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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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7 October 2019 |
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Main ID: |
ISRCTN20363887 |
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Date of registration:
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19/06/2012 |
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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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Valdoxan ImproVes depRession with anxiEty symptoms (VIVRE)
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Scientific title:
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Valdoxan ImproVes depRession with anxiEty symptoms: a non-interventional study |
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Date of first enrolment:
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23/04/2012 |
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Target sample size:
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3000 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN20363887 |
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Study type:
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Observational |
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Study design:
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Observational non-interventional prospective multicentre study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Germany
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Martin
Kühn |
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Address:
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Servier Deutschland GmbH
Elsenheimer Str. 53
80687
Munich
Germany |
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Telephone:
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+49 89 57095 308 |
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Email:
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martin.kuehn@de.netgrs.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Adult patients with episodes of major depression according to the SmPC
Exclusion criteria: Does not meet inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Episodes of major depression
Mental and Behavioural Disorders
Recurrent depressive disorder, current episode severe
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Intervention(s)
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Observational period: 3 months, where the following will be documented:
1. Course of depressive symptoms (CGI, adapted version of CGI for patients)
2. Evolution of social and emotional functioning (SDS)
3. Evolution of anxiety symptoms within depression (COVI)
4. Adverse drug reactions
5. Liver function tests, if tested
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Primary Outcome(s)
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Obtain information on Valdoxan therapy under daily routine practice by psychiatrists:
1. Changes in depressive symptoms under daily conditions via CGI (Clinical Global impression) and anxiety symptoms within depression via COVI-scale
2. Effects of the treatment on depressive symptoms via patients' questionnaire (adapted CGI) and emotional and social functioning via SDS (Sheehan disability scale)
3. Get information about how Valdoxan SmPC and patients information are followed via standardized documentation of the dosage of Valdoxan, of comedicatins and concomittant diseases
4. Analysis of the general tolerability of Valdoxan under routine conditions via standardized adverse drug reactions' documentation and standardized documentation of therapy discontinuation
5. Analysis of unknown adverse drug reactions via standardized documentation
6. Get further information on known adverse drug reactions under routine practice in comorbide and comedicated patients via standardized adverse drug reactions' documentation and laboratory parameters (liver function testing)
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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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IC4-20098-128-DEU
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Source(s) of Monetary Support
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Servier Deutschland GmbH (Germany)
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Ethics review
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Status:
Approval date:
Contact:
Freiburger International Ethics Committee, 13/02/2012, ref: 012/1098
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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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31/01/2013 |
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URL:
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