Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
992 participants
OBSERVATIONAL
2017-11-17
2021-01-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients initiating vortioxetine treatment
Patients with major depressive disorder initiating treatment with vortioxetine
Vortioxetine
Treatment with vortioxetine as per local SmPC
Interventions
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Vortioxetine
Treatment with vortioxetine as per local SmPC
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Harmonex Neuroscience Research Inc (US0072)
Dothan, Alabama, United States
Center For Advanced Improvement (US0011)
Tucson, Arizona, United States
Pharmacology Research Institute (US0045)
Newport Beach, California, United States
North County Clinical Research (Nccr) (US0071)
Oceanside, California, United States
Breakthrough Clinical Trials (US0074)
San Bernardino, California, United States
Viking Clinical Research Center LLC (US0033)
Temecula, California, United States
Da Vinci Research Institute (US0063)
Boca Raton, Florida, United States
Sarkis Clinical Trials (US0066)
Gainesville, Florida, United States
Maxblue Institute (US0038)
Hialeah, Florida, United States
Office Of Amit Vijapura, Md (US0057)
Jacksonville, Florida, United States
International Research Associates LLC (US0060)
Miami, Florida, United States
Millenia Psychiatry and Research, Inc. (US0015)
Orlando, Florida, United States
Professional Health Care of Pinellas (US0050)
St. Petersburg, Florida, United States
Northwest Behavioral Research Center (US0007)
Marietta, Georgia, United States
Pearl Health Clinic (US0001)
Ammon, Idaho, United States
Southern Illinois Associates LLC (US0079)
Glen Carbon, Illinois, United States
AMR- Baber Research, Inc. (US0006)
Naperville, Illinois, United States
University Of Kansas Cancer Center (US0078)
Kansas City, Kansas, United States
Neuroscientific Insights (US0029)
Rockville, Maryland, United States
Rochester Center For Behavioral Medicine (US0059)
Rochester Hills, Michigan, United States
St. Charles Psychiatric Associates - Midwest Research Group (US0039)
Saint Charles, Missouri, United States
Alivation Research, LLC (US0020)
Lincoln, Nebraska, United States
Meridian Clinical Research (US0027)
Norfolk, Nebraska, United States
Finger Lakes Clinical Research (US0005)
Rochester, New York, United States
Quest Therapeutics Of Avon Lake (US0002)
Avon Lake, Ohio, United States
Psychiatric Consultants, Pc (US0028)
Franklin, Tennessee, United States
Bay Pointe Behavioral Health (US0030)
Friendswood, Texas, United States
Biopharma Informatic, LLC (US0031)
Houston, Texas, United States
Biopharma Informatic, LLC
Houston, Texas, United States
West park Springs (US0073)
Richmond, Texas, United States
Core Clinical Research (US0067)
Everett, Washington, United States
Chokka Center For Integrative Health (CA0001)
Edmonton, Alberta, Canada
Chatham-Kent Clinical Trials Research Centre (CA0007)
Chatham, Ontario, 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
Start Clinic For Mood And Anxiety Disorders (CA0006)
Toronto, Ontario, Canada
Jodha Tishon Inc (CA0008)
Toronto, Ontario, Canada
GCP Research (CA0013)
Montreal, Quebec, Canada
Mana Research Inc (CA0012)
Point Claire, Quebec, Canada
Alpha Recherche Clinique (CA0009)
Québec, Quebec, Canada
Alpha Recherche Clinique (CA0017)
Québec, , Canada
Centre Hospitalier Bp29 (FR0015)
Rouffach, Alsace, France
Dr Philippe Marmor, MD, Office of (FR0035)
Strasbourg, Alsace, France
CHU de Nantes (FR0023)
Nantes, Cedex 1, France
CHS Le Vinatier (FR0013)
Bron, Cedex, France
Cmpi (FR0004)
Le Vésinet, Yvelines, France
Dr. Philippe Remaud MD, Office of (FR0010)
Angers, , France
Chru Houtel Dieu (FR0020)
Angers, , France
Clinique Villa Bleue (FR0008)
Angoulême, , France
Clinique Clinea orgemont (FR0061)
Argenteuil, , France
Centre Hospitalier De Blois (FR0011)
Blois, , France
CH De Novillars (FR0025)
Chalezeule, , France
CHU Clermont-Ferrand, Hopital Gabriel Montpied (FR0037)
Clermont-Ferrand, , France
Chs Philippe Pinel (Fr0017)
Dury, , France
Centre Medical Ambroise Pare (FR0005)
Élancourt, , France
Hopital Albert Michallon- CHU Grenoble Alpes (FR0021)
Grenoble, , France
Clinique Korian La Crau (FR0063)
La Crau, , France
Dr. Norbert Rigaud Md, Office Of (FR0028)
Lamagistère, , France
Centre Hospitalier Esquirol (FR0038)
Limoges, , France
Clinique Mon Repos (FR0057)
Marseille, , France
Centre Hospitalier De Martigues (FR0064)
Martigues, , France
Hopital de la Colombiere (FR0026)
Montpellier, , France
Cabinet Medical (FR0043)
Mulhouse, , France
Maison Des Addictions (FR0006)
Nancy, , 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)
Nîmes, , France
Centre Hospitalier Sainte Anne (FR0029)
Paris, , France
Camp Antonin Artaud (FR0001)
Quimper, , France
Dr. Dominique Januel, MD Office of (FR0044)
Rueil-Malmaison, , France
Unites De Soins Romain Rolland (FR0012)
Saint-Denis, , France
Hopital Nord (FR0042)
Saint-Priest-en-Jarez, , France
Dr Lousqui Charles MD, Office of (FR0033)
Strasbourg, , 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
Hopital De Psychiatrie (FR0009)
Toulouse, , France
Dr. David Modavi Md, Office Of (FR0034)
Toulouse, , France
Dr. Joel Pon MD, Office of (FR0027)
Toulouse, , France
Ospedale Versilia (IT0002)
Lucca, LU, Italy
Casa di Cura Villa San Benedetto Menni, Suore Ospedaliere (IT0025)
Albese Con Cassano, Milano, Italy
Asl Roma G (IT0005)
Colleferro, Roma, Italy
Ospedale Sant'Andrea Hospital (IT0003)
Rome, Roma, Italy
Insituto Di Ricovero E Cura A Carattere Scientifico San Raffaele Pisana (IT0035)
Roma, Rome, Italy
DSM Giulianova - ospedale di Giulianova (IT0019)
Giulianova, Teramo, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga (IT0004)
Orbassano, Torino, Italy
Istituto di Neuroscienze (INS) (IT0028)
Florence, Tuscany, Italy
Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0034)
Perugia, Umbria, 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
DSM Cosenza (IT0015)
Cosenza, , Italy
Psichiatria Ospedale Oglio Po (IT0023)
Cremona, , Italy
Ospedali Riuniti Foggia (IT0007)
Foggia, , Italy
Dipartimento Salute Mentale ASL Lecce (IT0009)
Lecce, , Italy
ASST Lodi (IT0042)
Lodi, , 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)
Milan, , Italy
Disturbi Depressivi Ospedale Luigi Sacco Polo Universitario Psichiatria 2 - CTDD (IT0033)
Milan, , Italy
Pneumology Clinic - AO San Gerardo (IT0017)
Monza, , Italy
Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma (IT0032)
Roma, , Italy
Villa Von Siebenthal (IT0008)
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, , Italy
Countries
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References
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Di Nicola M, Adair M, Rieckmann A, Christensen M C. Effectiveness of vortioxetine in elderly patients with major depressive disorder in real-world clinical practice: Results from the RELIEVE study. J Psychopharmacol. 2024 Jul;38(7):615-623. doi: 10.1177/02698811241260996.
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. 2023 Mar;37(3):279-288. doi: 10.1177/02698811221132468. Epub 2022 Nov 15.
Other Identifiers
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17354N
Identifier Type: -
Identifier Source: org_study_id
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