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

ISRCTN ISRCTN53570733
DOI https://doi.org/10.1186/ISRCTN53570733
Secondary identifying numbers CLE-20098-068
Submission date
06/04/2010
Registration date
27/08/2010
Last edited
28/09/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Frédéric Rouillon
Scientific

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

Study information

Study designProspective observational (non-interventional) international multicentre cohort study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleObservational cohort study to evaluate the safety of agomelatine in standard medical practice in depressed patients: a prospective, observational (non interventional), international, multicentre cohort study
Study objectivesTo evaluate in standard medical practice the safety of agomelatine prescribed to depressed patients.
Ethics approval(s)First Ethics Committee approval obtained on 09/11/2009
Health condition(s) or problem(s) studiedMajor depressive disorder
InterventionPlease 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Agomelatine
Primary outcome measureSafety 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 measuresNo secondary outcome measures
Overall study start date13/10/2009
Completion date12/03/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants10,000 (agomelatine cohort)
Total final enrolment1484
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment22/12/2009
Date of final enrolment31/08/2014

Locations

Countries of recruitment

  • France
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • Spain

Study participating centre

Centre hospitalier Sainte Anne
Paris
75014
France

Sponsor information

Institut de Recherches Internationales Servier (France)
Industry

50 rue Carnot
Suresnes
92284
France

Website http://www.servier.com/
ROR logo "ROR" https://ror.org/034e7c066

Funders

Funder type

Industry

Institut de Recherches Internationales Servier (France)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planTo be confirmed at a later date
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2020 03/08/2020 Yes No
Results article results 01/01/2021 28/09/2020 Yes No

Editorial Notes

28/09/2020: Publication reference added.
03/08/2020: Publication reference and total final enrolment number added.
25/06/2020: No publications found.
12/10/2017: The following changes were made to the trial record:
1. The overall trial start date was changed from 22/12/2009 to 13/10/2009.
2. The overall trial end date was changed from 01/12/2012 to 12/03/2015.