Initiation of agomelatine after antidepressant treatment in outpatients suffering major depressive disorder

• Conditions: Major Depressive Disorder; MedDRA version: 14.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2010-019556-44-PT
• Lead Sponsor: Institut de Recherches Internationales Servier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-30
• Last Update Posted: 5 November 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 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 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