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

ISRCTN	ISRCTN44890666
DOI	https://doi.org/10.1186/ISRCTN44890666
Protocol serial number	IC4-20098-93-DEU
Sponsor	Servier Deutschland GmbH (Germany)
Funder	Servier Deutschland GmbH (Germany)

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

Primary study design	Observational
Study design	Observational prospective multicentre study
Secondary study design	Multi-centre
Study type	Participant 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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Valdoxan®
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	4200
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

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	04/08/2016	13/09/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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