Condition category
Mental and Behavioural Disorders
Date applied
06/04/2010
Date assigned
27/08/2010
Last edited
05/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Frédéric Rouillon

ORCID ID

Contact details

Centre hospitalier Sainte Anne
Clinique des Maladies Mentales et de l’Encéphale
100
rue de la santé
Paris
75014
France

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CLE-20098-068

Study information

Scientific title

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

Acronym

Study hypothesis

To evaluate in standard medical practice the safety of agomelatine prescribed to depressed patients.

Ethics approval

First Ethics Committee approval obtained on 09/11/2009

Study design

Prospective observational (non-interventional) international multicentre cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Major depressive disorder

Intervention

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 once daily taken orally at bedtime (up to 50 mg once daily if no improvement of symptoms after 2 weeks of treatment).

Duration: patients followed during a maximum of 28 weeks.

Intervention type

Drug

Phase

Not Specified

Drug names

Agomelatine

Primary outcome measures

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 outcome measures

No secondary outcome measures

Overall trial start date

22/12/2009

Overall trial end date

01/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10,000 (agomelatine cohort)

Participant 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

Recruitment start date

22/12/2009

Recruitment end date

01/12/2012

Locations

Countries of recruitment

France, Germany, Italy, Netherlands, Portugal, Spain

Trial participating centre

Centre hospitalier Sainte Anne
Paris
75014
France

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Institut de Recherches Internationales Servier (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes