Double-blind, placebo-controlled study of INN 00835 (netamiftide) in the treatment of outpatients with major depression.
Int Clin Psychopharmacol
; 16(6): 345-52, 2001 Nov.
Article
en En
| MEDLINE
| ID: mdl-11712623
ABSTRACT
This study was designed to determine the safety, efficacy and pharmacokinetics of the antidepressant netamiftide (previously designated name INN 00835) after 5 or 10 daily doses administered to patients diagnosed with major depression. Netamiftide was administered subcutaneously at a fixed dose of 18 mg/patient per day. Of the 55 enrolled patients, 22 were dosed for 10 days with drug, 11 for 5 days with drug followed by 5 days with placebo and 22 for 10 days with placebo only. The effect of treatment with netamiftide was evaluated by the following psychometric tests Hamilton Depression Rating, Montgomery-Asberg Depression Rating Scale, Carroll Self-Rating Depression and Clinical Global Impression scales. None of the patients experienced significant adverse effects. A pharmacodynamic correlation (P < 0.05) was found between plasma drug concentrations and response to treatment. Highest plasma concentrations (Cmax) of netamiftide averaging 45.7 ng/ml were observed at 0.25 h after dosing. There were 89% responders in the group with Cmax > or = 45.7 ng/ml (minimum therapeutic concentration) versus 40% in the group with Cmax < 45.7 ng/ml. Onset of action was observed within 48 h after treatment, peak effect was observed at approximately 1 week after treatment and efficacy lasted during a 4-week follow-up period. Netamiftide is a promising antidepressant with rapid onset of action and with an excellent safety profile.
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Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Oligopéptidos
/
Trastorno Depresivo
/
Antidepresivos
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
/
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Int Clin Psychopharmacol
Asunto de la revista:
PSICOFARMACOLOGIA
Año:
2001
Tipo del documento:
Article
País de afiliación:
Estados Unidos