Comparison of Agomelatine (25 mg/day, adjustement to 50 mg/day) with Escitalopram (10mg/day, adjustement to 20 mg/day) on general interest in outpatients with Major Depressive Disorder over 12 weeks of treatment

Phase 1

Conditions: Major Depressive Disorder
MedDRA version: 19.0Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2010-023576-10-RO

Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Male or female outpatients
- Aged between 18 and 65 years (inclusive) at the time of selection
- Fulfilling DSM-IV-TR criteria for current Major Depressive Episode (MDE) < = 12
months, of moderate to severe intensity
- Major Depressive Episode diagnosis documented using the brief structured interview M.I.N.I.
- QIDS-SR16 item 13 (General interest) > = 2
- HAM-D-17 total score > = 22
- CGI-S (Severity of illness) > = 4 (moderately to severely ill)
- Requiring an antidepressant treatment
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patient fulfilling DSM-IV-TR criteria for a MDE of mild intensity or severe episode with psychotic features, catatonic features or with duration < 4 weeks
- All types of depression other than MDD, according to DSM-IV-TR criteria
- Marked suicidal intent and/or known suicidal tendencies for the current episode defined as a score of 4 at the item 3 of the HAM-D-17 and/or in the investigator's opinion based on the patient's medical history, previous suicide attemps, quality of social and familial support
- Pregnancy, breastfeeding or possibility of becoming pregnant during the study and without an effective contraception.
- Hepatic impairment and severe renal insufficiency
Patients with known QT interval prolongation or congenital long QT syndrome.
For patients with stable cardiac disease: any clinically relevant abnormality detected during the ECG likely to interfere with the study conduct or evaluations

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the early effect of agomelatine on general interest in outpatient suffering from Major Depressive Disorder<br>;Secondary Objective: To describe/assess effects on the concentration/decision making, energy level, daytime sleepiness, severity of depression, global clinical benefit, social functioning, emotional experiences, and to provide additional safety and tolerability data on agomelatine.;Primary end point(s): General interest score obtained from the VAS reflecting the item 13 of the QIDS-SR 16 scale.;Timepoint(s) of evaluation of this end point: W1

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: all over the trial;Secondary end point(s): Secondary objectives:<br>The secondary objectives are to compare agomelatine and escitalopram’s effects on the:<br>- Concentration/decision making <br>- Energy level<br>- Daytime sleepiness <br>- Severity of depression <br>- Global clinical benefit <br>- Social functioning <br>- Emotional experiences<br>and to provide additional safety and tolerability data on agomelatine.<br>