Initiation of agomelatine after antidepressant treatment by SSRI or SNRI in outpatients suffering Major Depressive Disorder. A 3-week, randomised, double then single-blind, controlled, parallel groups, international, multicentre safety study with a 5-week open extension period. - ND

• Conditions: Major Depressive Disorder; MedDRA version: 9.1Level: LLTClassification code 10057840

• Registration Number: EUCTR2010-019556-44-IT
• Lead Sponsor: INSTITUT DE RECHERCHES INTERNATIONALES SERVIER

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

-Male or female outpatients, -Aged between 18 and 65 years, -Fulfilling DSM-IV TR criteria for Major Depressive Episode of moderate or severe intensity, -Diagnosis documented using the brief structured interview M.I.N.I., -Clinical Global Impression item 1: CGI severity of illness = 4 (= from moderately ill to extremely ill), -Hospital Anxiety and Depression scale (HAD) completed, -Treated with either paroxetine or venlafaxine at therapeutic doses continuously for at least 6 weeks, -Requiring a change in antidepressant treatment due to an insufficient treatment efficacy with or without acceptability problems.
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

-Patient fulfilling DSM-IV-TR criteria for a Major Depressive Episode of mild intensity and/or episode with psychotic features, catatonic features or with duration < 6 weeks, -All types of mood disorder other than Major Depressive Disorder, according to DSM-IV TR criteria, -Patient treated within 2 weeks before selection visit with either paroxetine or venlafaxine, but in association with another antidepressant drug for more than 3 days, -High Suicidality” according to MINI 5.0.0., -Marked suicidal intent and/or suicidal risk for the current episode, according to the investigator`s opinion, -Women of childbearing potential without effective contraception, -Pregnant or breast-feeding women, -Patients treated within the 4 weeks before selection visit with either an antipsychotic or a barbiturate, - Patients treated with a depot antipsychotic within 2 injection-period time before selection visit, -Patient treated within the 2 weeks before selection visit with a benzodiazepine at a dose which is superior to the maximum recommended dosage, -Hepatic impairment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified