title: Double-blind, placebo-controlled study of INN 00835 (netamiftide) in the treatment of outpatients with major depression.
abstract: This study was designed to determine the safety, efficacy and pharmacokinetics of the antidepressant netamiftide (previously designated name: INN 00835) 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 days with drug, 11 for 5 days with drug followed by 5 days with placebo and 22 for 10 days with placebo only. The effect of treatment with netamiftide was evaluated by the following psychometric tests: Hamilton Depression Rating, Montgomery-Asberg Depression Rating Scale, Carroll Self-Rating Depression and Clinical Global Impression scales. None of the patients experienced significant adverse effects. A pharmacodynamic correlation (P < 0.05) was found between plasma drug concentrations and response to treatment. Highest plasma concentrations (Cmax) of netamiftide averaging 45.7 ng/ml were observed at 0.25 h after dosing. There were 89% responders in the group with Cmax > or = 45.7 ng/ml (minimum therapeutic concentration) versus 40% in the group with Cmax < 45.7 ng/ml. Onset of action was observed 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 with an excellent safety profile.
authors.affiliation: Innapharma Inc., Park Ridge, NJ 07656, USA.
authors.forename: J P
authors.initials: JP
authors.lastname: Feighner
authors.forename: R H
authors.initials: RH
authors.lastname: Ehrensing
authors.forename: A J
authors.initials: AJ
authors.lastname: Kastin
authors.forename: A
authors.initials: A
authors.lastname: Patel
authors.forename: L
authors.initials: L
authors.lastname: Sverdlov
authors.forename: J
authors.initials: J
authors.lastname: Hlavka
authors.forename: H B
authors.initials: HB
authors.lastname: Abajian
authors.forename: J F
authors.initials: JF
authors.lastname: Noble
authors.forename: G
authors.initials: G
authors.lastname: Nicolau
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D003866:Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009842:Oligopeptides / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D010045:Outpatients; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales
chemical_list: D000928:Antidepressive Agents; D009842:Oligopeptides; C406668:nemifitide ditriflutate