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

VITAL Germany (Valdoxan® improves treatment of depression and daytime activity in real life) : an observational prospective multicentre study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN44890666

Enrollment

4200

Registered

2011-03-25

Start date

2011-01-13

Completion date

Unknown

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Episodes of major depression Mental and Behavioural Disorders Depressive episode

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients with episodes of major depression

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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

Measure	Time frame
No secondary outcome measures	—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026