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Pharmacopsychiatry 2005; 38(1): 30-35
DOI: 10.1055/s-2005-837769
Original Paper
© Georg Thieme Verlag KG Stuttgart · New York

A Comparative Study of the Efficacy and Safety Profiles Between Fluvoxamine and Nortriptyline in Japanese Patients with Major Depression

T. Otsubo1 , Y. Akimoto1 , H. Yamada1 , R. Koda1 , H. Aoyama1 , K. Tanaka2 , M. Mimura1 , K. Nakagome1 , K. Kamijima1
  • 1Department of Psychiatry, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8566, Japan
  • 2Department of Occupational Mental, Graduate School of Medical Sciences, Kitasato University, 1-15-1 Kitasato Sagami-shi, Kanagawa 228-8555, Japan
Further Information

Publication History

Received: 22.10.2003 Revised: 23.12.2003

Accepted: 5.7.2004

Publication Date:
11 February 2005 (online)

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Objective: The aim of this study was to compare the efficacy and safety profiles between fluvoxamine and nortriptyline in Japanese patients with major depression. Methods: The efficacy and safety profiles of fluvoxamine, a selective serotonin-reuptake inhibitor, and nortriptyline were compared under a single-blind fashion in 74 Japanese patients with major depression. The efficacy was assessed using the 17-item Hamilton Rating Scale for Depression (HAM-D), Clinical Global Impression Scale (CGI) severity and improvement scores, while the safety profiles were assessed using the UKU Side Effect Rating Scale at baseline, and on days 7, 14, 28 and 56. Moreover, with the aim of determining the distinct efficacy profiles of each drug, the effects on each of the factor scores extracted by the principal component analysis performed for HAM-D scores were compared between drugs. Results: Both drug groups showed significant amelioration of depressive symptomatology over the trial period lasting for 8 weeks. Statistical analyses revealed no significant between-group differences regarding the efficacy assessed by either HAM-D or CGI scores; however, the efficacy of nortriptyline tended to appear earlier than that of fluvoxamine. Moreover, no significant differences were obtained for the factor scores, representing ‘depressed mood’, ‘physical symptoms’ or ‘sleep disturbances’, although ‘sleep disturbances’ appeared to improve earlier in the nortriptyline group than in the fluvoxamine group. As for the safety profiles, the nortriptyline group scored a significantly higher incidence of adverse events such as dysarthria or orthostatic dizziness, as well as increased heart rate. Conclusions: These findings suggest that fluvoxamine is generally comparable to nortriptyline in its efficacy and superior in its safety profile, in accordance with findings obtained in previous comparative clinical trials conducted in Caucasian populations.

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Kazuyuki Nakagome

Department of Psychiatry

School of Medicine

Showa University

1-5-8, Hatanodai, Shinagawa-ku

Tokyo 142-8666

Japan

Phone: +81-3-3784-8703

Phone: +81-3-3784-8569

Fax: +81-3-3784-8354

Email: nakagome@med.showa-u.ac.jp

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