VIVALDI: Valdoxan® improves depressive symptoms and normalises circadian rhythms

ISRCTN	ISRCTN49411996
DOI	https://doi.org/10.1186/ISRCTN49411996
Protocol serial number	IC4-20098-63-DEU
Sponsor	Servier Deutschland GmbH (Germany)
Funder	Servier Deutschland GmbH (Germany)

Submission date: 26/02/2009
Registration date: 15/05/2009
Last edited: 18/01/2019

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 8957095308
Email	martin.kuehn@de.netgrs.com

Study information

Primary study design	Observational
Study design	Observational prospective longitudinal multi-centre study
Secondary study design	Multi-centre
Study type	Participant information sheet
Scientific title	VIVALDI: Valdoxan® improves depressive symptoms and normalises circadian rhythms - an observational prospective study
Study acronym	VIVALDI
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 multi-centre trial.
Ethics approval(s)	The Freiburger Ethics Commission International (feci), approved on 19/12/2008 (ref: 08/2694)
Health condition(s) or problem(s) studied	Episodes of major depression
Intervention	1. Get informations on Valdoxan® (oral) therapy under daily routine practice: 1.1. Changes in depressive symptoms under daily routine conditions via a short version of the Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impressions (CGI) questionnaire 1.2. Effects of the therapy on circadian rhythm dysfunction and sleep via CircScreen patients questionnaire 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 standardized documentation of therapy discontinuation 4. Analysis of unknown adverse drug reactions via standardized documentation 5. Get further information on known adverse drug reactions under routine practice via standardized adverse drug reaction documentation and laboratory parameter (liver function testing) Study duration: 3 months. Optional follow-up period of 9 months. There will be 4 assessment-visits in VIVALDI (duration approx. 3 months) and a total of 6 assessment visits for patients included in VIVALDI follow-up (further 9 months). Study duration = approx. 12 months for patients included in the follow-up. Visit 1 = inclusion visit Visit 2 = control visit (approx. 2 weeks after inclusion visit) Visit 3 = control visit (approx. 6 weeks after inclusion visit) Visit 4 = final visit (approx. 12 weeks after inclusion visit for patients who are not included in the follow-up) VIVALDI Follow-up (further 9 months): Visit 5 = first control visit of the follow-up (approx. 6 months after inclusion visit) Visit 6 = final visit of the follow-up (approx.12 months after inclusion visit) All primary outcome measures will be assessed at inclusion visit, visit 2, visit 3, visit 4, visit 5, visit 6.
Intervention type	Drug
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Agomelatine (Valdoxan®)
Primary outcome measure(s)	1. Get information on Valdoxan® therapy under daily routine practice: 1.1. Changes in depressive symptoms under daily routine conditions via a short version of the Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impressions (CGI) questionnaire 1.2. Effects of the therapy on circadian rhythm dysfunction and sleep via CircScreen patients questionnaire 2. Get information about how Valdoxan SmPC and patients information are followed via standardised 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 standardised adverse drug reaction documentation and laboratory parameter (liver function testing) All primary outcome measures will be assessed at inclusion visit, visit 2, visit 3, visit 4, visit 5, visit 6.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	8000
Key inclusion criteria	1. Both males and females, adult patients (>=18 years) 2. Episodes of major depression
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	16/03/2009
Date of final enrolment	30/10/2010

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	01/11/2012	18/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

18/01/2019: Publication reference added