Citation

Murasaki M, Kamijima K, Yamauchi T, Miura S, Kariya T, Mori A, Hasegawa K, Toru M, Hirose T, Yamaguchi N, Asai M, Yamashita I, Endo S, Kitanishi K, Nomura S. Japanese Journal of Neuropsychopharmacology 1996; 18(3): 191-204.

Copyright

(Copyright © 1996)

DOI

unavailable

PMID

unavailable

Abstract

SME3110 was given to 74 patients with depression or depressive state in order to investigate it's efficacy and safety. SME3110 was administrated in the doses ranging from an initial dose of 50 mg/day to a maximum dose of 300 mg/day for 6 weeks, following a fixed flexible dosing design. As shown in changes of the scores on the Hamilton Depression Rating Scale and the CPRG Rating Scale, SME3110 excellently improved psychiatric symptoms including 'depressed mood,' 'suicide,' and 'psychic anxiety' and a suppressed volition or mood. Further, the drug had an effect on sleep disorder or physical symptoms such as 'decreased appetite.' The efficacy assessment revealed the improvement rate of 55.6% (40 of 72 patients). In the safety assessment, SME3110 was demonstrated to be highly safe, with the rate of 62.2% (46 of 74 patients) in patients with no safety problem. The most common adverse reaction was nausea. SME3110 produced a lower incidence of anticholinergic adverse reactions including dry mouth, constipation, and dizziness/vertigo. The usefulness assessment showed the usefulness rate of 52.7% (39 of 74 patients). Thus, SME3110 is concluded to exert excellent antidepressive effect and to be highly safe, with a lower incidence of anticholinergic adverse reactions.

Language: ja

Keywords

adult; human; aged; depression; clinical trial; antidepressant; article; major clinical study; fluvoxamine; serotonin uptake inhibitor; xerostomia; vertigo; constipation; drug safety; drug efficacy; drug receptor binding; nausea; drug effect; fluvoxamine maleate; dose response; SSRI; phase 2 clinical trial