VITAL Germany (Valdoxan® Improves Treatment of depression and daytime Activity in real Life)

ISRCTN	ISRCTN44890666
DOI	https://doi.org/10.1186/ISRCTN44890666
Secondary identifying numbers	IC4-20098-93-DEU

Submission date: 13/01/2011
Registration date: 25/03/2011
Last edited: 13/09/2019

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 (0)89 570 9530 8
Email	martin.kuehn@de.netgrs.com

Study information

Study design	Observational prospective multicentre study
Primary study design	Observational
Secondary study design	Multi-centre
Study setting(s)	Other
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	VITAL Germany (Valdoxan® improves treatment of depression and daytime activity in real life) : an observational prospective multicentre study
Study acronym	VITAL Germany
Study objectives	Effects of Valdoxan® therapy on depressive symptoms, daytime well-being and compliance in adult patients with episodes of major depression under daily routine in an observational prospective multicentre trial by psychiatrists and general practitioners.
Ethics approval(s)	Freiburger Ethics Committee International approved on 25/10/2010 (ref: 010/2141)
Health condition(s) or problem(s) studied	Episodes of major depression
Intervention	1. Get information on Valdoxan® therapy under daily routine practice by psychiatrists and general practitioners: 1.1. Changes in depressive symptoms under daily routine conditions via CGI (Clinical Global Impressions) 1.2. Effects of the therapy on depressive symptoms and daytime well-being via patients-questionnaire Beck Depression Inventory (BDI-II) and Circ-Screen questions 5 and 6 1.3. Compliance via standardised questions to the patients 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 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 reactions' documentation and laboratory parameter (liver function testing) Study duration is about 6 months.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Valdoxan®
Primary outcome measure	1. Get informations on Valdoxan® therapy under daily routine practice by psychiatrists and general practitioners: 1.1. Changes in depressive symptoms under daily routine conditions via CGI (Clinical Global Impressions): measured at U0 (inclusion), U2 (after 2 weeks), U3 (after 6 weeks), U4 (after 12 weeks) and U5 (after 24 weeks) 1.2. Effects of the therapy on depressive symptoms and daytime well-being via patient-questionnaire Beck Depression Inventory (BDI-II) and Circ-Screen questions 5 and 6: measured at U0 (inclusion), U2 (after 2 weeks), U4 (after 12 weeks) and U5 (after 24 weeks) 1.3. Compliance via standardised questions to the patients: measured at U0 (inclusion), U2 (after 2 weeks), U4 (after 12 weeks) and U5 (after 24 weeks) 2. Get information about how Valdoxan® SmPC and patients information are followed via standardised documentation of the dosage of Valdoxan® and of comedications (measured at U0 [inclusion], U2 [after 2 weeks], U3 [after 6 weeks], U4 [after 12 weeks] and U5 [after 24 weeks]) and concomitant diseases (measured at U0 [inclusion]) 3. Analysis of the general tolerability of Valdoxan® under routine conditions via standardised adverse drug reactions' documentation and standardised documentation of therapy discontinuation: measured at U2 (after 2 weeks), U3 (after 6 weeks), U4 (after 12 weeks) and U5 (after 24 weeks) 4. Analysis of unknown adverse drug reactions via standardised documentation: measured at U2 (after 2 weeks), U3 (after 6 weeks), U4 (after 12 weeks) and U5 (after 24 weeks) 5. Get further information on known adverse drug reactions under routine practice via standardised adverse drug reactions´documentation and laboratory parameter (liver function testing): measured at U2 (after 2 weeks), U3 (after 6 weeks), U4 (after 12 weeks) and U5 (after 24 weeks)
Secondary outcome measures	No secondary outcome measures
Overall study start date	13/01/2011
Completion date	31/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	4200 patients
Total final enrolment	3005
Key inclusion criteria	Adult patients with episodes of major depression
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	13/01/2011
Date of final enrolment	31/03/2012

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 (0)89 570 9501
Email	marie-laure.escafit-schuelke@de.netgrs.com
Website	http://www.servier.com/
"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	04/08/2016	13/09/2019	Yes	No

Editorial Notes

13/09/2019: Publication reference and total final enrolment.