Psychiatry Investig.  2012 Dec;9(4):391-399.

The Effect of Initial Duloxetine Dosing Strategy on Nausea in Korean Patients with Major Depressive Disorder

• Lee MS
• Ahn YM
• Chung S
• Walton R
• Raskin J
• Kim MS

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 > or =15, received open-label 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.

Keyword

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

MeSH Terms

Adult
Depression
Depressive Disorder, Major
Eating
Humans
Korea
Nausea
Outcome Assessment (Health Care)
Thiophenes
Duloxetine Hydrochloride
Thiophenes