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 |
| Protocol serial number | CLE-20098-068 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- 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
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Scientific
Centre hospitalier Sainte Anne
Clinique des Maladies Mentales et de lEncéphale
100, rue de la santé
Paris
75014
France
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational (non-interventional) international multicentre cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 Applicable |
| Drug / device / biological / vaccine name(s) | Agomelatine |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 12/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 10000 |
| Total final enrolment | 1484 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 22/12/2009 |
| Date of final enrolment | 31/08/2014 |
Locations
Countries of recruitment
- France
- Germany
- Italy
- Netherlands
- Portugal
- Spain
Study participating centre
75014
France
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The 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 |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
