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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 October 2020 |
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Main ID: |
ISRCTN53570733 |
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Date of registration:
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27/08/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Observational cohort study to evaluate the safety of agomelatine in standard medical practice in depressed patients
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Scientific title:
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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 |
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Date of first enrolment:
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22/12/2009 |
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Target sample size:
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10000 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN53570733 |
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Study type:
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Observational |
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Study design:
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Prospective observational (non-interventional) international multicentre cohort study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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France
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Germany
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Italy
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Netherlands
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Portugal
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Spain
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Contacts
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Name:
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Frédéric
Rouillon |
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Address:
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Centre hospitalier Sainte Anne
Clinique des Maladies Mentales et de l?Encéphale
100, rue de la santé
75014
Paris
France |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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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:
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Major depressive disorder
Mental and Behavioural Disorders
Depressive episode
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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No secondary outcome measures
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Secondary ID(s)
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CLE-20098-068
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Source(s) of Monetary Support
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Institut de Recherches Internationales Servier (France)
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Ethics review
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Status:
Approval date:
Contact:
First Ethics Committee approval obtained on 09/11/2009
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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12/03/2015 |
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URL:
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