Real-life effectiveness of vortioxetine on goal achievement and work productivity for patients with major depressive disorder in Japa

Phase 4

Recruiting

• Conditions: Major depressive disorder

• Registration Number: JPRN-jRCT1031210200
• Lead Sponsor: Hongo Seiji

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

The patient is an outpatient, treated in a general practitioner or psychiatric outpatient practice
- The patient has a diagnosis of major depressive episode according to the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSMV) (F32.x and F33.x)
- The patient is initiating treatment with vortioxetine according to the local Japanese label

Exclusion Criteria

- The patient is concurrently participating in a clinical trial
- The patient has a diagnosis of schizophrenia or other psychotic disorder according to DSM-V
- The patient has a diagnosis of bipolar disorder according to DSM-V
- The patient has a substance use disorders other than tobacco use disorder
- The patient has dementia or other neurodegenerative diseases significantly impacting cognitive functioning
- The patient has a mood disorder due to a general medical condition or substances

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- To assess the effectiveness of vortioxetine on goal achievement in patients with major depressive disorder (MDD) among working population in the context of routine clinical practice<br>- To evaluate changes in work productivity over 24 weeks in patients receiving vortioxetine

Secondary Outcome Measures

Name	Time	Method
- To assess the effectiveness of vortioxetine on depression severity, cognitive symptoms, emotional and overall functioning<br>- To assess the relationship between depression severity, cognitive symptoms, functioning, work productivity, and goal attainment<br>- To assess the patient segment or characteristics who benefit from vortioxetine treatment, predicted by the baseline demographic, symptomatic, functional and work environmental indices as well as past depression episodes and treatments.<br>- To describe vortioxetine treatment continuation rate at each visit time point<br>- To conduct psychometric validation of the Japanese version of Goal Attainment Scaling for Depression (GAS-D) scale<br>- To conduct psychometric validation of the Japanese version of Oxford Depression Questionnaire (ODQ) scale