Condition category
Mental and Behavioural Disorders
Date applied
13/01/2011
Date assigned
25/03/2011
Last edited
05/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martin Kühn

ORCID ID

Contact details

Elsenheimer Str. 53
Munich
80687
Germany
+49 (0)89 570 9530 8
martin.kuehn@de.netgrs.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IC4-20098-93-DEU

Study information

Scientific title

VITAL Germany (Valdoxan® improves treatment of depression and daytime activity in real life) : an observational prospective multicentre study

Acronym

VITAL Germany

Study hypothesis

Effects of Valdoxan® therapy on depressive symptoms, daytime well-being and compliance in adult patients with episodes of major depression under daily routine in an observational prospective multicentre trial by psychiatrists and general practitioners.

Ethics approval

Freiburger Ethics Committee International approved on 25/10/2010 (ref: 010/2141)

Study design

Observational prospective multicentre study

Primary study design

Observational

Secondary study design

Multi-centre

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Episodes of major depression

Intervention

1. Get information on Valdoxan® therapy under daily routine practice by psychiatrists and general practitioners:
1.1. Changes in depressive symptoms under daily routine conditions via CGI (Clinical Global Impressions)
1.2. Effects of the therapy on depressive symptoms and daytime well-being via patients-questionnaire Beck Depression Inventory (BDI-II) and Circ-Screen questions 5 and 6
1.3. Compliance via standardised questions to the patients
2. Get information about how Valdoxan® SmPC and patients information are followed via standardised documentation of the dosage of Valdoxan®, of comedications and concomittant diseases
3. Analysis of the general tolerability of Valdoxan® under routine conditions via standardised adverse drug reactions' documentation and standardised documentation of therapy discontinuation
4. Analysis of unknown adverse drug reactions via standardised documentation
5. Get further information on known adverse drug reactions under routine practice via standardised adverse drug reactions' documentation and laboratory parameter (liver function testing)

Study duration is about 6 months.

Intervention type

Drug

Phase

Not Applicable

Drug names

Valdoxan®

Primary outcome measures

1. Get informations on Valdoxan® therapy under daily routine practice by psychiatrists and general practitioners:
1.1. Changes in depressive symptoms under daily routine conditions via CGI (Clinical Global Impressions): measured at U0 (inclusion), U2 (after 2 weeks), U3 (after 6 weeks), U4 (after 12 weeks) and U5 (after 24 weeks)
1.2. Effects of the therapy on depressive symptoms and daytime well-being via patient-questionnaire Beck Depression Inventory (BDI-II) and Circ-Screen questions 5 and 6: measured at U0 (inclusion), U2 (after 2 weeks), U4 (after 12 weeks) and U5 (after 24 weeks)
1.3. Compliance via standardised questions to the patients: measured at U0 (inclusion), U2 (after 2 weeks), U4 (after 12 weeks) and U5 (after 24 weeks)
2. Get information about how Valdoxan® SmPC and patients information are followed via standardised documentation of the dosage of Valdoxan® and of comedications (measured at U0 [inclusion], U2 [after 2 weeks], U3 [after 6 weeks], U4 [after 12 weeks] and U5 [after 24 weeks]) and concomitant diseases (measured at U0 [inclusion])
3. Analysis of the general tolerability of Valdoxan® under routine conditions via standardised adverse drug reactions' documentation and standardised documentation of therapy discontinuation: measured at U2 (after 2 weeks), U3 (after 6 weeks), U4 (after 12 weeks) and U5 (after 24 weeks)
4. Analysis of unknown adverse drug reactions via standardised documentation: measured at U2 (after 2 weeks), U3 (after 6 weeks), U4 (after 12 weeks) and U5 (after 24 weeks)
5. Get further information on known adverse drug reactions under routine practice via standardised adverse drug reactions´documentation and laboratory parameter (liver function testing): measured at U2 (after 2 weeks), U3 (after 6 weeks), U4 (after 12 weeks) and U5 (after 24 weeks)

Secondary outcome measures

No secondary outcome measures

Overall trial start date

13/01/2011

Overall trial end date

31/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients with episodes of major depression

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4200 patients

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

13/01/2011

Recruitment end date

31/03/2012

Locations

Countries of recruitment

Germany

Trial participating centre

Elsenheimer Str. 53
Munich
80687
Germany

Sponsor information

Organisation

Servier Deutschland GmbH (Germany)

Sponsor details

Elsenheimer Str. 53
Munich
80687
Germany
+49 (0)89 570 9501
marie-laure.escafit-schuelke@de.netgrs.com

Sponsor type

Industry

Website

http://www.servier.com/

Funders

Funder type

Industry

Funder name

Servier Deutschland GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes