Clinical effectiveness of nemifitide, a novel pentapeptide antidepressant, in depressed outpatients: comparison of follow-up re-treatment with initial treatment
| Autor: | Gabriela Nicolau, John P. Feighner, Abajian Henry B, Joseph J. Hlavka, George Tonelli, Jeffrey S. Freed, Lev Sverdlov |
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| Rok vydání: | 2003 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Pentapeptide repeat Double-Blind Method Recurrence Internal medicine medicine Humans Initial treatment Pharmacology (medical) Psychiatry Adverse effect Psychiatric Status Rating Scales Pharmacology Depressive Disorder Major Dose-Response Relationship Drug business.industry medicine.disease Antidepressive Agents Clinical trial Psychiatry and Mental health Regimen Nemifitide Major depressive disorder Antidepressant Female business Oligopeptides Follow-Up Studies |
| Zdroj: | The International Journal of Neuropsychopharmacology. 6:207-213 |
| ISSN: | 1469-5111 1461-1457 |
| DOI: | 10.1017/s1461145703003481 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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