Real-life Effectiveness of Vortioxetine in Depression

Major Depressive Disorder Clinical Trial

— RELIEVE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555136
• Other study ID #: 17354N
• Status: Completed
• Start date: November 17, 2017
• Est. completion date: January 31, 2021

Study information

• Verified date: May 2021
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 992
• Est. completion date: January 31, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Vortioxetine
Treatment with vortioxetine as per local SmPC

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

United States,  Canada,  France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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