Real-life Effectiveness of Vortioxetine in Depression (RELIEVE)

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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Vortioxetine

• Study Type: Observational
• Enrollment (Actual): 992

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G2J0C4
    • Alpha Recherche Clinique (CA0017)
  • Alberta
    • Edmonton, Alberta, Canada, T6L 6W6
      • Chokka Center For Integrative Health (CA0001)
  • Ontario
    • Chatham, Ontario, Canada, N7L 1C1
      • Chatham-Kent Clinical Trials Research Centre (CA0007)
    • Kingston, Ontario, Canada, K7L 2Y6
      • Queen's University-Hotel Dieu Hospital (CA0011)
    • London, Ontario, Canada, N6C0A7
      • St. Joseph's Health Care London - Parkwood Institute (Regional Mental Health Care London and Parkwood Hospital) (CA0004)
    • Toronto, Ontario, Canada, M4W 2N4
      • Start Clinic For Mood And Anxiety Disorders (CA0006)
    • Toronto, Ontario, Canada, M5G 1N8
      • Jodha Tishon Inc (CA0008)
  • Quebec
    • Montreal, Quebec, Canada, H1M 1B1
      • GCP Research (CA0013)
    • Point Claire, Quebec, Canada, H9R4S3
      • Mana Research Inc (CA0012)
    • Quebec City, Quebec, Canada, G3K 2P8
      • Alpha Recherche Clinique (CA0009)
• France
  • Angers, France, 49000
    • Dr. Philippe Remaud MD, Office of (FR0010)
  • Angers Cedex, France, 49033
    • Chru Houtel Dieu (FR0020)
  • Angouleme, France, 16000
    • Clinique Villa Bleue (FR0008)
  • Argenteuil, France, 95100
    • Clinique Clinea orgemont (FR0061)
  • Blois, France, 41016
    • Centre Hospitalier De Blois (FR0011)
  • Chalezeule, France, 25220
    • CH De Novillars (FR0025)
  • Clermont Ferrand Cedex 1, France, 63000
    • CHU Clermont-Ferrand, Hopital Gabriel Montpied (FR0037)
  • Dury, France, 80480
    • Chs Philippe Pinel (Fr0017)
  • Elancourt, France, 78990
    • Centre Medical Ambroise Pare (FR0005)
  • Grenoble cedex 9, France, 38043
    • Hopital Albert Michallon- CHU Grenoble Alpes (FR0021)
  • La Crau, France, 83260
    • Clinique Korian La Crau (FR0063)
  • Lamagistere, France, 82360
    • Dr. Norbert Rigaud Md, Office Of (FR0028)
  • Limoges, France, 87025
    • Centre Hospitalier Esquirol (FR0038)
  • Marseille, France, 13008
    • Clinique Mon Repos (FR0057)
  • Martigues Cedex, France, 13500
    • Centre Hospitalier De Martigues (FR0064)
  • Montpellier Cedex, France, 34295
    • Hopital de la Colombiere (FR0026)
  • Mulhouse, France, 68100
    • Cabinet Medical (FR0043)
  • Nancy, France, 54037
    • Maison Des Addictions (FR0006)
  • Nice, France, 06002
    • Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur - Clinique de Psychiatrie et de Psychologie Medicale (FR0041)
  • Nimes, France, 30090
    • Centre Hospitalier Universitaire de Nimes (FR0018)
  • Paris, France, 75014
    • Centre Hospitalier Sainte Anne (FR0029)
  • Quimper, France, 29000
    • Camp Antonin Artaud (FR0001)
  • Rueil-Malmaison, France, 92500
    • Dr. Dominique Januel, MD Office of (FR0044)
  • St Denis, France, 93200
    • Unites De Soins Romain Rolland (FR0012)
  • St Priest En Jarez Cedex, France, 42277
    • Hopital Nord (FR0042)
  • Strasbourg, France, 67000
    • Dr Lousqui Charles MD, Office of (FR0033)
  • Strasbourg, France, 67901
    • Hopital civil (FR0039)
  • Thouars, France, 79100
    • Cabinet Du Dr D Bonneau (FR0036)
  • Toulon, France, 83000
    • Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer - Hôpital Sainte Musse (FR0019)
  • Toulouse, France, 31059
    • Hopital De Psychiatrie (FR0009)
  • Toulouse, France, 31200
    • Dr. David Modavi Md, Office Of (FR0034)
  • Toulouse, France, 31200
    • Dr. Joel Pon MD, Office of (FR0027)
  • Alsace
    • Rouffach, Alsace, France, 68250
      • Centre Hospitalier Bp29 (FR0015)
    • Strasbourg, Alsace, France, 67000
      • Dr Philippe Marmor, MD, Office of (FR0035)
  • Cedex
    • Bron Cedex, Cedex, France, 69678
      • CHS Le Vinatier (FR0013)
  • Cedex 1
    • Nantes, Cedex 1, France, 44000
      • CHU de Nantes (FR0023)
  • Yvelines
    • Le Vesinet, Yvelines, France, 78110
      • Cmpi (FR0004)
• Italy
  • Bergamo, Italy, 24127
    • ASST Papa Giovanni XXIII (IT0016)
  • Brescia, Italy, 25123
    • Università degli Studi di Brescia (IT0029)
  • Catania, Italy, 95125
    • Universita Degli Studi Di Catania - Azienda Policlinico (IT0030)
  • Catanzaro, Italy, 88100
    • Universita Degli Studi Magna Graecia Di Catanzaro (IT0006)
  • Cosenza, Italy, 87100
    • DSM Cosenza (IT0015)
  • Cremona, Italy, 26100
    • Psichiatria Ospedale Oglio Po (IT0023)
  • Foggia, Italy, 71100
    • Ospedali Riuniti Foggia (IT0007)
  • Lecce, Italy, 73100
    • Dipartimento Salute Mentale ASL Lecce (IT0009)
  • Lodi, Italy, 20100
    • ASST Lodi (IT0042)
  • Massa, Italy, 54100
    • Azienda Toscana nord ovest zona Apuane (IT0039)
  • Messina, Italy, 98125
