Major Depressive Disorder Clinical Trial
— RELIEVEOfficial 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
NCT number | NCT03555136 |
Other study ID # | 17354N |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 17, 2017 |
Est. completion date | January 31, 2021 |
Verified date | May 2021 |
Source | H. Lundbeck A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S |
United States, Canada, France, Italy,
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 |
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