The International Journal of Neuropsychopharmacology

Table of Contents - 2003 - Volume 6, Issue 03  


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

John P. Feighner a1, Lev Sverdlov a1c1, Gabriela Nicolau a1, Henry B. Abajian a1, Joseph Hlavka a1, Jeffrey S. Freed a1 and George Tonelli Jr. a1
a1 Innapharma, Inc., Park Ridge, NJ, USA

Article author query
feighner j   [PubMed][Google Scholar] 
sverdlov l   [PubMed][Google Scholar] 
nicolau g   [PubMed][Google Scholar] 
abajian h   [PubMed][Google Scholar] 
hlavka j   [PubMed][Google Scholar] 
freed j   [PubMed][Google Scholar] 
tonelli, jr. g   [PubMed][Google Scholar] 

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.

(Received August 11 2002)
(Reviewed December 11 2002)
(Revised February 3 2003)
(Accepted February 9 2003)


Key Words: Antidepressant; clinical effectiveness; nemifitide; peptides.

Correspondence:
c1 Dr L. Sverdlov, Innapharma, Inc., 1 Maynard Drive, Suite 205, Park Ridge, New Jersey 07656, USA. Tel.: 201-505-1300 (ext. 645) Fax: 201-505-1501 E-mail: LSVERDLOV@AOL.COM

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