Valdoxan ImproVes depRession with anxiEty symptoms (VIVRE)

Valdoxan ImproVes depRession with anxiEty symptoms: a non-interventional study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN20363887

Enrollment

3000

Registered

2012-06-19

Start date

2012-04-23

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 Recurrent depressive disorder, current episode severe

Interventions

Observational period: 3 months, where the following will be documented: 1. Course of depressive symptoms (CGI, adapted version of CGI for patients) 2. Evolution of soci

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients with episodes of major depression according to the SmPC

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
Obtain information on Valdoxan therapy under daily routine practice by psychiatrists: 1. Changes in depressive symptoms under daily conditions via CGI (Clinical Global impression) and anxiety symptoms within depression via COVI-scale 2. Effects of the treatment on depressive symptoms via patients' questionnaire (adapted CGI) and emotional and social functioning via SDS (Sheehan disability scale) 3. Get information about how Valdoxan SmPC and patients information are followed via standardized documentation of the dosage of Valdoxan, of comedicatins and concomittant diseases 4. Analysis of the general tolerability of Valdoxan under routine conditions via standardized adverse drug reactions' documentation and standardized documentation of therapy discontinuation 5. Analysis of unknown adverse drug reactions via standardized documentation 6. Get further information on known adverse drug reactions under routine practice in comorbide and comedicated patients via standardized adverse drug reactions' documentation and laboratory parameters (liver function testing)	—

Measure

Time frame

Obtain information on Valdoxan therapy under daily routine practice by psychiatrists: 1. Changes in depressive symptoms under daily conditions via CGI (Clinical Global impression) and anxiety symptoms within depression via COVI-scale 2. Effects of the treatment on depressive symptoms via patients' questionnaire (adapted CGI) and emotional and social functioning via SDS (Sheehan disability scale) 3. Get information about how Valdoxan SmPC and patients information are followed via standardized documentation of the dosage of Valdoxan, of comedicatins and concomittant diseases 4. Analysis of the general tolerability of Valdoxan under routine conditions via standardized adverse drug reactions' documentation and standardized documentation of therapy discontinuation 5. Analysis of unknown adverse drug reactions via standardized documentation 6. Get further information on known adverse drug reactions under routine practice in comorbide and comedicated patients via standardized adverse drug reactions' documentation and laboratory parameters (liver function testing)

—

Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Germany

Outcome results

None listed

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