A double-blind, placebo-controlled study of edivoxetine as an adjunctive treatment for patients with major depressive disorder who are partial responders to selective serotonin reuptake inhibitor treatment

被引:14
|
作者
Ball, Susan [1 ,2 ]
Dellva, Mary Anne [1 ]
D'Souza, Deborah N. [3 ]
Marangell, Lauren B. [1 ,4 ]
Russell, James M. [1 ]
Goldberger, Celine [1 ]
机构
[1] Eli Lilly & Co, Lilly Corp Ctr, Indianapolis, IN 46285 USA
[2] Indiana Univ Sch Med, Dept Psychiat, Indianapolis, IN 46202 USA
[3] InVentiv Hlth Clin, Ann Arbor, MI 48108 USA
[4] Univ Texas Hlth Sci Ctr Houston, Houston, TX 77030 USA
关键词
Edivoxetine; Norepinephrine; Adjunctive treatment; Major depressive disorder; Efficacy; Safety; STAR-ASTERISK-D; QUESTIONNAIRE FASD; RESIDUAL SYMPTOMS; CLINICAL-PRACTICE; ANTIDEPRESSANT; REMISSION; SCALE; VALIDATION; GUIDELINES; ANXIETY;
D O I
10.1016/j.jad.2014.06.006
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Background: This phase 2 study examined the efficacy and tolerability of edivoxetine, a highly selective norepinephrine reuptake inhibitor, as an adjunctive treatment for patients with major depressive disorder (MDD) who have a partial response to selective serotonin reuptake inhibitor (SSRI) treatment. Methods: Study design consisted of double-blind, 10-week therapy of adjunctive edivoxetine (6-18 mg once daily) or adjunctive placebo with SSR1. Inclusion/entry criteria included partial response to current SSRI by investigator opinion and a GRID 17-item Hamilton Rating Scale for Depression (HAMD(17)) total score >= 16. The primary efficacy measure was the Montgomery-Asberg Depression Rating Scale (MADRS). Safety measures included treatment-emergent adverse events (TEAE) and vital signs. Results: For the primary evaluable population (n=63 for adjunctive edivoxetine and n=68 for adjunctive placebo), the treatment groups did not differ significantly on the primary outcome of change from baseline to week 8 in the MADRS total score; the effect size of edivoxetine treatment was 0.26. Significant treatment differences, favoring adjunctive edivoxetine (p <=.05), were shown for improvements in role functioning and the functional impact of fatigue. For the adjunctive edivoxetine randomized group (N=111), the most frequent TEAEs were hyperhidrosis (7.2%), nausea (7.2%), erectile dysfunction (6.3%) and testicular pain (6.3%). Hemodynamic changes were observed in blood pressure and pulse rate between treatment groups. Limitations: Study was underpowered for an alpha 2-sided 0.05 significance level for the primary outcome. Conclusions: For patients with MDD who had a partial response to SSRIs, adjunctive edivoxetine treatment was not statistically superior to adjunctive placebo on the primary outcome measure. However, pending further study, improved functioning and remission rate suggest a potential role for edivoxetine for patients with depression. (C) 2014 Elsevier B.V. All rights reserved.
引用
收藏
页码:215 / 223
页数:9
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