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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004642-92-ES

Enrollment

400

Registered

2009-01-20

Start date

2009-04-01

Completion date

Unknown

Last updated

2012-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trastorno Depresivo Mayor//Major Depressive Disorder MedDRA version: 11.0 Level: LLT Classification code 10057840 Term:

Interventions

Product Name: S20098 Product Code: S20098 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: agomelatine CAS Number: 138112-76-2 Current Sponsor code: S20098 Concentration unit: mg milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Eficacia antidepresiva a largo plazo de agomelatina comparada con duloxetina//Long-term antidepressant efficacy of agomelatine compared to duloxetine.;Secondary Objective: Beneficio clínico global de agomelatina, efecto sobre los síntomas depresivos, patrones de sueño, funcionamiento socila y calidad de vida//Global clinical benefit of agomelatine, effect on depressive symptoms, sleep patterns, social functioning and quality of life. To provide additional safety and tolerability data on agomelatine.;Primary end point(s): HAM-D	—

Measure

Time frame

Main Objective: Eficacia antidepresiva a largo plazo de agomelatina comparada con duloxetina//Long-term antidepressant efficacy of agomelatine compared to duloxetine.;Secondary Objective: Beneficio clínico global de agomelatina, efecto sobre los síntomas depresivos, patrones de sueño, funcionamiento socila y calidad de vida//Global clinical benefit of agomelatine, effect on depressive symptoms, sleep patterns, social functioning and quality of life. To provide additional safety and tolerability data on agomelatine.;Primary end point(s): HAM-D

—

Countries

Hungary, Italy, Portugal, Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026