Desvenlafaxine 50 and 100 mg/d in the treatment of major depressive disorder: An 8-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial and a post hoc pooled analysis of three studies

Tourian, Karen A.; Padmanabhan, S. Krishna; Groark, James; Brisard, Claudine; Farrington, D. L.

doi:10.1016/j.clinthera.2009.07.006

Cited by 61 publications

(56 citation statements)

References 25 publications

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“…In the RCT that reported data about the comparison between SNRI and placebo, withdrawal symptoms were significantly higher after discontinuation of venlafaxine [11,12,19,22] and desvenlafaxine [15,16,23,34], whereas they did not differ from placebo in most of the trials on duloxetine [9,10,17,22,[24][25][26]33] or in the studies on levomilnacipran [14] and milnacipran [13]. The duration of treatment with venlafaxine or desvenlafaxine was as short as 2 months [11,15,16,23].…”

Section: Discussionmentioning

confidence: 99%

“…The duration of treatment with venlafaxine or desvenlafaxine was as short as 2 months [11,15,16,23].…”

Section: Discussionmentioning

confidence: 99%

“…Nausea and dizziness were the most frequently reported symptoms. Tourian et al [23] compared desvenlafaxine at 50 mg/day, desvenlafaxine at 100 mg/day, and duloxetine at 60 mg/day with placebo. Significantly higher mean DESS scores [20] were reported for duloxetine at 60 mg/day and desvenlafaxine at 50 mg/day, and for duloxetine at 60 mg/day and desvenlafaxine at 100 mg/day after 1 and 2 weeks of the taper treatment period.…”

Section: Multiple Drugs and Placebo Comparisonsmentioning

confidence: 99%

See 2 more Smart Citations

Withdrawal Symptoms after Serotonin-Noradrenaline Reuptake Inhibitor Discontinuation: Systematic Review

Fava

Benasi

Lucente

et al. 2018

Psychother Psychosom

163

146

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Background: Serotonin-noradrenaline reuptake inhibitors (SNRI) are widely used in medical practice. Their discontinuation has been associated with a wide range of symptoms. The aim of this paper is to identify the occurrence, frequency, and features of withdrawal symptoms after SNRI discontinuation. Methods: PRISMA guidelines were followed to conduct a systematic review. Electronic databases included PubMed, the Cochrane Library, Web of Science, and MEDLINE from the inception of each database to June 2017. Titles, abstracts, and topics were searched using a combination of the following terms: “duloxetine” OR “venlafaxine” OR “desvenlafaxine” OR “milnacipran” OR “levomilnacipran” OR “SNRI” OR “second generation antidepressant” OR “serotonin norepinephrine reuptake inhibitor” AND “discontinuation” OR “withdrawal” OR “rebound.” Only published trials in the English language were included. Results: Sixty-one reports met the criteria for inclusion. There were 22 double-blind randomized controlled trials, 6 studies where patients were treated in an open fashion and then randomized to a double-blind controlled phase, 8 open trials, 1 prospective naturalistic study, 1 retrospective study, and 23 case reports. Withdrawal symptoms occurred after discontinuation of any type of SNRI. The prevalence of withdrawal symptoms varied across reports and appeared to be higher with venlafaxine. Symptoms typically ensued within a few days from discontinuation and lasted a few weeks, also with gradual tapering. Late onset and/or a longer persistence of disturbances occurred as well. Conclusions: Clinicians need to add SNRI to the list of drugs potentially inducing withdrawal symptoms upon discontinuation, together with other types of psychotropic drugs. The results of this study challenge the use of SNRI as first-line treatment for mood and anxiety disorders.

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Section: Discussionmentioning

confidence: 99%

“…The duration of treatment with venlafaxine or desvenlafaxine was as short as 2 months [11,15,16,23].…”

Section: Discussionmentioning

confidence: 99%

Section: Multiple Drugs and Placebo Comparisonsmentioning

confidence: 99%

See 1 more Smart Citation

Withdrawal Symptoms after Serotonin-Noradrenaline Reuptake Inhibitor Discontinuation: Systematic Review

Fava

Benasi

Lucente

et al. 2018

Psychother Psychosom

163

146

View full text Add to dashboard Cite

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“…Outpatients who met diagnostic criteria for MDD and presented with HAM-D 17 total scores of greater than or equal to 20 at study entry were enrolled in the 10 placebo-controlled, short-term, desvenlafaxine clinical trials (conducted in the USA and at various international sites) that were included in these analyses (DeMartinis et al, 2007;Liebowitz et al, 2007;Septien-Velez et al, 2007;Boyer et al, 2008;Lieberman et al, 2008;Liebowitz et al, 2008;Feiger et al, 2009;Tourian et al, 2009;Kornstein et al, 2010). For all analyses, the individual desvenlafaxine dose groups (intent-to-treat population) were pooled.…”

Section: Patientsmentioning

confidence: 99%

Assessing the relationship between functional impairment/recovery and depression severity

Guico-Pabia

Fayyad

Soares

2012

International Clinical Psychopharmacology

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The objective of this study was to explore the relationship between assessments of functional impairment, emotional well-being, and depression symptoms. Data were pooled from 3530 outpatients with major depressive disorder enrolled in 10 desvenlafaxine clinical trials. The primary outcome measures included (a) the 17-item Hamilton Rating Scale for Depression (HAM-D17) as a measure of depressive symptom severity and (b) the Sheehan Disability Scale (SDS) and five-item World Health Organization Well-Being Index (WHO-5) as measures of functional impairment and well-being. A linear regression model was used to identify the SDS and WHO-5 values that equate to the predetermined clinically relevant three-point difference between active treatment and placebo on the HAM-D17. A receiver operating characteristic analysis was conducted to determine the SDS score that equates to a remission of depression symptoms (i.e. HAM-D17≤7). An approximate three-point difference between active treatment and placebo on the SDS (2.8) and WHO-5 (2.5) was determined to be clinically relevant in relation to improvements in depressive symptoms. An SDS of less than or equal to 7 was equivalent to a remission of depression symptoms, providing a definition of functional remission. A better understanding of the relationship between depressive symptoms and functional impairment and well-being may provide clinicians with a more comprehensive means of assessing treatment effects in major depressive disorder.

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“…The efficacy and tolerability of the 50 and 100 mg/day doses of desvenlafaxine have been assessed for the treatment of MDD in short-term and longer-term clinical trials (DeMartinis et al, 2007;Boyer et al, 2008;Liebowitz et al, 2008;Tourian et al, 2009;Dunlop et al, 2011;Clayton et al, 2013aClayton et al, , 2015Iwata et al, 2013;Liebowitz et al, 2013;Rosenthal et al, 2013). Sexual function was assessed prospectively using the Arizona Sexual Experiences Scale (ASEX) in several of the short-term trials (Dunlop et al, 2011;Iwata et al, 2013;Liebowitz et al, 2013;Clayton et al, 2015).…”

Section: Introductionmentioning

confidence: 99%

Effects of 50 and 100 mg desvenlafaxine versus placebo on sexual function in patients with major depressive disorder

Clayton

Hwang

Kornstein

et al. 2015

International Clinical Psychopharmacology

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The primary objective of this post-hoc analysis was to evaluate the effect of short-term treatment with desvenlafaxine versus placebo on sexual dysfunction (SD), assessed from Arizona Sexual Experiences Scale scores, in adult outpatients with major depressive disorder. Data from three randomized, double-blind, placebo-controlled trials of 50 or 100 mg/day desvenlafaxine for major depressive disorder were pooled. SD status, determined from Arizona Sexual Experiences Scale scores, was assessed at baseline and week 8, last observation carried forward. Subgroup analyses addressed the effects of sex, baseline SD, and antidepressant response. At week 8, last observation carried forward (n=1562), SD rates were 54, 47, and 49% for 50 mg/day desvenlafaxine, 100 mg/day desvenlafaxine, and placebo, respectively [adjusted odds ratios (95% confidence interval) vs. placebo: 1.205 (0.928, 1.564) and 1.129 (0.795, 1.604), respectively]. The treatment by baseline SD interaction approached statistical significance (P=0.0663), mainly driven by poorer scores for desvenlafaxine versus placebo in the 100 mg group. Treatment by sex interactions were not statistically significant. Small but statistically significant treatment by sex interactions were observed for sex drive (P=0.0011) and ease of erection/lubrication (P=0.0151). Although there was no overall effect of desvenlafaxine on SD, a treatment by baseline SD interaction was suggested for 100 mg desvenlafaxine.

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Desvenlafaxine 50 and 100 mg/d in the treatment of major depressive disorder: An 8-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial and a post hoc pooled analysis of three studies

Cited by 61 publications

References 25 publications

Withdrawal Symptoms after Serotonin-Noradrenaline Reuptake Inhibitor Discontinuation: Systematic Review

Withdrawal Symptoms after Serotonin-Noradrenaline Reuptake Inhibitor Discontinuation: Systematic Review

Assessing the relationship between functional impairment/recovery and depression severity

Effects of 50 and 100 mg desvenlafaxine versus placebo on sexual function in patients with major depressive disorder

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