs. placebo were calculated, as well as likelihood to be helped or harmed (LHH) to contrast efficacy vs. tolerability. RESULTS: The analysis included 8 studies for duloxetine, 3 studies for escitalopram, 5 studies for levomilnacipran, 1 study for sertraline, 4 studies for venlafaxine, 2 studies for vilazodone, and 11 studies for vortioxetine. NNTs for response vs. placebo were 6 (95% CI 5-8), 7 (5-11), 10 (8-16), 6 (4-13), 6 (5-9), 8 (6-16), and 9 (7-11), respectively. NNHs for discontinuation because of an adverse event vs. placebo were 25 (17-51), 31 (19-92), 19 (14-27), 7 (5-12), 8 (7-11), 27 (15-104), and 43 (28-91), respectively. LHH values contrasting response vs. discontinuation because of an adverse event were 4.3, 4.6, 1.8, 1.2, 1.4, 3.3, and 5.1 respectively. LIMITATIONS: Subjects were all participants in carefully designed and executed clinical trials and may not necessarily reflect patients in clinical settings who may have complex psychiatric and non-psychiatric comorbidities. The measured outcomes come from different studies and thus comparisons are indirect. CONCLUSIONS: Vortioxetine demonstrates similar efficacy to that observed for duloxetine, escitalopram, levomilnacipran, sertraline, venlafaxine, and vilazodone, however overall tolerability as measured by discontinuation because of an adverse event differs. Vortioxetine is 5.1 times more likely to be associated with response than discontinuation because of an adverse event when compared to placebo.
[Mh] Termos MeSH primário: Antidepressivos/uso terapêutico
Citalopram/uso terapêutico
Transtorno Depressivo Maior/tratamento farmacológico
Cloridrato de Duloxetina/uso terapêutico
Sertralina/uso terapêutico
Cloridrato de Venlafaxina/uso terapêutico
Cloridrato de Vilazodona/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Feminino
Seres Humanos
Masculino
Meia-Idade
Escalas de Graduação Psiquiátrica
Inibidores da Captação de Serotonina/uso terapêutico
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T; REVIEW
[Nm] Nome de substância:
0 (Antidepressive Agents); 0 (Serotonin Uptake Inhibitors); 0DHU5B8D6V (Citalopram); 7D7RX5A8MO (Venlafaxine Hydrochloride); 9044SC542W (Duloxetine Hydrochloride); QUC7NX6WMB (Sertraline); U8HTX2GK8J (Vilazodone Hydrochloride)
[Em] Mês de entrada:1612
[Cu] Atualização por classe:161230
[Lr] Data última revisão:
161230
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160304
[St] Status:MEDLINE


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[PMID]:26758283
[Au] Autor:Oosting RS; Chan JS; Olivier B; Banerjee P; Choi YK; Tarazi F
[Ad] Endereço:Division of Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG, Utrecht, The Netherlands. R.S.Oosting@uu.nl.
[Ti] Título:Differential effects of vilazodone versus citalopram and paroxetine on sexual behaviors and serotonin transporter and receptors in male rats.
[So] Source:Psychopharmacology (Berl);233(6):1025-34, 2016 Mar.
[Is] ISSN:1432-2072
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:RATIONALE: Sexual side effects are commonly associated with selective serotonin reuptake inhibitor (SSRI) treatment. Some evidence suggest that activation of 5-HT1A receptors attenuates SSRI-induced sexual dysfunction. OBJECTIVE: This study in male rats compared the effects of vilazodone, an antidepressant with SSRI and 5-HT1A receptor partial agonist activity, with other prototypical SSRIs (citalopram and paroxetine) on sexual behaviors and 5-HT receptors (5-HT1A and 5-HT2A) and transporter (5-HTT) levels in select forebrain regions of the limbic system using quantitative autoradiography. METHODS: Rats received vilazodone (1, 3, and 10 mg/kg), citalopram (10 and 30 mg/kg), or paroxetine (10 mg/kg) treatment for 14 days. Sexual behaviors (frequency and latency of mounts, intromissions, and ejaculations) were measured in the presence of an estrous female rat on days 1 (acute), 7 (subchronic), and 14 (chronic). RESULTS: Vilazodone-treated rats exhibited no sexual dysfunction compared with controls; in contrast, the citalopram- and paroxetine-treated rats exhibited impaired copulatory and ejaculatory behaviors after subchronic and chronic treatments. Chronic vilazodone treatment markedly decreased 5-HT1A receptor levels in cortical and hippocampal regions, while the SSRIs increased levels of this receptor in similar regions. All chronic treatments reduced 5-HTT levels across the forebrain; however, the magnitude of the decrease was considerably smaller for vilazodone than for the SSRIs. CONCLUSIONS: The current studies showed that chronic treatment with vilazodone, in contrast to citalopram and paroxetine, was not associated with diminished sexual behaviors in male rats, which may be related to the differential effects of vilazodone on 5-HT1A receptor and 5-HTT levels relative to conventional SSRIs.
[Mh] Termos MeSH primário: Encéfalo/efeitos dos fármacos
Citalopram/farmacologia
Paroxetina/farmacologia
Receptores de Serotonina/metabolismo
Proteínas da Membrana Plasmática de Transporte de Serotonina/metabolismo
Inibidores da Captação de Serotonina/farmacologia
Comportamento Sexual/efeitos dos fármacos
Cloridrato de Vilazodona/farmacologia
[Mh] Termos MeSH secundário: Animais
Antidepressivos/farmacologia
Encéfalo/metabolismo
Masculino
Ratos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Nm] Nome de substância:
0 (Antidepressive Agents); 0 (Receptors, Serotonin); 0 (Serotonin Plasma Membrane Transport Proteins); 0 (Serotonin Uptake Inhibitors); 0DHU5B8D6V (Citalopram); 41VRH5220H (Paroxetine); U8HTX2GK8J (Vilazodone Hydrochloride)
[Em] Mês de entrada:1610
[Cu] Atualização por classe:170220
[Lr] Data última revisão:
170220
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160114
[St] Status:MEDLINE
[do] DOI:10.1007/s00213-015-4198-1



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