Condition category
Mental and Behavioural Disorders
Date applied
26/02/2009
Date assigned
15/05/2009
Last edited
08/11/2013
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 8957095308
martin.kuehn@de.netgrs.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IC4-20098-63-DEU

Study information

Scientific title

VIVALDI: Valdoxan® improves depressive symptoms and normalises circadian rhythms - an observational prospective 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

The Freiburger Ethics Commission International (feci), approved on 19/12/2008 (ref: 08/2694)

Study design

Observational prospective longitudinal multi-centre study

Primary study design

Observational

Secondary study design

Multi-centre

Trial setting

Hospitals

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

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 names

Agomelatine (Valdoxan®)

Primary outcome measures

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 trial start date

16/03/2009

Overall trial end date

30/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, adult patients (>=18 years)
2. Episodes of major depression

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8,000 patients/max. 2,000 doctors

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

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 895709501
marie-laure.escafit-schuelke@de.netgrs.com

Sponsor type

Industry

Website

http://www.servier.de

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