VIVALDI: Valdoxan® improves depressive symptoms and normalises circadian rhythms

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN49411996

Enrollment

8000

Registered

2009-05-15

Start date

2009-03-16

Completion date

Unknown

Last updated

2019-02-11

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 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-A

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Does not meet inclusion criteria

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
No secondary outcome measures	—

Countries

Germany

Outcome results

None listed

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