A double-blind, placebo-controlled, efficacy, safety, and pharmacokinetic study of INN 00835, a novel antidepressant peptide, in the treatment of major depression
| Autor: | H. Abajian, Abba J. Kastin, R.H Ehrensing, J. Hlavka, L. Sverdlov, Brian E. Leonard, J.P. Feighner, G. Nicolau, A. Patel, J.F. Noble |
|---|---|
| Rok vydání: | 2000 |
| Předmět: |
Adult
Male Serotonin Population Placebo Severity of Illness Index Double-Blind Method Pharmacokinetics Hamd Humans Medicine Dosing education Retrospective Studies Psychiatric Status Rating Scales Depressive Disorder Major education.field_of_study business.industry Middle Aged Antidepressive Agents Psychiatry and Mental health Clinical Psychology Treatment Outcome Pharmacodynamics Anesthesia Antidepressant Female business Oligopeptides Biomarkers Follow-Up Studies Blood sampling |
| Zdroj: | Journal of Affective Disorders. 61:119-126 |
| ISSN: | 0165-0327 |
| DOI: | 10.1016/s0165-0327(99)00187-1 |
| Popis: | Background: INN 00835 is a synthetic pentapeptide with a potential for rapid onset of action as an antidepressant. Its efficacy was investigated in a pilot study in patients diagnosed with major depression. Methods: Fifty two patients received either active drug — INN 00835 (26 patients) — or placebo (26 patients), subcutaneously at 0.2 mg/kg for 5 consecutive days. The patients were evaluated for an additional 4 weeks after treatment. Efficacy was evaluated by the following psychiatric rating scales: HAMD, MADRS, CSRS, CGI, and VAS. The effect of treatment was also evaluated by using a biochemical marker: changes in blood platelet serotonin (5HT) uptake rates in drug-treated patients compared to those in the placebo group. Plasma concentrations of INN 00835 were measured by LC/MS. Results: Statistical analysis indicated a strong pharmacodynamic correlation between plasma drug concentrations at 1 h after dosing and the reduction in the severity of depression as measured by the psychiatric rating scales. A minimum effective plasma concentration (MEC) of INN 00835 was 5 ng/ml. Statistically significant differences in response to treatment (P |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Full Text from ScienceDirect