Premium
Once‐daily duloxetine 60 mg in the treatment of major depressive disorder: Multicenter, double‐blind, randomized, paroxetine‐controlled, non‐inferiority trial in China, Korea, Taiwan and Brazil
Author(s) -
LEE PHIL,
SHU LIANG,
XU XIUFENG,
WANG CHUAN YUE,
LEE MIN SOO,
LIU CHIAYIH,
HONG JIN PYO,
RUSCHEL SANDRA,
RASKIN JOEL,
COLMAN SAMUEL A,
HARRISON GAVAN A
Publication year - 2007
Publication title -
psychiatry and clinical neurosciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.609
H-Index - 74
eISSN - 1440-1819
pISSN - 1323-1316
DOI - 10.1111/j.1440-1819.2007.01666.x
Subject(s) - duloxetine , hamd , paroxetine , major depressive disorder , nausea , hamilton anxiety rating scale , psychology , randomized controlled trial , adverse effect , medicine , psychiatry , anxiety , physical therapy , antidepressant , mood , alternative medicine , pathology
The aim of the present paper was to compare the efficacy and safety of duloxetine with paroxetine in the acute treatment of major depressive disorder (MDD). In a randomized, double‐blind trial of 8 weeks active treatment, patients with non‐psychotic MDD were randomized to duloxetine 60 mg ( n = 238) or paroxetine 20 mg ( n = 240) once daily. Efficacy was primarily measured on change in the 17‐item Hamilton Rating Scale for Depression (HAMD 17 ) using a non‐inferiority test with a margin of 2.2. Secondary efficacy measures included the HAMD 17 subscales, Hamilton Rating Scale for Anxiety, Clinical Global Impressions–Severity, Patient Global Impressions–Improvement, Somatic Symptoms Inventory and Visual Analog Scales (VAS) for pain. Safety measures included treatment‐emergent adverse events (TEAE), vital signs, weight, laboratory analyses and electrocardiograms. Non‐inferiority of duloxetine to paroxetine was demonstrated because the upper bound of the confidence interval for mean difference in HAMD 17 change (0.71) was less than the non‐inferiority margin. Secondary efficacy end‐points did not differ significantly between treatments with the exception of VAS back pain, where the pooled mean was lower in the duloxetine group (17.1) compared with the paroxetine group (20.3, P = 0.048). No significant differences were observed in the number of early discontinuations and overall TEAE. However, significantly greater proportions of patients in the duloxetine group experienced nausea and palpitations. No clinically relevant changes in laboratory values, vital signs, weight or electrocardiograms were observed with either treatment. The present study verifies the utility of duloxetine as an efficacious and safe treatment for both emotional and physical symptoms of MDD in this predominantly Asian patient sample.