Evaluation of the effect of duloxetine treatment on functioning as measured by the Sheehan disability scale

Abstract

The purpose of this work is to describe the effect of duloxetine on functioning as measured by the Sheehan disability scale (SDS) compared with placebo in patients with major depressive disorder (MDD). Pooled data from six randomized, parallel, double-blind, placebo-controlled duloxetine studies in adult MDD patients were analyzed at the short-term (7-13 weeks) and the long-term (>24 weeks) endpoint. The primary variable was the SDS total score. Secondary variables included functional remission (SDS total ≤ 6) rates, Hamilton rating scale for depression total score, and pain visual analog scale. Analysis of covariance and logistic regression methods were used to assess differences in treatment and identify prognostic baseline factors. In total, 2496 patients (1424 duloxetine; 1072 placebo) were included. The between-treatment difference of -2.52 between duloxetine and placebo in the SDS total score at the short-term endpoint was statistically significant in favor of duloxetine vs. placebo (95% confidence interval: -3.17, -1.87; P < 0.001). The endpoint functional remission rates were 39.5% with duloxetine and 28.7% with placebo. Time since first depression episode, antidepressant pretreatment (yes/no), baseline visual analog scale pain (≤30 / >30 mm), and sex were significant prognostic factors. The effect of duloxetine was maintained at the long-term endpoint. Duloxetine is effective in improving MDD patients' functioning. Further antidepressant studies focusing on functioning would be helpful.

The effect of vortioxetine on overall patient functioning in patients with major depressive disorder

“…The SDS is a validated measure of functional impairment that has demonstrated sensitivity to impairment and the effects of treatment across a wide range of disorders, including MDD (Sheehan & Sheehan, 2008). The SDS has been used to assess functional improvement in association with improvements in depressive symptoms for duloxetine (Mancini et al., 2012; Oakes et al., 2012; Sheehan et al., 2011; Wise et al., 2008), desvenlafaxine (Dunlop et al., 2011; Guico‐Pabia et al., 2012; Soares et al., 2009), paroxetine (Wise et al., 2008), bupropion (Hewett et al., 2010; Soczynska et al., 2014), escitalopram (Romera et al., 2012; Soczynska et al., 2014), venlafaxine (Fann et al., 2015; Hewett et al., 2010), levomilnacipran (Asnis et al., 2013; Sambunaris, Bose, et al., 2014), and agomelatine (Montgomery, Nielsen, et al., 2014; Zajecka et al., 2010) with results that have been variable with respect to clinical significance; however, many of these antidepressants showed significant differences versus placebo in the change from baseline versus placebo in the SDS total score when patients were stratified by baseline depressive symptom severity. A recent pooled analysis showed that treatment with duloxetine ( n  = 1,029) and SSRIs ( n  = 835) resulted in significantly greater improvements in the SDS total score (∆ −1.9, p  <   .001; ∆ −1.7, p  <   .01, respectively) compared to placebo ( n  = 329).…”

“…(2008) and Sheehan et al. (2011) and which has been used in other studies of MDD to define functional remission (Mancini et al., 2012; Montgomery, Mansuy, et al., 2014; Sambunaris, Bose, et al., 2014; Sambunaris, Gommoll, et al., 2014; Soares et al., 2014). …”

Efficacy of levomilnacipran extended-release in improving functional impairment associated with major depressive disorder

“…Despite recent focus on assessing functional impairment as an important ‘real-world’ outcome of antidepressant treatment (Zimmerman et al , 2006; Sheehan and Sheehan, 2008; Soares et al , 2009; Langlieb and Guico-Pabia, 2010; Sheehan et al , 2011; Mancini et al , 2012), there have been relatively few studies examining whether there are baseline characteristics that predict the likelihood of improved functional impairment during treatment. One recent post-hoc analysis of a large pool of data from studies on the SNRI duloxetine versus placebo reported that female sex, a shorter time since the first depressive episode, absence of previous antidepressant use, and mild versus more severe pain were all prognostic factors for improved functioning following antidepressant treatment (Mancini et al , 2012).…”

“…One recent post-hoc analysis of a large pool of data from studies on the SNRI duloxetine versus placebo reported that female sex, a shorter time since the first depressive episode, absence of previous antidepressant use, and mild versus more severe pain were all prognostic factors for improved functioning following antidepressant treatment (Mancini et al , 2012). Guico-Pabia et al .…”

“…1) have been pooled to examine the effect of levomilnacipran ER versus placebo on functional impairment as measured using the Sheehan Disability Scale (SDS; Sheehan et al , 1996). As the likelihood of achieving symptomatic remission during treatment has been associated with various patient characteristics such as age, sex, and depression severity (Bosworth et al , 2002; Trivedi et al , 2006; Mancini et al , 2012), these characteristics were evaluated in this study for their potential association with improvement of functional impairment.…”