    • Policlinico Universitario Di Messina (IT0031)
  • Milano, Italy, 20142
    • Azienda Ospedaliera San Paolo - Universita Degli Studi Di Milano (IT0014)
  • Milano, Italy, 20157
    • Disturbi Depressivi Ospedale Luigi Sacco Polo Universitario Psichiatria 2 - CTDD (IT0033)
  • Monza, Italy, 20900
    • Pneumology Clinic - AO San Gerardo (IT0017)
  • Roma, Italy, 00185
    • Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma (IT0032)
  • Roma, Italy, 45
    • Villa Von Siebenthal (IT0008)
  • Rome, Italy, 00168
    • Universita Cattolica del Sacro Cuore (University of Sacred Heart Policlinico A. Gemelli) (IT0018)
  • Terracina, Italy, 04019
    • Ospedale Alfredo Fiorini (IT0026)
  • Turin, Italy, 10126
    • University Of Turin (IT0001)
  • LU
    • Lucca, LU, Italy, 55043
      • Ospedale Versilia (IT0002)
  • Milano
    • Albese con Cassano, Milano, Italy, 22032
      • Casa di Cura Villa San Benedetto Menni, Suore Ospedaliere (IT0025)
  • Roma
    • Colleferro, Roma, Italy, 34
      • Asl Roma G (IT0005)
    • Rome, Roma, Italy, 00189
      • Ospedale Sant'Andrea Hospital (IT0003)
  • Rome
    • Roma, Rome, Italy, 00163
      • Insituto Di Ricovero E Cura A Carattere Scientifico San Raffaele Pisana (IT0035)
  • Teramo
    • Giulianova, Teramo, Italy, 64021
      • DSM Giulianova - ospedale di Giulianova (IT0019)
  • Torino
    • Orbassano, Torino, Italy, 10043
      • Azienda Ospedaliero-Universitaria San Luigi Gonzaga (IT0004)
  • Toscana
    • Firenze, Toscana, Italy, 50100
      • Istituto di Neuroscienze (INS) (IT0028)
  • Umbria
    • Perugia, Umbria, Italy, 06122
      • Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0034)
• United States
  • Alabama
    • Dothan, Alabama, United States, 36303
      • Harmonex Neuroscience Research Inc (US0072)
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Center For Advanced Improvement (US0011)
  • California
    • Newport Beach, California, United States, 92660
      • Pharmacology Research Institute (US0045)
    • Oceanside, California, United States, 92054
      • North County Clinical Research (Nccr) (US0071)
    • San Bernardino, California, United States, 92408
      • Breakthrough Clinical Trials (US0074)
    • Temecula, California, United States, 92591
      • Viking Clinical Research Center LLC (US0033)
  • Florida
    • Boca Raton, Florida, United States, 33487
      • Da Vinci Research Institute (US0063)
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials (US0066)
    • Hialeah, Florida, United States, 33018
      • Maxblue Institute (US0038)
    • Jacksonville, Florida, United States, 32256
      • Office Of Amit Vijapura, Md (US0057)
    • Miami, Florida, United States, 33183
      • International Research Associates LLC (US0060)
    • Orlando, Florida, United States, 32839
      • Millenia Psychiatry and Research, Inc. (US0015)
    • Saint Petersburg, Florida, United States, 33713
      • Professional Health Care of Pinellas (US0050)
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Northwest Behavioral Research Center (US0007)
  • Idaho
    • Ammon, Idaho, United States, 83406
      • Pearl Health Clinic (US0001)
  • Illinois
    • Glen Carbon, Illinois, United States, 62034
      • Southern Illinois Associates LLC (US0079)
    • Naperville, Illinois, United States, 60563
      • AMR- Baber Research, Inc. (US0006)
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University Of Kansas Cancer Center (US0078)
  • Maryland
    • Rockville, Maryland, United States, 20852
      • Neuroscientific Insights (US0029)
  • Michigan
    • Rochester Hills, Michigan, United States, 48307
      • Rochester Center For Behavioral Medicine (US0059)
  • Missouri
    • Saint Charles, Missouri, United States, 63304
      • St. Charles Psychiatric Associates - Midwest Research Group (US0039)
  • Nebraska
    • Lincoln, Nebraska, United States, 68526
      • Alivation Research, LLC (US0020)
    • Norfolk, Nebraska, United States, 68701
      • Meridian Clinical Research (US0027)
  • New York
    • Rochester, New York, United States, 14618
      • Finger Lakes Clinical Research (US0005)
  • Ohio
    • Avon Lake, Ohio, United States, 44012
      • Quest Therapeutics Of Avon Lake (US0002)
  • Tennessee
    • Franklin, Tennessee, United States, 37067
      • Psychiatric Consultants, Pc (US0028)
  • Texas
    • Friendswood, Texas, United States, 77546
      • Bay Pointe Behavioral Health (US0030)
    • Houston, Texas, United States, 77084
      • Biopharma Informatic, Llc
    • Houston, Texas, United States, 77084
      • Biopharma Informatic, LLC (US0031)
    • Richmond, Texas, United States, 77407
      • West park Springs (US0073)
  • Washington
    • Everett, Washington, United States, 98201
      • Core Clinical Research (US0067)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Outpatients from primary, secondary or tertiary care centres

