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Completed

NCT Number: NCT03555136

Real-life Effectiveness of Vortioxetine in Depression

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chokka Center For Integrative Health (CA0001), Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vortioxetine

Drug

Treatment with vortioxetine as per local SmPC

Primary outcomes

  1. Sheehan Disability Scale (SDS)

    Time frame: Change since baseline at week 12 and 24

    A series of patient self-rated, scales designed to measure the extent to which his or her 1) work or school, 2) social life or leisure activities, and 3) home life or family responsibilities are impaired by his or her symptoms

Secondary outcomes

  1. The Patient Health Questionnaire - nine items (PHQ-9)

    Time frame: Change since baseline at week 12 and 24

    A patient-rated scale designed to assess depression based on the nine DSM-IV criteria for depression

  2. Perceived Deficits Questionnaire - Depression - five items (PDQ-D-5)

    Time frame: Change since baseline at week 12 and 24

    A self-reported rating scale that aims to assess perceived cognitive deficits from the patient's perspective

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study title

Real-life Effectiveness of Vortioxetine in Patients With Major Depressive Disorder: Non-interventional, Multi-national, Prospective Cohort Study to Assess Real-life Effectiveness of Vortioxetine

Acronym: RELIEVE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 13, 2018
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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