Double-blind, placebo-controlled study of INN 00835 (netamiftide) in the treatment of outpatients with major depression

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.