Clinical trial NCT03555136: Real-life Effectiveness of Vortioxetine in Depression
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depressive Disorder
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2018-06-13
Enrollment: 992
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients from primary, secondary or tertiary care centres

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sheehan Disability Scale (SDS)
timeFrame: Change since baseline at week 12 and 24
Secondary outcomes:
measure: The Patient Health Questionnaire - nine items (PHQ-9)
timeFrame: Change since baseline at week 12 and 24
measure: Perceived Deficits Questionnaire - Depression - five items (PDQ-D-5)
timeFrame: Change since baseline at week 12 and 24
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex Neuroscience Research Inc (US0072)
state: Alabama
city: Tucson
country: United States
facility: Center For Advanced Improvement (US0011)
state: Arizona
city: Newport Beach
country: United States
facility: Pharmacology Research Institute (US0045)
state: California
city: Oceanside
country: United States
facility: North County Clinical Research (Nccr) (US0071)
state: California
city: San Bernardino
country: United States
facility: Breakthrough Clinical Trials (US0074)
state: California
city: Temecula
country: United States
facility: Viking Clinical Research Center LLC (US0033)
state: California
city: Boca Raton
country: United States
facility: Da Vinci Research Institute (US0063)
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials (US0066)
state: Florida
city: Hialeah
country: United States
facility: Maxblue Institute (US0038)
state: Florida
city: Jacksonville
country: United States
facility: Office Of Amit Vijapura, Md (US0057)
state: Florida
city: Miami
country: United States
facility: International Research Associates LLC (US0060)
state: Florida
city: Orlando
country: United States
facility: Millenia Psychiatry and Research, Inc. (US0015)
state: Florida
city: Saint Petersburg
country: United States
facility: Professional Health Care of Pinellas (US0050)
state: Florida
city: Marietta
country: United States
facility: Northwest Behavioral Research Center (US0007)
state: Georgia
city: Ammon
country: United States
facility: Pearl Health Clinic (US0001)
state: Idaho
city: Glen Carbon
country: United States
facility: Southern Illinois Associates LLC (US0079)
state: Illinois
city: Naperville
country: United States
facility: AMR- Baber Research, Inc. (US0006)
state: Illinois
city: Kansas City
country: United States
facility: University Of Kansas Cancer Center (US0078)
state: Kansas
city: Rockville
country: United States
facility: Neuroscientific Insights (US0029)
state: Maryland
city: Rochester Hills
country: United States
facility: Rochester Center For Behavioral Medicine (US0059)
state: Michigan
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates - Midwest Research Group (US0039)
state: Missouri
city: Lincoln
country: United States
facility: Alivation Research, LLC (US0020)
state: Nebraska
city: Norfolk
country: United States
facility: Meridian Clinical Research (US0027)
state: Nebraska
city: Rochester
country: United States
facility: Finger Lakes Clinical Research (US0005)
state: New York
city: Avon Lake
country: United States
facility: Quest Therapeutics Of Avon Lake (US0002)
state: Ohio
city: Franklin
country: United States
facility: Psychiatric Consultants, Pc (US0028)
state: Tennessee
city: Friendswood
country: United States
facility: Bay Pointe Behavioral Health (US0030)
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC (US0031)
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Richmond
country: United States
facility: West park Springs (US0073)
state: Texas
city: Everett
country: United States
facility: Core Clinical Research (US0067)
state: Washington
city: Edmonton
country: Canada
facility: Chokka Center For Integrative Health (CA0001)
state: Alberta
city: Chatham
country: Canada
facility: Chatham-Kent Clinical Trials Research Centre (CA0007)
state: Ontario
city: Kingston
country: Canada
facility: Queen's University-Hotel Dieu Hospital (CA0011)
state: Ontario
city: London
country: Canada
facility: St. Joseph's Health Care London - Parkwood Institute (Regional Mental Health Care London and Parkwood Hospital) (CA0004)
state: Ontario
city: Toronto
country: Canada
facility: Start Clinic For Mood And Anxiety Disorders (CA0006)
state: Ontario
city: Toronto
country: Canada
facility: Jodha Tishon Inc (CA0008)
state: Ontario
city: Montreal
country: Canada
facility: GCP Research (CA0013)
state: Quebec
city: Point Claire
country: Canada
facility: Mana Research Inc (CA0012)
state: Quebec
city: Quebec City
country: Canada
facility: Alpha Recherche Clinique (CA0009)
state: Quebec
city: Quebec
country: Canada
facility: Alpha Recherche Clinique (CA0017)
city: Rouffach
country: France
facility: Centre Hospitalier Bp29 (FR0015)
state: Alsace
city: Strasbourg
country: France
facility: Dr Philippe Marmor, MD, Office of (FR0035)
state: Alsace
city: Nantes
country: France
facility: CHU de Nantes (FR0023)
state: Cedex 1
city: Bron Cedex
country: France
facility: CHS Le Vinatier (FR0013)
state: Cedex
city: Le Vesinet
country: France
facility: Cmpi (FR0004)
