VIVALDI: Valdoxan® improves depressive symptoms and normalises circadian rhythms

ISRCTN	ISRCTN49411996
DOI	https://doi.org/10.1186/ISRCTN49411996
Secondary identifying numbers	IC4-20098-63-DEU

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

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

Study design	Observational prospective longitudinal multi-centre study
Primary study design	Observational
Secondary study design	Multi-centre
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	VIVALDI: Valdoxan® improves depressive symptoms and normalises circadian rhythms - an observational prospective study
Study acronym	VIVALDI
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 multi-centre trial.
Ethics approval(s)	The Freiburger Ethics Commission International (feci), approved on 19/12/2008 (ref: 08/2694)
Condition	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
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Agomelatine (Valdoxan®)
Primary outcome measure	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.
Secondary outcome measures	No secondary outcome measures
Overall study start date	16/03/2009
Overall study end date	30/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	8,000 patients/max. 2,000 doctors
Participant inclusion criteria	1. Both males and females, adult patients (>=18 years) 2. Episodes of major depression
Participant exclusion criteria	Does not meet inclusion criteria
Recruitment start date	16/03/2009
Recruitment end date	30/10/2010

Locations

Countries of recruitment

Germany

Study participating centre

Elsenheimer str. 53

Munich
80687
Germany

Sponsor information

Servier Deutschland GmbH (Germany)
Industry

Elsenheimer Str. 53
Munich
80687
Germany

Phone	+49 895709501
Email	marie-laure.escafit-schuelke@de.netgrs.com
Website	http://www.servier.de
"ROR"	https://ror.org/05wk4ae67

Funders

Funder type

Industry

Servier Deutschland GmbH (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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

Editorial Notes

18/01/2019: Publication reference added