Efficacy and safety of 30 mg/d and 45 mg/d nemifitide compared to placebo in major depressive disorder.
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 <or=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.
Montgomery
Stuart A
SA
Imperial College School of Medicine, London, UK.
Feighner
John P
JP
Sverdlov
Lev
L
Shrivastava
Ram K
RK
Cunningham
Lynn A
LA
Kiev
Ari
A
Hlavka
Joseph
J
Tonelli
George
G
D000328:Adult; D000704:Analysis of Variance; D000928:Antidepressive Agents / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D003865:Major Depressive Disorder / Q000188:drug therapy*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000627:therapeutic use*; D011594:Psychometrics; D012720:Severity of Illness Index; D012737:Sex Factors; D013997:Time Factors
D000928:Antidepressive Agents; D009842:Oligopeptides; C406668:nemifitide ditriflutate