state: Yvelines
city: Angers Cedex
country: France
facility: Chru Houtel Dieu (FR0020)
city: Angers
country: France
facility: Dr. Philippe Remaud MD, Office of (FR0010)
city: Angouleme
country: France
facility: Clinique Villa Bleue (FR0008)
city: Argenteuil
country: France
facility: Clinique Clinea orgemont (FR0061)
city: Blois
country: France
facility: Centre Hospitalier De Blois (FR0011)
city: Chalezeule
country: France
facility: CH De Novillars (FR0025)
city: Clermont Ferrand Cedex 1
country: France
facility: CHU Clermont-Ferrand, Hopital Gabriel Montpied (FR0037)
city: Dury
country: France
facility: Chs Philippe Pinel (Fr0017)
city: Elancourt
country: France
facility: Centre Medical Ambroise Pare (FR0005)
city: Grenoble cedex 9
country: France
facility: Hopital Albert Michallon- CHU Grenoble Alpes (FR0021)
city: La Crau
country: France
facility: Clinique Korian La Crau (FR0063)
city: Lamagistere
country: France
facility: Dr. Norbert Rigaud Md, Office Of (FR0028)
city: Limoges
country: France
facility: Centre Hospitalier Esquirol (FR0038)
city: Marseille
country: France
facility: Clinique Mon Repos (FR0057)
city: Martigues Cedex
country: France
facility: Centre Hospitalier De Martigues (FR0064)
city: Montpellier Cedex
country: France
facility: Hopital de la Colombiere (FR0026)
city: Mulhouse
country: France
facility: Cabinet Medical (FR0043)
city: Nancy
country: France
facility: Maison Des Addictions (FR0006)
city: Nice
country: France
facility: Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur - Clinique de Psychiatrie et de Psychologie Medicale (FR0041)
city: Nimes
country: France
facility: Centre Hospitalier Universitaire de Nimes (FR0018)
city: Paris
country: France
facility: Centre Hospitalier Sainte Anne (FR0029)
city: Quimper
country: France
facility: Camp Antonin Artaud (FR0001)
city: Rueil-Malmaison
country: France
facility: Dr. Dominique Januel, MD Office of (FR0044)
city: St Denis
country: France
facility: Unites De Soins Romain Rolland (FR0012)
city: St Priest En Jarez Cedex
country: France
facility: Hopital Nord (FR0042)
city: Strasbourg
country: France
facility: Dr Lousqui Charles MD, Office of (FR0033)
city: Strasbourg
country: France
facility: Hopital civil (FR0039)
city: Thouars
country: France
facility: Cabinet Du Dr D Bonneau (FR0036)
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer - Hôpital Sainte Musse (FR0019)
city: Toulouse
country: France
facility: Hopital De Psychiatrie (FR0009)
city: Toulouse
country: France
facility: Dr. David Modavi Md, Office Of (FR0034)
city: Toulouse
country: France
facility: Dr. Joel Pon MD, Office of (FR0027)
city: Lucca
country: Italy
facility: Ospedale Versilia (IT0002)
state: LU
city: Albese con Cassano
country: Italy
facility: Casa di Cura Villa San Benedetto Menni, Suore Ospedaliere (IT0025)
state: Milano
city: Colleferro
country: Italy
facility: Asl Roma G (IT0005)
state: Roma
city: Rome
country: Italy
facility: Ospedale Sant'Andrea Hospital (IT0003)
state: Roma
city: Roma
country: Italy
facility: Insituto Di Ricovero E Cura A Carattere Scientifico San Raffaele Pisana (IT0035)
state: Rome
city: Giulianova
country: Italy
facility: DSM Giulianova - ospedale di Giulianova (IT0019)
state: Teramo
city: Orbassano
country: Italy
facility: Azienda Ospedaliero-Universitaria San Luigi Gonzaga (IT0004)
state: Torino
city: Firenze
country: Italy
facility: Istituto di Neuroscienze (INS) (IT0028)
state: Toscana
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0034)
state: Umbria
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII (IT0016)
city: Brescia
country: Italy
facility: Università degli Studi di Brescia (IT0029)
city: Catania
country: Italy
facility: Universita Degli Studi Di Catania - Azienda Policlinico (IT0030)
city: Catanzaro
country: Italy
facility: Universita Degli Studi Magna Graecia Di Catanzaro (IT0006)
city: Cosenza
country: Italy
facility: DSM Cosenza (IT0015)
city: Cremona
country: Italy
facility: Psichiatria Ospedale Oglio Po (IT0023)
city: Foggia
country: Italy
facility: Ospedali Riuniti Foggia (IT0007)
city: Lecce
country: Italy
facility: Dipartimento Salute Mentale ASL Lecce (IT0009)
city: Lodi
country: Italy
facility: ASST Lodi (IT0042)
city: Massa
country: Italy
facility: Azienda Toscana nord ovest zona Apuane (IT0039)
city: Messina
country: Italy
facility: Policlinico Universitario Di Messina (IT0031)
city: Milano
country: Italy
facility: Azienda Ospedaliera San Paolo - Universita Degli Studi Di Milano (IT0014)
city: Milano
country: Italy
facility: Disturbi Depressivi Ospedale Luigi Sacco Polo Universitario Psichiatria 2 - CTDD (IT0033)
city: Monza
country: Italy
facility: Pneumology Clinic - AO San Gerardo (IT0017)
city: Roma
country: Italy
facility: Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma (IT0032)
city: Roma
country: Italy
facility: Villa Von Siebenthal (IT0008)
city: Rome
country: Italy
facility: Universita Cattolica del Sacro Cuore (University of Sacred Heart Policlinico A. Gemelli) (IT0018)
city: Terracina
country: Italy
facility: Ospedale Alfredo Fiorini (IT0026)
city: Turin
country: Italy
facility: University Of Turin (IT0001)
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: 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.