Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details 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
Pharmaceutical study type(s)
Phase
Not Applicable
Drug/device/biological/vaccine name(s)
Agomelatine
Primary outcome measure
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 study start date
13/10/2009
Overall study end date
12/03/2015
Reason abandoned (if study stopped)
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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
10,000 (agomelatine cohort)
Total final enrolment
1484
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
31/08/2014
Locations
Countries of recruitment
France, Germany, Italy, Netherlands, Portugal, Spain
Study 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
ROR
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
To be confirmed at a later date
Intention to publish date
Individual participant data (IPD) sharing plan
The data sharing plans for the current study are unknown and will be made available at a later date
IPD sharing plan summary
Data sharing statement to 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 |