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

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

Status

Recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1031210200

Enrollment

120

Registered

2021-07-15

Start date

2021-07-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive disorder

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
- 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 - To evaluate changes in work productivity over 24 weeks in patients receiving vortioxetine	—

Secondary

Measure	Time frame
- To assess the effectiveness of vortioxetine on depression severity, cognitive symptoms, emotional and overall functioning - To assess the relationship between depression severity, cognitive symptoms, functioning, work productivity, and goal attainment - 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. - To describe vortioxetine treatment continuation rate at each visit time point - To conduct psychometric validation of the Japanese version of Goal Attainment Scaling for Depression (GAS-D) scale - To conduct psychometric validation of the Japanese version of Oxford Depression Questionnaire (ODQ) scale	—

Measure

Time frame

- To assess the effectiveness of vortioxetine on depression severity, cognitive symptoms, emotional and overall functioning - To assess the relationship between depression severity, cognitive symptoms, functioning, work productivity, and goal attainment - 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. - To describe vortioxetine treatment continuation rate at each visit time point - To conduct psychometric validation of the Japanese version of Goal Attainment Scaling for Depression (GAS-D) scale - To conduct psychometric validation of the Japanese version of Oxford Depression Questionnaire (ODQ) scale

—

Contacts

Public ContactYoshiya Mogiguchi

Lundbeck Japan

yomo@lundbeck.com+81-70-1368-9261

Outcome results