VIVALDI Praxis: Valdoxan improves depressive symptoms and normalizes circadian rhythms

ISRCTN	ISRCTN18801971
DOI	https://doi.org/10.1186/ISRCTN18801971
Protocol serial number	IC4-20098-92-DEU
Sponsor	Servier Deutschland GmbH (Germany)
Funder	Servier Deutschland GmbH (Germany)

Submission date: 11/03/2010
Registration date: 22/04/2010
Last edited: 07/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Martin Kühn
Scientific

Elsenheimer Str. 53
Munich
80687
Germany

Phone	+49 (0)89 57095308
Email	martin.kuehn@de.netgrs.com

Study information

Primary study design	Observational
Study design	Observational prospective multicentre study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	VIVALDI Praxis: Valdoxan improves depressive symptoms and normalizes circadian rhythms: A prospective multicentre observational study
Study acronym	VIVALDI Praxis
Study objectives	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(s)	Freiburger Ethics Committee International (Mozartstr. 21, 79104 Freiburg [Germany] - Prof. Hans-Peter Graf, MD, PhD) approved on 26/10/2009 (feki code: 09/2435)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/09/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	3600
Key inclusion criteria	Adult patients with episodes of major depression
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	13/01/2010
Date of final enrolment	30/09/2010

Locations

Countries of recruitment

Germany

Study participating centre

Elsenheimer Str. 53

Munich
80687
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/06/2015	07/01/2021	Yes	No
Results article	results	01/04/2017	07/01/2021	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

07/01/2021: Publication references added.
13/09/2019: The publication and dissemination plan was added.