Comparison of efficacy and safety of milnacipran and fluoxetine in Korean patients with major depression.
OBJECTIVE
To compare efficacy and safety of milnacipran and fluoxetine in a population of Korean patients with major depression.


METHODS
The design was a multi-centre, randomised, comparative clinical study. Patients with major depression (DSM-IV diagnostic criteria) scoring over 17 points on the 17-item Hamilton Depression Scale (HAM-D) and over 21 points on the Montgomery-Asberg Depression Rating Scale (MADRS) were recruited and randomised to receive milnacipran (50 mg/day increasing after 1 week to 100 mg/day) or fluoxetine (20 mg/day) for 6 weeks. All previous medication was stopped at least 7 days before entry into the study. Patients were evaluated (HAM-D, MADRS and clinical global impression scale, CGI) at baseline and after 1, 2, 4 and 6 weeks of treatment. All adverse events which developed during the study period were recorded.


RESULTS
70 patients (milnacipran 39; fluoxetine 31) were included in the study. Total score on both HAM-D, MADRS and CGI decreased significantly in both groups after 1 week and continued to decrease throughout the study. There was no significant difference between the two groups for any measurement at any time point. Both antidepressants were well tolerated. In the milnacipran group, 13 patients reported 28 adverse reactions, and in the fluoxetine group 11 patients reported 18 adverse reactions. Two patients discontinued due to adverse events in the milnacipran group and three in the fluoxetine group. There were no clinically significant modifications in vital signs, routine blood laboratory tests, biochemistry or ECG throughout the study. Nausea and headache were the most frequently reported adverse events with milnacipran while digestive disturbances, diarrhoea and insomnia were more common with fluoxetine.


CONCLUSIONS
Milnacipran, like fluoxetine, was found to be effective and well tolerated for the treatment of major depression in this population of depressed Korean patients. Principal limitations of the study were its open design, its small sample size and its relatively short duration.
Lee
Min-Soo
MS
Department of Psychiatry, College of Medicine, Korea University, Seoul, Korea. leeminso@korea.ac.kr
Ham
Byung Joo
BJ
Kee
Baik Seok
BS
Kim
Jung-Bum
JB
Yeon
Byeong Kil
BK
Oh
Kang-Seob
KS
Oh
Byoung Hoon
BH
Lee
Chul
C
Jung
Han Yong
HY
Chee
Ik-Seung
IS
Choe
Byeong Moo
BM
Paik
In Ho
IH
D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000627:therapeutic use*; D003521:Cyclopropanes / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy*; D005260:Female; D005473:Fluoxetine / Q000627:therapeutic use*; D006801:Humans; D007723:Korea / Q000208:ethnology; D008297:Male; D008875:Middle Aged; D000078764:Milnacipran; D012449:Safety; D016896:Treatment Outcome
D000928:Antidepressive Agents; D003521:Cyclopropanes; D005473:Fluoxetine; D000078764:Milnacipran