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients initiating vortioxetine treatment; Patients with major depressive disorder initiating treatment with vortioxetine	Drug: Vortioxetine; Treatment with vortioxetine as per local SmPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sheehan Disability Scale (SDS)	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	Change since baseline at week 12 and 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Patient Health Questionnaire - nine items (PHQ-9)	A patient-rated scale designed to assess depression based on the nine DSM-IV criteria for depression	Change since baseline at week 12 and 24
Perceived Deficits Questionnaire - Depression - five items (PDQ-D-5)	A self-reported rating scale that aims to assess perceived cognitive deficits from the patient's perspective	Change since baseline at week 12 and 24

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact H. Lundbeck A/S, LundbeckClinicalTrials@Lundbeck.com

Publications and helpful links

General Publications

• Almeida SS, Christensen MC, Simonsen K, Adair M. Effectiveness of vortioxetine in patients with major depressive disorder and co-morbid generalized anxiety disorder in routine clinical practice: A subgroup analysis of the RELIEVE study. J Psychopharmacol. 2022 Nov 15:2698811221132468. doi: 10.1177/02698811221132468. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2017
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: June 1, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin Antagonists; Anti-Anxiety Agents; Serotonin 5-HT3 Receptor Antagonists; Vortioxetine
• Other Study ID Numbers: 17354N

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No