Real-life Effectiveness of Vortioxetine in Depression (RELIEVE)

Lundbeck

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Drug: Vortioxetine

Study type: Observational

Funder types: Industry

Identifiers

NCT03555136

17354N

Details and patient eligibility

About

Worldwide Major Depressive Disorder (MDD) has significant negative personal, societal and economic consequences.

Vortioxetine (Brintellix®) is a new antidepressant authorized since 2013. Despite evidence generated from clinical trials which demonstrate that vortioxetine is an efficacious, well-tolerated antidepressant, there is a need to determine the effectiveness of vortioxetine in real life routine practice.

The study aim is to examine the real-life effectiveness of vortioxetine on functioning, depressive symptom relief, cognition and quality of life.

This is an observational, multi-national, study in patients with MDD initiating treatment with vortioxetine. Information will be collected by the physician, from the patient and their medical record at three time points - baseline, week 12 and week 24 (end of follow-up). This study will be conducted in six countries. In total 2,100 patients are planned for enrolment.

Enrollment: 992 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The patient is ≥18 years
• The patient is an outpatient, treated in a GP or psychiatric outpatient practice
• The patient has a diagnosis of major depressive episode according to local diagnostic criteria
• The patient has been prescribed vortioxetine according to the local Summary of Product Characteristics (SmPC)

Exclusion criteria

• The patient is unable to read and understand the information sheet and informed consent form or the Patient Reported Outcomes (PRO)
• The patient is concurrently participating in a clinical trial
• The patient has a diagnosis of schizophrenia or other psychotic disorder according to local diagnostic criteria
• The patient has a diagnosis of bipolar disorder according to local diagnostic criteria
• The patient has a substance use disorders other than tobacco use disorder
• The patient has dementia or other neurodegenerative disease significantly impacting cognitive functioning
• The patient has a mood disorder due to a general medical condition or substances
• The patient is pregnant, ≤6 months post-partum or breastfeeding
• The patient is at significant risk of suicide in the investigator's opinion or the patient has attempted suicide within the last six months
• The patient is a member of the study personnel or of their immediate families, or is a subordinate (or immediate family member of a subordinate) to any of the study personnel

Trial design

992 participants in 1 patient group

Patients initiating vortioxetine treatment

Description:

Patients with major depressive disorder initiating treatment with vortioxetine

Treatment:

Drug: Vortioxetine