Effects of agomelatine on emotional experiences in depressed adults patients as compared to escitalopram

Effects of agomelatine versus escitalopram on emotional experiences in outpatients suffering from Major Depressive Disorder. An exploratory, randomised, double-blind, international, multicentre study with parallel groups: agomelatine (25 to 50 mg/day) versus escitalopram (10 to 20 mg/day) over a 6- month period.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005320-17-GB

Enrollment

500

Registered

2012-03-07

Start date

2012-06-13

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Major Depressive Disorder MedDRA version: 14.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: VALDOXAN Product Name: S20098 Product Code: S20098 Pharmaceutical Form: Capsule INN or Proposed INN: AGOMELATINE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Outpatients aged between 18 (or minimum legal age) and 65 years (inclusive), fluent in English, i.e. competent in reading, writing and speaking English (except for Brazil, fluent in Portuguese) - Fulfilling DSM-IV criteria for Major Depressive Disorder, single episode or recurrent (maximum 3 episodes including the current one) documented using the brief structured interview M.I.N.I. 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 475 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25

Exclusion criteria

Exclusion criteria: - Depressive episode of mild intensity according to DSM-IV TR criteria - Marked suicidal intent and/or known suicidal tendencies for the current episode - Women of childbearing potential without effective contraception method - Pregnant or breast-feeding women - Patients not able to read or to complete self-rating questionnaires - All types of depression other than Major Depressive Disorder, all other psychiatric disorders

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this exploratory study is to differentiate the effect of two antidepressants, agomelatine versus escitalopram, on the emotional experiences in outpatients suffering from Major Depressive Disorder.;Secondary Objective: NA; Primary end point(s): No primary criterion has been defined for this exploratory study. The following criteria will be assessed: - Emotional experiences - Positive and negative affects (relative pattern of improvement) - Return of pleasure - Antidepressant efficacy - Safety criteria - Personality traits ;Timepoint(s) of evaluation of this end point: All over the study	—

Measure

Time frame

Main Objective: The purpose of this exploratory study is to differentiate the effect of two antidepressants, agomelatine versus escitalopram, on the emotional experiences in outpatients suffering from Major Depressive Disorder.;Secondary Objective: NA; Primary end point(s): No primary criterion has been defined for this exploratory study. The following criteria will be assessed: - Emotional experiences - Positive and negative affects (relative pattern of improvement) - Return of pleasure - Antidepressant efficacy - Safety criteria - Personality traits ;Timepoint(s) of evaluation of this end point: All over the study

—

Secondary

Measure	Time frame
Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA	—

Countries

Australia, Brazil, Canada, Singapore, South Africa, United Kingdom

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com+33 1 55 72 43 66

Outcome results

None listed

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