Effects of agomelatine on emotional experiences in depressed adults patients as compared to escitalopram
- Conditions
- Major Depressive DisorderMedDRA version: 14.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS System Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2011-005320-17-GB
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 398
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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;<br> Primary end point(s): No primary criterion has been defined for this exploratory study. The following criteria will be assessed:<br> - Emotional experiences<br> - Positive and negative affects (relative pattern of improvement)<br> - Return of pleasure<br> - Antidepressant efficacy<br> - Safety criteria<br> - Personality traits<br> ;Timepoint(s) of evaluation of this end point: All over the study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA