Real-life Effectiveness of Vortioxetine in Depression
- Registration Number
- NCT03555136
- Lead Sponsor
- H. Lundbeck A/S
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 992
- 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)
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients initiating vortioxetine treatment Vortioxetine Patients with major depressive disorder initiating treatment with vortioxetine
- Primary Outcome Measures
Name Time Method Sheehan Disability Scale (SDS) 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 Outcome Measures
Name Time Method Perceived Deficits Questionnaire - Depression - five items (PDQ-D-5) 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
The Patient Health Questionnaire - nine items (PHQ-9) 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
Trial Locations
- Locations (106)
Pharmacology Research Institute (US0045)
🇺🇸Newport Beach, California, United States
Maxblue Institute (US0038)
🇺🇸Hialeah, Florida, United States
Northwest Behavioral Research Center (US0007)
🇺🇸Marietta, Georgia, United States
Alivation Research, LLC (US0020)
🇺🇸Lincoln, Nebraska, United States
Queen's University-Hotel Dieu Hospital (CA0011)
🇨🇦Kingston, Ontario, Canada
Jodha Tishon Inc (CA0008)
🇨🇦Toronto, Ontario, Canada
University Of Kansas Cancer Center (US0078)
🇺🇸Kansas City, Kansas, United States
Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0034)
🇮🇹Perugia, Umbria, Italy
Dr. Dominique Januel, MD Office of (FR0044)
🇫🇷Rueil-Malmaison, France
Center For Advanced Improvement (US0011)
🇺🇸Tucson, Arizona, United States
Harmonex Neuroscience Research Inc (US0072)
🇺🇸Dothan, Alabama, United States
Da Vinci Research Institute (US0063)
🇺🇸Boca Raton, Florida, United States
North County Clinical Research (Nccr) (US0071)
🇺🇸Oceanside, California, United States
Viking Clinical Research Center LLC (US0033)
🇺🇸Temecula, California, United States
Office Of Amit Vijapura, Md (US0057)
🇺🇸Jacksonville, Florida, United States
Professional Health Care of Pinellas (US0050)
🇺🇸Saint Petersburg, Florida, United States
Southern Illinois Associates LLC (US0079)
🇺🇸Glen Carbon, Illinois, United States
Pearl Health Clinic (US0001)
🇺🇸Ammon, Idaho, United States
Neuroscientific Insights (US0029)
🇺🇸Rockville, Maryland, United States
AMR- Baber Research, Inc. (US0006)
🇺🇸Naperville, Illinois, 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
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
West park Springs (US0073)
🇺🇸Richmond, Texas, United States
Core Clinical Research (US0067)
🇺🇸Everett, Washington, United States
Chatham-Kent Clinical Trials Research Centre (CA0007)
🇨🇦Chatham, 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
Mana Research Inc (CA0012)
🇨🇦Point Claire, Quebec, Canada
GCP Research (CA0013)
🇨🇦Montreal, Quebec, Canada
Alpha Recherche Clinique (CA0009)
🇨🇦Quebec City, Quebec, Canada
Alpha Recherche Clinique (CA0017)
🇨🇦Quebec, Canada
CHS Le Vinatier (FR0013)
🇫🇷Bron Cedex, Cedex, France
Centre Hospitalier Bp29 (FR0015)
🇫🇷Rouffach, Alsace, France
Dr Philippe Marmor, MD, Office of (FR0035)
🇫🇷Strasbourg, Alsace, France
Cmpi (FR0004)
🇫🇷Le Vesinet, Yvelines, France
CHU de Nantes (FR0023)
🇫🇷Nantes, Cedex 1, France
Chru Houtel Dieu (FR0020)
🇫🇷Angers Cedex, France
Dr. Philippe Remaud MD, Office of (FR0010)
🇫🇷Angers, France
Clinique Villa Bleue (FR0008)
🇫🇷Angouleme, France
Clinique Clinea orgemont (FR0061)
🇫🇷Argenteuil, France
Centre Hospitalier De Blois (FR0011)
🇫🇷Blois, France
CH De Novillars (FR0025)
🇫🇷Chalezeule, France
Chs Philippe Pinel (Fr0017)
🇫🇷Dury, France
CHU Clermont-Ferrand, Hopital Gabriel Montpied (FR0037)
🇫🇷Clermont Ferrand Cedex 1, France
Dr. Norbert Rigaud Md, Office Of (FR0028)
🇫🇷Lamagistere, France
Centre Hospitalier Esquirol (FR0038)
🇫🇷Limoges, 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
Centre Hospitalier De Martigues (FR0064)
🇫🇷Martigues Cedex, France
Hopital de la Colombiere (FR0026)
🇫🇷Montpellier Cedex, France
Clinique Mon Repos (FR0057)
🇫🇷Marseille, 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)
🇫🇷Nimes, France
Unites De Soins Romain Rolland (FR0012)
🇫🇷St Denis, France
Hopital Nord (FR0042)
🇫🇷St Priest En Jarez Cedex, France
Centre Hospitalier Sainte Anne (FR0029)
🇫🇷Paris, France
Camp Antonin Artaud (FR0001)
🇫🇷Quimper, France
Dr Lousqui Charles MD, Office of (FR0033)
🇫🇷Strasbourg, France
Cabinet Du Dr D Bonneau (FR0036)
🇫🇷Thouars, France
Hopital civil (FR0039)
🇫🇷Strasbourg, France
Dr. David Modavi Md, Office Of (FR0034)
🇫🇷Toulouse, France
Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer - Hôpital Sainte Musse (FR0019)
🇫🇷Toulon, France
Hopital De Psychiatrie (FR0009)
🇫🇷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
DSM Giulianova - ospedale di Giulianova (IT0019)
🇮🇹Giulianova, Teramo, Italy
Insituto Di Ricovero E Cura A Carattere Scientifico San Raffaele Pisana (IT0035)
🇮🇹Roma, Rome, Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga (IT0004)
🇮🇹Orbassano, Torino, Italy
Istituto di Neuroscienze (INS) (IT0028)
🇮🇹Firenze, Toscana, Italy
Università degli Studi di Brescia (IT0029)
🇮🇹Brescia, Italy
Universita Degli Studi Di Catania - Azienda Policlinico (IT0030)
🇮🇹Catania, Italy
ASST Papa Giovanni XXIII (IT0016)
🇮🇹Bergamo, Italy
DSM Cosenza (IT0015)
🇮🇹Cosenza, Italy
Psichiatria Ospedale Oglio Po (IT0023)
🇮🇹Cremona, Italy
Universita Degli Studi Magna Graecia Di Catanzaro (IT0006)
🇮🇹Catanzaro, Italy
Ospedali Riuniti Foggia (IT0007)
🇮🇹Foggia, Italy
ASST Lodi (IT0042)
🇮🇹Lodi, Italy
Azienda Toscana nord ovest zona Apuane (IT0039)
🇮🇹Massa, Italy
Dipartimento Salute Mentale ASL Lecce (IT0009)
🇮🇹Lecce, Italy
Azienda Ospedaliera San Paolo - Universita Degli Studi Di Milano (IT0014)
🇮🇹Milano, Italy
Policlinico Universitario Di Messina (IT0031)
🇮🇹Messina, Italy
Disturbi Depressivi Ospedale Luigi Sacco Polo Universitario Psichiatria 2 - CTDD (IT0033)
🇮🇹Milano, 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
University Of Turin (IT0001)
🇮🇹Turin, Italy
Universita Cattolica del Sacro Cuore (University of Sacred Heart Policlinico A. Gemelli) (IT0018)
🇮🇹Rome, Italy
Ospedale Alfredo Fiorini (IT0026)
🇮🇹Terracina, Italy
Breakthrough Clinical Trials (US0074)
🇺🇸San Bernardino, California, United States
Sarkis Clinical Trials (US0066)
🇺🇸Gainesville, Florida, United States
International Research Associates LLC (US0060)
🇺🇸Miami, Florida, United States
Biopharma Informatic, LLC (US0031)
🇺🇸Houston, Texas, United States
Millenia Psychiatry and Research, Inc. (US0015)
🇺🇸Orlando, Florida, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Chokka Center For Integrative Health (CA0001)
🇨🇦Edmonton, Alberta, Canada