The Effect of Initial Duloxetine Dosing Strategy on Nausea in Korean Patients with Major Depressive Disorder.
- Author:
Min Soo LEE
1
;
Yong Min AHN
;
Seockhoon CHUNG
;
Richard WALTON
;
Joel RASKIN
;
Mun Sung KIM
Author Information
1. Department of Psychiatry, Korea University College of Medicine, Seoul, Republic of Korea.
- Publication Type:Clinical Trial ; Original Article ; Randomized Controlled Trial
- Keywords:
Clinical trial;
Phase IV;
Major depressive disorder;
Duloxetine;
Korea;
Nausea;
Serotonin-norepinephrine reuptake inhibitor
- MeSH:
Adult;
Depression;
Depressive Disorder, Major;
Eating;
Humans;
Korea;
Nausea;
Outcome Assessment (Health Care);
Thiophenes;
Duloxetine Hydrochloride
- From:Psychiatry Investigation
2012;9(4):391-399
- CountryRepublic of Korea
- Language:English
-
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.
