Efficacy and safety of 30 mg/d and 45 mg/d nemifitide compared to placebo in major depressive disorder

Content Provider	Scilit
Author	Montgomery, Stuart A. Feighner, John P. Sverdlov, Lev Shrivastava, Ram K. Cunningham, Lynn A. Kiev, Ari Hlavka, Joseph Tonelli, Jr. George
Copyright Year	2005
Description	Nemifitide is a novel pentapeptide antidepressant, which appears to be effective in the treatment of major depressive disorder (MDD). In the present study 81 patients with MDD, DSM-IV criteria were randomized following a 1-wk screening period to receive 30 mg/d nemifitide, 45 mg/d nemifitide or placebo in a 6-wk double-blind, multicentre, outpatient efficacy study. Nemifitide or placebo was delivered by subcutaneous injection for 2 wk daily for 5 days (Monday to Friday) in the first 2 wk and patients were followed up for a further 4 wk. The primary efficacy measure was the change from baseline on the Montgomery–Asberg Depression Rating Scale. Secondary measures included the 17-item Hamilton Psychiatric Rating Scale for Depression (HAMD), the CGI severity and improvement scale and the Carroll Self-Rating Scale for Depression. This proof-of-principle study demonstrated a statistically significant superiority of the 45-mg/d dose vs. placebo at the time-point of peak effect (1 wk after the end of treatment). There appeared to be a greater effect with the 45 mg/d nemifitide dose than with 30 mg/d. An additional exploratory analysis by stratification of all patients by severity above and below or equal to the median baseline HAMD score of 22 showed a higher percentage of responders for both doses of nemifitide with statistical separation from placebo for patients with baseline HAMD score of >22 (above the median). There was no significant difference among treatment groups for patients with baseline HAMD score of ⩽22. Nemifitide showed a good tolerability and safety profile. There were no dropouts due to adverse events, and the incidence of side-effects with nemifitide was comparable with that of placebo.
Related Links	https://academic.oup.com/ijnp/article-pdf/9/5/517/2251433/9-5-517.pdf
Ending Page	528
Page Count	12
Starting Page	517
DOI	10.1017/s1461145705006139
Journal	International Journal of Neuropsychopharmacology
Issue Number	5
Volume Number	9
Language	English
Publisher	Cambridge University Press (CUP)
Publisher Date	2005-10-31
Access Restriction	Open
Subject Keyword	International Journal of Neuropsychopharmacology Psychiatry and Mental Health Clinical Psychology
Content Type	Text
Resource Type	Article