J Korean Neuropsychiatr Assoc.  2004 Jul;43(4):415-424.

The Efficacy and Safety of Milnacipran in Patients with Major Depression: A comparison with Fluoxetine

Affiliations
  • 1Department of Psychiatry, College of Medicine, Korea University, Seoul, Korea. leeminso@Korea.ac.kr
  • 2Department of Psychiatry, College of Medicine, Hallym University, Seoul, Korea.
  • 3Department of Psychiatry, College of Medicine, Chung-ang University, Seoul, Korea.
  • 4Department of Psychiatry, Keimyung University School of Medicine and Institute for Medical Science, Daegu, Korea.
  • 5Department of Psychiatry, Kangbuk Samsung Hospital, School of Medicine, Sungkyunkwan University, Seoul, Korea.
  • 6Department of Psychiatry, College of Medicine, Yonsei University, Seoul, Korea.
  • 7Department of Psychiatry, College of Medicine, Catholic University of Korea, Seoul, Korea.
  • 8Department of Psychiatry, College of Medicine, SoonChunHyang University, Seoul, Korea.
  • 9Department of Psychiatry, College of Medicine, Chungnam National University, Daejon, Korea.
  • 10Department of Psychiatry, Dong-A University College of Medicine, Busan, Korea.

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.

Keyword

Milnacipran; Fluoxetine; Efficacy; Safety

MeSH Terms

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
Antidepressive Agents
Dihydroergotamine
Fluoxetine
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