VIVALDI Praxis: Valdoxan improves depressive symptoms and normalizes circadian rhythms

VIVALDI Praxis: Valdoxan improves depressive symptoms and normalizes circadian rhythms: A prospective multicentre observational study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN18801971

Enrollment

3600

Registered

2010-04-22

Start date

2010-01-13

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 Recurrent depressive disorder

Interventions

Data on Valdoxan therapy for the treatment of major depression in daily routine practice will be collected from general practitioners, internists and their patients over a 3 month period.

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 information on Valdoxan therapy under daily routine practice by general practitioners and internists: 1.1. Changes in depressive symptoms under daily routine conditions via a short term version of the MADRS (Montgomery-Asberg Depression Rating Scale) and CGI (Clinical Global Impressions) questionnaire. 1.2. Effects of the therapy on quality of life and satisfaction of patients via patients-questionnaire (Q-LES-Q-SF) 1.3. Effects of the therapy on circadian rhythms via patients-questionnaire (questions 1, 2 and 5 of CircScreen) 2. Get information about how Valdoxan SmPC and patients' information are followed via standardized 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 standardized adverse drug reactions documentation and laboratory parameter (liver function testing) Outcomes will be measured at baseline, after approx. 2 weeks, after approx. 6 weeks and after approx.12 weeks.	—

Measure

Time frame

1. Get information on Valdoxan therapy under daily routine practice by general practitioners and internists: 1.1. Changes in depressive symptoms under daily routine conditions via a short term version of the MADRS (Montgomery-Asberg Depression Rating Scale) and CGI (Clinical Global Impressions) questionnaire. 1.2. Effects of the therapy on quality of life and satisfaction of patients via patients-questionnaire (Q-LES-Q-SF) 1.3. Effects of the therapy on circadian rhythms via patients-questionnaire (questions 1, 2 and 5 of CircScreen) 2. Get information about how Valdoxan SmPC and patients' information are followed via standardized 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 standardized adverse drug reactions documentation and laboratory parameter (liver function testing) Outcomes will be measured at baseline, after approx. 2 weeks, after approx. 6 weeks and after approx.12 weeks.

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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