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

Observational cohort study to evaluate the safety of agomelatine in standard medical practice in depressed patients: a prospective, observational (non interventional), international, multicentre cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN53570733
Enrollment
10000
Registered
2010-08-27
Start date
2009-12-22
Completion date
Unknown
Last updated
2020-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive disorder Mental and Behavioural Disorders Depressive episode

Interventions

Please note that this is a non-interventional study
the objective is to evaluate in standard medical practice the safety of agomelatine prescribed to depressed patients. Dosage: Agomelatine 25 mg tablets - according to the SmPC, 25 mg

Sponsors

Institut de Recherches Internationales Servier (France)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Safety of agomelatine prescribed to depressed patients, measured each time patients will come and visit his/her physician. Please note that participation of patients in the agomelatine cohort will not trigger additional medical follow-up visits. The participating physician will follow patients through control visits planned as part of normal clinical practice.

Secondary

MeasureTime frame
No secondary outcome measures

Countries

France, Germany, Italy, Netherlands, Portugal, Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026