F32
Conditions
Interventions
Group 1: Examination of patients with episodes of major depression, who are intended for a therapy with the antidepressant Valdoxan® according to the indication.
This includes for example:
- Patient
Sponsors
Servier Deutschland GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: patients with episodes of major depression, who are intended for a therapy with the antidepressant Valdoxan® according to the indication.
Exclusion criteria
Exclusion criteria: - contraindications to SmPC - patients under 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective of this non-interventional study (NIS) is to analyze application and tolerability of Valdoxan® in compliance with the summary of product characteristics, as well as the effect of treatment on depressive symptoms, in particular improvement of anhedonia as one of the key symptoms of depression and social functioning of patients with episodes of major depression under routine conditions at psychiatric centers. The following questions shall be analyzed: - Knowledge regarding application of Valdoxan® in the daily practice routine a:Change of depressive symptoms during treatment with Valdoxan® (Clinical Global Impression scale (CGI); at all 4 visits (U1-U4)) b:Influence of treatment on patients' social functioning (Sheehan Disability Scale (SDS); at all 4 visits (U1-U4)) c:Influence of treatment on patients' symptoms on anhedonia (Snaith Hamilton Pleasure Scale (SHAPS); at all 4 visits (U1-U4)) - Compliance with SmPC and package leaflet (standardized documentation of dosage regimen of Valdoxan®, as well as co-medication and concomitant diseases; at all 4 visits (U1-U4)) - Achieving knowledge regarding general tolerability (standardized ADR/AE forms and standardized documentation of reasons for study termination; at 3 visits (U2-U4)) - Insights regarding unknown adverse drug reactions/adverse events (ADRs/AEs) of agomelatine or events leading to discontinuation of study medication (standardized ADR/AE forms and standardized documentation of reasons for study termination; at 3 visits (U2-U4)) - Adding knowledge regarding known ADRs/AEs under routine application conditions leading to discontinuation of study medication (standardized ADR/AE forms and standardized documentation of reasons for study termination, Laboratory parameters (liver transaminases); at 3 visits (U2-U4)) | — |
Countries
Germany
Contacts
Public ContactBettina Barthel
Servier Deutschland GmbH
Outcome results
None listed