Observational cohort study to evaluate the safety of agomelatine in standard medical practice in depressed patients

Not Applicable

Completed

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

• Registration Number: ISRCTN53570733
• Lead Sponsor: Institut de Recherches Internationales Servier (France)

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/32729068/ (added 03/08/2020) 2020 results in https://pubmed.ncbi.nlm.nih.gov/32976677/ (added 28/09/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-27
• Study Completion: 2015-03-12
• Last Update Posted: 12 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1484

Inclusion Criteria

1. Both genders patients aged at least 18 years or legal age of majority (without upper limit of age)
2. Initiated into agomelatine for their current depressive episode
3. Having signed an informed consent

Exclusion Criteria

1. Having to stop an ongoing antidepressant with which they were treated with success for their depression
2. Already treated with another antidepressant that they wish to continue in addition to agomelatine
3. Planning to move during the 26 weeks of the follow-up

Study & Design

• Study Type: Observational
• Study Design: Not specified