The Efficacy and Safety of Milnacipran in Patients with Major Depression: A comparison with Fluoxetine.
- Author:
Min Soo LEE
1
;
Byung Joo HAM
;
Baik Seok KEE
;
Jung Bum KIM
;
Byeong Kil YEON
;
Kang Seob OH
;
Byoung Hoon OH
;
Chul LEE
;
Han Yong JUNG
;
Ik Seung CHEE
;
Byeong Moo CHOE
;
In Ho PAIK
Author Information
1. Department of Psychiatry, College of Medicine, Korea University, Seoul, Korea. leeminso@Korea.ac.kr
- Publication Type:Multicenter Study ; Original Article ; Randomized Controlled Trial
- Keywords:
Milnacipran;
Fluoxetine;
Efficacy;
Safety
- MeSH:
Antidepressive Agents;
Chemistry;
Constipation;
Depression*;
Diagnostic and Statistical Manual of Mental Disorders;
Diarrhea;
Dihydroergotamine;
Dizziness;
Electrocardiography;
Fluoxetine*;
Headache;
Humans;
Incidence;
Nausea;
Sleep Initiation and Maintenance Disorders;
Vital Signs;
Vomiting
- From:Journal of Korean Neuropsychiatric Association
2004;43(4):415-424
- CountryRepublic of Korea
- Language:Korean
-
Abstract:
OBJECTIVES: This 6-week, open label randomized, multicenter study was conducted to evaluate the antidepressant effect and safety of milnacipran and fluoxetine in patients with major depression. METHODS: The study was done in patients with major depression diagnosed by DSM-IV who score > or =17 in 17 items Hamilton Rating Scale for Depression (17-item HAM-D) and score > or =25 in Montgomery and Asberg Depression Rating Scale (MADRS). A total of 87 patients were randomized to milnacipran group and fluoxetine group. In cases of the patients taking other antidepressants, 6 weeks of each medication was administered after 7 days of drug excretion period. The evaluation was done using 17 item HAM-D, MADRS, Clinical Global Impression Scale (CGI), and COVI scale after baseline, 1 week, 2 weeks, 4 weeks, and 6 weeks. The side effects that had occurred during the period of our study were put in records by developed/disappeared time, severities, incidences, managements and results. RESULTS: A total of 87 patients were enrolled. 70 (milnacipran group 39;fluoxetine group 31) of them were included for the 6 weeks of research and 17 of them dropped out within the first week, not due to adverse reactions or deficiency of effects. Total 17 item HAM-D scores, total points of MADRS, and CGI showed significant decrease after 1 week in each treatment group and continued decrease after 2 weeks and 4, 6 weeks. But there was no difference between milnacipran group and fluoxetine group in the antidepressant effect. There were no significant changes in vital sign, CBC, chemistry, and EKG in each treatment group. The commonly reported side effects of minlacipran were nausea (25.0%), headache (10.7%), vomiting (7.1%), constipation (7.1%), dizziness (7.1%) and those of fluoxetine were GI trouble (11.1%), diarrhea (11.1%), insomnia (11.1%), agitation (5.6%), and dizziness (5.6%). CONCLUSION: Milnacipran was effective for the improvement of depressive symptoms and was well tolerated and safe in patients with depression.
