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

Phase 3

Completed

• Conditions: Major depressive disorder; Mental and Behavioural Disorders; Depressive episode

• Registration Number: ISRCTN97599615
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-10
• Study Completion: 2012-01-31
• Last Update Posted: 4 May 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 316

Inclusion Criteria

1. Aged between 18 and 65 years
2. Fulfilling Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV-TR) criteria for major depressive episode of moderate or severe intensity
3. Diagnosis documented using the brief structured interview Mini International Neuropsychiatric Interview (MINI)
4. Clinical Global Impression scale
5. Requiring a change in antidepressant treatment due to an insufficient treatment efficacy associated or not with poor acceptability

Exclusion Criteria

1. High suicidality according to MINI 5.0.0.
2. Marked suicidal intent and/or suicidal risk for the current episode, according to the investigator's opinion
3. Hepatic impairment

Study & Design

• Study Type: Interventional
• Study Design: Not specified