Dr Martin Kühn
Elsenheimer Str. 53
+49 (0)89 57095308
VIVALDI Praxis: Valdoxan improves depressive symptoms and normalizes circadian rhythms: A prospective multicentre observational study
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
Freiburger Ethics Committee International (Mozartstr. 21, 79104 Freiburg [Germany] - Prof. Hans-Peter Graf, MD, PhD) approved on 26/10/2009 (feki code: 09/2435)
Observational prospective multicentre study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Episodes of major depression
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.
Primary outcome measure
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
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
Adult patients with episodes of major depression
Target number of participants
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Elsenheimer Str. 53
Servier Deutschland GmbH (Germany)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
2011 results presented at DGPPN Kongress 2011 (Laux, G. and C. Steinmann. Antidepressive Behandlung mit Agomelatin in der Hausarztpraxis: Ergebnisse der Studie VIVALDI-Praxis, in DGPPN Kongress. 2011. Berlin. P-011 008).
2012 results presented at DGPPN Kongress 2012 (Laux G, S.C., Escafit-Schülke ML., Behandlung der Depression mit Agomelatin durch den Hausarzt: Ergebnisse der Studie VIVALDI Praxis, in 118. DGIM Kongress. 2012: Wiesbaden. PS139).
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)