Jp. Feighner et al., Double-blind, placebo-controlled study of INN 00835 (netamiftide) in the treatment of outpatients with major depression, INT CLIN PS, 16(6), 2001, pp. 345-352
This study was designed to determine the safety, efficacy and pharmacokinet
ics of the antidepressant netamiftide (previously designated name: INN 0083
5) after 5 or 10 daily doses administered to patients diagnosed with major
depression. Netamiftide was administered subcutaneously at a fixed dose of
18 mg/patient per day. Of the 55 enrolled patients, 22 were dosed for 10 da
ys with drug, 11 for 5 days with drug followed by 5 days with placebo and 2
2 for 10 days with placebo only. The effect of treatment with netamiftide w
as evaluated by the following psychometric tests: Hamilton Depression Ratin
g, Montgomery-Asberg Depression Rating Scale, Carroll Self-Rating Depressio
n and Clinical Global Impression scales. None of the patients experienced s
ignificant adverse effects. A pharmacodynamic correlation (P < 0.05) was fo
und between plasma drug concentrations and response to treatment. Highest p
lasma concentrations (C-max) of netamiftide averaging 45.7 ng/ml were obser
ved at 0.25 h after dosing. There were 89% responders in the group with C-m
ax greater than or equal to 45.7 ng/ml (minimum therapeutic concentration)
versus 40% in the group with C-max < 45.7 ng/ml. Onset of action was observ
ed within 48 h after treatment, peak effect was observed at approximately 1
week after treatment and efficacy lasted during a 4-week follow-up period.
Netamiftide is a promising antidepressant with rapid onset of action and w
ith an excellent safety profile. (C) 2001 Lippincott Williams & Wilkins.