Condition category
Mental and Behavioural Disorders
Date applied
11/03/2010
Date assigned
22/04/2010
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 57095308
martin.kuehn@de.netgrs.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IC4-20098-92-DEU

Study information

Scientific title

VIVALDI Praxis: Valdoxan improves depressive symptoms and normalizes circadian rhythms: A prospective multicentre observational study

Acronym

VIVALDI Praxis

Study hypothesis

Effects of Valdoxan therapy on depressive symptoms and circadian rhythm dysfunction in adult patients with episodes of major depression under daily routine in an observational prospective multicentre trial by general practitioners and internists

Ethics approval

Freiburger Ethics Committee International (Mozartstr. 21, 79104 Freiburg [Germany] - Prof. Hans-Peter Graf, MD, PhD) approved on 26/10/2009 (feki code: 09/2435)

Study design

Observational prospective multicentre study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

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

Data on Valdoxan therapy for the treatment of major depression in daily routine practice will be collected from general practitioners, internists and their patients over a 3 month period.

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

1. Get information on Valdoxan therapy under daily routine practice by general practitioners and internists:
1.1. Changes in depressive symptoms under daily routine conditions via a short term version of the MADRS (Montgomery-Asberg Depression Rating Scale) and CGI (Clinical Global Impressions) questionnaire.
1.2. Effects of the therapy on quality of life and satisfaction of patients via patients-questionnaire (Q-LES-Q-SF)
1.3. Effects of the therapy on circadian rhythms via patients-questionnaire (questions 1, 2 and 5 of CircScreen)
2. Get information about how Valdoxan SmPC and patients' information are followed via standardized documentation of the dosage of Valdoxan, of comedications and concomitant 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 standardized adverse drug reactions documentation and laboratory parameter (liver function testing)

Outcomes will be measured at baseline, after approx. 2 weeks, after approx. 6 weeks and after approx.12 weeks.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

13/01/2010

Overall trial end date

30/09/2010

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

3600 patients

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

13/01/2010

Recruitment end date

30/09/2010

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 5709501
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