Efficacy and Safety of Desvenlafaxine 50 mg/d in a Randomized, Placebo-Controlled Study of Perimenopausal and Postmenopausal Women With Major Depressive Disorder

Clayton, Anita H.; Kornstein, Susan G.; Dunlop, Boadie W.; Focht, Kristen; Musgnung, Jeff; Ramey, Tanya; Bao, Weihang; Ninan, Philip T.

doi:10.4088/jcp.12m08065

Cited by 52 publications

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“…Individual patient data from seven multicenter, randomized, double-blind, placebo-controlled fixed-dose studies of desvenlafaxine 50 mg/day in MDD were pooled (Table 1) (Boyer et al, 2008;Liebowitz et al, 2008;Tourian et al, 2009;Dunlop et al, 2011;Clayton et al, 2013;Iwata et al, 2013;Liebowitz et al, 2013). The desvenlafaxine 50 mg/day dose was used for this analysis because it is the recommended therapeutic dose (Pristiq® package insert, 2013).…”

Section: Pooled Data Setmentioning

confidence: 99%

“…All included studies enrolled adult (aged ≥18 or ≥20 years in Japan) outpatients with a diagnosis of MDD, single or recurrent episode of at least 30 days, consistent with criteria from the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (American Psychiatric Association, 1994) (DSM-IV) or the DSM-IV, text revision (American Psychiatric Association, 2000). One study enrolled perimenopausal and postmenopausal women, aged 40-70 years (Clayton et al, 2013). For six studies, eligible patients had screening and baseline HAM-D 17 total scores of at least 20, a HAM-D 17 depressed mood (Item 1) score of at least 2, and a Clinical Global Impressions-Severity (CGI-S) Scale score of at least 4 at screening and baseline.…”

Section: Patient Populationmentioning

confidence: 99%

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The effect of desvenlafaxine 50 mg/day on a subpopulation of anxious/depressed patients: a pooled analysis of seven randomized, placebo‐controlled studies

Kornstein

Guico-Pabia

Fayyad

2014

Human Psychopharmacology

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Section: Pooled Data Setmentioning

confidence: 99%

Section: Patient Populationmentioning

confidence: 99%

The effect of desvenlafaxine 50 mg/day on a subpopulation of anxious/depressed patients: a pooled analysis of seven randomized, placebo‐controlled studies

Kornstein

Guico-Pabia

Fayyad

2014

Human Psychopharmacology

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“…In addition, we found in 2 reviews an unpublished report with the code name Des 223, which was also included in the main analysis. 3 further placebocontrolled RCTs were identified [22][23][24]: 2 of them included only perimenopausal and postmenopausal women, while the third included only patients who were employed. These 3 last trials used a slightly different design: They recruited patients based on their MADRS score (a cutoff of 22 or 25), but estimated the response rates based on HAM-D scores in a subpopulation of the original sample, which had an initial HAM-D score above 18.…”

Section: Search Resultsmentioning

confidence: 99%

Desvenlafaxine for the Acute Treatment of Depression: A Systematic Review and Meta-analysis

Laoutidis

Kioulos

2015

Pharmacopsychiatry

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cally relevant parameters for efficacy (response and remission rates) and tolerability (discontinuation rates and discontinuation due to adverse effects), and we will estimate effect sizes for various doses with the aim of detecting a possible dose-dependent effect. Further, we compare desvenlafaxine with other antidepressant agents, if any head-to-head trials are available. Methods ▼ Search strategyThe inclusion criteria for the studies were the following: Double-blind, randomized controlled trials (RCTs), either placebo-controlled or headto-head trials. We searched for studies in the electronic databases PubMed, EMBASE and the Central Register of Controlled Trials of the Cochrane Library. The only search term was "desvenlafaxine". The applied limits of the search were that the articles should have been published by December 31, 2014. We further searched through the reference lists of reviews and related articles to identify any additional studies. Introduction ▼Desvenlafaxine is a relatively novel agent that was approved in 2008 in the USA for the treatment of major depressive disorder. It is the main metabolite of venlafaxine, a selective serotonin and norepinephrine reuptake inhibitor, which is considered to be one of the most effective antidepressants today [1]. Desvenlafaxine appears to share the same pharmacodynamic properties as the parent substance [2]. The efficacy of active metabolites is not self-evident and should not be taken for granted; for example, the active metabolite of clozapine -the most effective antipsychotic drug [3] -was not found to be effective in the treatment of schizophrenia. Several trials have been conducted so far on the efficacy of desvenlafaxine in the treatment of major depressive disorder and an early meta-analysis showed significant results in both primary (HAM-D 17 scores) and secondary (response and remission rates) outcomes [4]. The efficacy of desvenlafaxine has been tested further in more recent studies, thus making it imperative to update the first review. The objective of our review is to give an overview of the existing literature; we focus solely on clini- The aim of the present review is to provide an overview of the existing trials with desvenlafaxine and assess its overall efficacy and tolerability. Methods: We searched in PubMed, EMBASE and the Cochrane Library for eligible studies (double-blind randomized control trials). A random effects model was used for the estimation of effect sizes. Results: 17 trials were found in total. In the placebo-controlled trials the overall risk ratio

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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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Efficacy and Safety of Desvenlafaxine 50 mg/d in a Randomized, Placebo-Controlled Study of Perimenopausal and Postmenopausal Women With Major Depressive Disorder

Abstract: ClinicalTrials.gov identifier: NCT01121484.

Cited by 52 publications

References 0 publications

The effect of desvenlafaxine 50 mg/day on a subpopulation of anxious/depressed patients: a pooled analysis of seven randomized, placebo‐controlled studies

The effect of desvenlafaxine 50 mg/day on a subpopulation of anxious/depressed patients: a pooled analysis of seven randomized, placebo‐controlled studies

Desvenlafaxine for the Acute Treatment of Depression: A Systematic Review and Meta-analysis

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

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