Clinical effectiveness of nemifitide, a novel pentapeptide antidepressant, in depressed outpatients: comparison of follow-up re-treatment with initial treatment

• Published in: The international journal of neuropsychopharmacology Vol. 6; no. 3; pp. 207 - 213
• Main Authors: Feighner, John P., Sverdlov, Lev, Nicolau, Gabriela, Abajian, Henry B., Hlavka, Joseph, Freed, Jeffrey S., Tonelli, George
• Format: Journal Article
• Language: English
• Published: Cambridge, UK Cambridge University Press 01.09.2003; Oxford University Press
• Subjects: Adolescent; Adult; Antidepressive Agents - administration & dosage; Antidepressive Agents - adverse effects; Antidepressive Agents - therapeutic use; Depressive Disorder, Major - drug therapy; Depressive Disorder, Major - psychology; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Oligopeptides - administration & dosage; Oligopeptides - adverse effects; Oligopeptides - therapeutic use; Psychiatric Status Rating Scales; Recurrence; Antidepressant; clinical effectiveness; peptides; nemifitide
• ISSN: 1461-1457; 1469-5111
• DOI: 10.1017/S1461145703003481

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.