The effect of initial duloxetine dosing strategy on nausea in Korean patients with major depressive disorder

Min-Soo Lee, Yong Min Ahn, Seockhoon Chung, Richard Walton, Joel Raskin, Mun Sung Kim

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Objective: To assess the relative severity of nausea in patients from Korea with major depressive disorder (MDD) who were treated with duloxetine at low (30 mg) or high (60 mg) doses, with or without food, for the first week of an 8 week treatment. Methods: Adult patients (n=249), with MDD and a 17-item Hamilton Rating Scale for Depression (HAMD17) score of ≥15, received openlabel once daily duloxetine. At Week 0, patients were randomized to 4 groups: 30 mg with food (n=63), 60 mg with food (n=59), 30 mg without food (n=64), and 60 mg without food (n=63). At Week 1, all patients switched to duloxetine 60 mg for 7 weeks. The primary outcome measure was item 112 (nausea) of the Association for Methodology and Documentation in Psychiatry adverse event scale. Effectiveness was assessed by change in HAMD17 total score. Results: Overall, 94.4% (235/249) of patients completed Week 1 and 55.0% (137/249) of patients completed the study. For Week 1, nausea was significantly less severe for patients who received 30 mg compared with 60 mg duloxetine (p=0.003), regardless of food intake. In all groups, nausea severity was highest at Week 1 and declined throughout the study. HAMD17 score was reduced in all groups and the most common adverse event reported was nausea (145/249; 58.2%). Conclusion: To minimize nausea, Korean patients with MDD who require duloxetine treatment could be given 30 mg once daily, regardless of food, for the first week followed by 60 mg once daily for the course of therapy.

Original languageEnglish
Pages (from-to)391-399
Number of pages9
JournalPsychiatry Investigation
Volume9
Issue number4
DOIs
Publication statusPublished - 2012 Dec 1

Fingerprint

Major Depressive Disorder
Nausea
Food
Duloxetine Hydrochloride
Korea
Documentation
Psychiatry
Therapeutics
Eating
Outcome Assessment (Health Care)
Depression

Keywords

  • Clinical trial
  • Duloxetine
  • Korea
  • Major depressive disorder
  • Nausea
  • Phase IV
  • Serotonin-norepinephrine reuptake inhibitor

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Biological Psychiatry

Cite this

The effect of initial duloxetine dosing strategy on nausea in Korean patients with major depressive disorder. / Lee, Min-Soo; Ahn, Yong Min; Chung, Seockhoon; Walton, Richard; Raskin, Joel; Kim, Mun Sung.

In: Psychiatry Investigation, Vol. 9, No. 4, 01.12.2012, p. 391-399.

Research output: Contribution to journalArticle

Lee, Min-Soo ; Ahn, Yong Min ; Chung, Seockhoon ; Walton, Richard ; Raskin, Joel ; Kim, Mun Sung. / The effect of initial duloxetine dosing strategy on nausea in Korean patients with major depressive disorder. In: Psychiatry Investigation. 2012 ; Vol. 9, No. 4. pp. 391-399.
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AB - Objective: To assess the relative severity of nausea in patients from Korea with major depressive disorder (MDD) who were treated with duloxetine at low (30 mg) or high (60 mg) doses, with or without food, for the first week of an 8 week treatment. Methods: Adult patients (n=249), with MDD and a 17-item Hamilton Rating Scale for Depression (HAMD17) score of ≥15, received openlabel once daily duloxetine. At Week 0, patients were randomized to 4 groups: 30 mg with food (n=63), 60 mg with food (n=59), 30 mg without food (n=64), and 60 mg without food (n=63). At Week 1, all patients switched to duloxetine 60 mg for 7 weeks. The primary outcome measure was item 112 (nausea) of the Association for Methodology and Documentation in Psychiatry adverse event scale. Effectiveness was assessed by change in HAMD17 total score. Results: Overall, 94.4% (235/249) of patients completed Week 1 and 55.0% (137/249) of patients completed the study. For Week 1, nausea was significantly less severe for patients who received 30 mg compared with 60 mg duloxetine (p=0.003), regardless of food intake. In all groups, nausea severity was highest at Week 1 and declined throughout the study. HAMD17 score was reduced in all groups and the most common adverse event reported was nausea (145/249; 58.2%). Conclusion: To minimize nausea, Korean patients with MDD who require duloxetine treatment could be given 30 mg once daily, regardless of food, for the first week followed by 60 mg once daily for the course of therapy.

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