title: Clinical effectiveness of nemifitide, a novel pentapeptide antidepressant, in depressed outpatients: comparison of follow-up re-treatment with initial treatment.
abstract: Data from two Phase 2 clinical studies with nemifitide, a novel pentapeptide antidepressant, were evaluated. The initial double-blind, placebo-controlled study was performed on outpatients with DSM-IV criteria for major depressive disorder. An open-label extension study enrolled subjects either completing or having been discontinued due to lack of efficacy during the follow-up period of the initial study. In the extension study, both the investigator and the subjects were blinded to the previous treatment in the initial study. No clinically significant side-effects were observed in either study. Twenty-seven subjects have been entered and evaluated in the extension study. Eighteen of these 27 subjects (66.7%) responded to re-treatment in the extension study. Mean duration of effect between re-treatments was 3.3 months. The results of the extension study support investigating a range of doses of nemifitide from 18 to 72 mg/d in future clinical trials. Further studies are planned to determine the most effective nemifitide clinical treatment regimen.
authors.affiliation: Innapharma, Inc., Park Ridge, NJ 07656, USA.
authors.forename: John P
authors.initials: JP
authors.lastname: Feighner
authors.forename: Lev
authors.initials: L
authors.lastname: Sverdlov
authors.forename: Gabriela
authors.initials: G
authors.lastname: Nicolau
authors.forename: Henry B
authors.initials: HB
authors.lastname: Abajian
authors.forename: Joseph
authors.initials: J
authors.lastname: Hlavka
authors.forename: Jeffrey S
authors.initials: JS
authors.lastname: Freed
authors.forename: George
authors.initials: G
authors.lastname: Tonelli
mesh_terms: D000293:Adolescent; D000328:Adult; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D009842:Oligopeptides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D012008:Recurrence
chemical_list: D000928:Antidepressive Agents; D009842:Oligopeptides; C406668:nemifitide ditriflutate