Evaluación de la eficacia y el beneficio clínico de agomelatina (25 a 50 mg/día) durante un período de tratamiento de 6 meses en pacientes con Trastorno Depresivo Mayor.Estudio aleatorizado, doble ciego, internacional multicéntrico con grupos paralelos versus duloxetina (60 mg/día). Veinticuatro semanas de tratamiento.//Evaluation of efficacy and clinical benefit of agomelatine (25 to 50 mg/day) over a 6-month treatment period in patients with Major Depressive Disorder.A randomised, double-blind, international multicentre study with parallel groups versus duloxetine (60 mg/day).Twenty-four weeks of treatment.

aboratorios Servier S.L.0 sites400 target enrollmentJanuary 20, 2009

Overview

No summary available.

Registry

who.int

Start Date

January 20, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

aboratorios Servier S.L.

•Pacientes ambulatorios de ambos sexos\-edad entre 18 (o edad mínima legal) y 65 años (incluido)\-cumplir criterios de DSM\-IV para el Trastorno Depresivo Mayor//Out\-patients of both genders \- Aged between 18 (or minimum legal age) and 65 years (inclusive) \- fulfilling DSM\-IV criteria for Major Depressive Disorder.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•Mujeres en edad fértil sin tratamiento anticonceptivo eficaz\-Otros tipos de depresión distintos del MDD\-Cualquier anomalía relevante detectada durante el examen físico, ECG o pruebas de laboratorio que probablemente pueda interferir con el desarrollo del estudio y su evaluación//Women of childbearing potential without effective contraception, \- Other types of depression than MDD, \- Any clinically relevant abnormality detected during the physical examination, ECG or laboratory tests likely to interfere with the study conduct or evaluations.