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

Phil Lee, Liang Shu, Xiufeng Xu, Chuan Yue Wang, Min-Soo Lee, Chia Yih Liu, Jin Pyo Hong, Sandra Ruschel, Joel Raskin, Samuel A. Colman, Gavan A. Harrison

Research output: Contribution to journalArticle

45 Citations (Scopus)

Abstract

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 (HAMD17) using a non-inferiority test with a margin of 2.2. Secondary efficacy measures included the HAMD17 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 HAMD17 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.

Original languageEnglish
Pages (from-to)295-307
Number of pages13
JournalPsychiatry and Clinical Neurosciences
Volume61
Issue number3
DOIs
Publication statusPublished - 2007 Jun 1

Fingerprint

Paroxetine
Major Depressive Disorder
Korea
Taiwan
Brazil
China
Vital Signs
Therapeutics
Electrocardiography
Safety
Weights and Measures
Pain Measurement
Back Pain
Duloxetine Hydrochloride
Visual Analog Scale
Nausea
Anxiety
Confidence Intervals
Depression
Equipment and Supplies

Keywords

  • Asia
  • Duloxetine
  • Major depressive disorder
  • MDD
  • Paroxetine

ASJC Scopus subject areas

  • Neuroscience(all)
  • Neurology
  • Clinical Neurology
  • Psychiatry and Mental health

Cite this

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. / Lee, Phil; Shu, Liang; Xu, Xiufeng; Wang, Chuan Yue; Lee, Min-Soo; Liu, Chia Yih; Hong, Jin Pyo; Ruschel, Sandra; Raskin, Joel; Colman, Samuel A.; Harrison, Gavan A.

In: Psychiatry and Clinical Neurosciences, Vol. 61, No. 3, 01.06.2007, p. 295-307.

Research output: Contribution to journalArticle

Lee, Phil ; Shu, Liang ; Xu, Xiufeng ; Wang, Chuan Yue ; Lee, Min-Soo ; Liu, Chia Yih ; Hong, Jin Pyo ; Ruschel, Sandra ; Raskin, Joel ; Colman, Samuel A. ; Harrison, Gavan A. / 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. In: Psychiatry and Clinical Neurosciences. 2007 ; Vol. 61, No. 3. pp. 295-307.
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