Real-life Effectiveness of Vortioxetine in Depression

NCT03555136 | Completed FDA Drug

• 1 other identifier: 17354N
• Study Type: observational
• Target: 992
• Locations: 4 countries
• Sites: 106

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The Patient Health Questionnaire - nine items (PHQ-9)

  Change since baseline at week 12 and 24

• Perceived Deficits Questionnaire - Depression - five items (PDQ-D-5)

  Change since baseline at week 12 and 24

Study Arms (1)

Patients initiating vortioxetine treatment

Patients with major depressive disorder initiating treatment with vortioxetine

Drug: Vortioxetine

Interventions

Vortioxetine DRUG

Treatment with vortioxetine as per local SmPC

Patients initiating vortioxetine treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Outpatients from primary, secondary or tertiary care centres

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (106)

Harmonex Neuroscience Research Inc (US0072)

Dothan, Alabama, 36303, United States

Location

Center For Advanced Improvement (US0011)

Tucson, Arizona, 85719, United States

Location

Pharmacology Research Institute (US0045)

Newport Beach, California, 92660, United States

Location

North County Clinical Research (Nccr) (US0071)

Oceanside, California, 92054, United States

Location

Breakthrough Clinical Trials (US0074)

San Bernardino, California, 92408, United States

Location

Viking Clinical Research Center LLC (US0033)

Temecula, California, 92591, United States

Location

Da Vinci Research Institute (US0063)

Boca Raton, Florida, 33487, United States

Location

Sarkis Clinical Trials (US0066)

Gainesville, Florida, 32607, United States

Location

Maxblue Institute (US0038)

Hialeah, Florida, 33018, United States

Location

Office Of Amit Vijapura, Md (US0057)

Jacksonville, Florida, 32256, United States

Location

International Research Associates LLC (US0060)

Miami, Florida, 33183, United States

Location

Millenia Psychiatry and Research, Inc. (US0015)

Orlando, Florida, 32839, United States

Location

Professional Health Care of Pinellas (US0050)

St. Petersburg, Florida, 33713, United States

Location

Northwest Behavioral Research Center (US0007)

Marietta, Georgia, 30060, United States

Location

Pearl Health Clinic (US0001)

Ammon, Idaho, 83406, United States

Location

Southern Illinois Associates LLC (US0079)

Glen Carbon, Illinois, 62034, United States

Location

AMR- Baber Research, Inc. (US0006)

Naperville, Illinois, 60563, United States

Location

University Of Kansas Cancer Center (US0078)

Kansas City, Kansas, 66160, United States

Location

Neuroscientific Insights (US0029)

Rockville, Maryland, 20852, United States

Location

Rochester Center For Behavioral Medicine (US0059)

Rochester Hills, Michigan, 48307, United States

Location

St. Charles Psychiatric Associates - Midwest Research Group (US0039)

Saint Charles, Missouri, 63304, United States

Location

Alivation Research, LLC (US0020)

Lincoln, Nebraska, 68526, United States

Location

Meridian Clinical Research (US0027)

Norfolk, Nebraska, 68701, United States

Location

Finger Lakes Clinical Research (US0005)

Rochester, New York, 14618, United States

Location

Quest Therapeutics Of Avon Lake (US0002)

Avon Lake, Ohio, 44012, United States

Location

Psychiatric Consultants, Pc (US0028)

Franklin, Tennessee, 37067, United States

Location

Bay Pointe Behavioral Health (US0030)

Friendswood, Texas, 77546, United States

Location

Biopharma Informatic, LLC (US0031)

Houston, Texas, 77084, United States

Location

Biopharma Informatic, LLC

Houston, Texas, 77084, United States

Location

West park Springs (US0073)

Richmond, Texas, 77407, United States

Location

Core Clinical Research (US0067)

Everett, Washington, 98201, United States

Location

Chokka Center For Integrative Health (CA0001)

Edmonton, Alberta, T6L 6W6, Canada

Location

Chatham-Kent Clinical Trials Research Centre (CA0007)

Chatham, Ontario, N7L 1C1, Canada

Location

Queen's University-Hotel Dieu Hospital (CA0011)

Kingston, Ontario, K7L 2Y6, Canada

Location

St. Joseph's Health Care London - Parkwood Institute (Regional Mental Health Care London and Parkwood Hospital) (CA0004)

London, Ontario, N6C0A7, Canada

Location

Start Clinic For Mood And Anxiety Disorders (CA0006)

Toronto, Ontario, M4W 2N4, Canada

Location

Jodha Tishon Inc (CA0008)

Toronto, Ontario, M5G 1N8, Canada

Location

GCP Research (CA0013)

Montreal, Quebec, H1M 1B1, Canada

Location

Mana Research Inc (CA0012)

Point Claire, Quebec, H9R4S3, Canada

Location

Alpha Recherche Clinique (CA0009)

Québec, Quebec, G3K 2P8, Canada

Location

Alpha Recherche Clinique (CA0017)

Québec, G2J0C4, Canada

Location

Centre Hospitalier Bp29 (FR0015)

Rouffach, Alsace, 68250, France

Location

Dr Philippe Marmor, MD, Office of (FR0035)

Strasbourg, Alsace, 67000, France

Location

CHU de Nantes (FR0023)

Nantes, Cedex 1, 44000, France

Location

CHS Le Vinatier (FR0013)

Bron, Cedex, 69678, France

Location

Cmpi (FR0004)

Le Vésinet, Yvelines, 78110, France

Location

Dr. Philippe Remaud MD, Office of (FR0010)

Angers, 49000, France

Location

Chru Houtel Dieu (FR0020)

Angers, 49033, France

Location

Clinique Villa Bleue (FR0008)

Angoulême, 16000, France

Location

Clinique Clinea orgemont (FR0061)

Argenteuil, 95100, France

Location

Centre Hospitalier De Blois (FR0011)

Blois, 41016, France

Location

CH De Novillars (FR0025)

Chalezeule, 25220, France

Location

CHU Clermont-Ferrand, Hopital Gabriel Montpied (FR0037)

Clermont-Ferrand, 63000, France

Location

Chs Philippe Pinel (Fr0017)

Dury, 80480, France

Location

Centre Medical Ambroise Pare (FR0005)

Élancourt, 78990, France

Location

Hopital Albert Michallon- CHU Grenoble Alpes (FR0021)

Grenoble, 38043, France

Location

Clinique Korian La Crau (FR0063)

La Crau, 83260, France

Location

Dr. Norbert Rigaud Md, Office Of (FR0028)

Lamagistère, 82360, France

Location

Centre Hospitalier Esquirol (FR0038)

Limoges, 87025, France

Location

Clinique Mon Repos (FR0057)

Marseille, 13008, France

Location

Centre Hospitalier De Martigues (FR0064)

Martigues, 13500, France

Location

Hopital de la Colombiere (FR0026)

Montpellier, 34295, France

Location

Cabinet Medical (FR0043)

Mulhouse, 68100, France

Location

Maison Des Addictions (FR0006)

Nancy, 54037, France

Location

Centre Hospitalier Universitaire (CHU) de Nice - Hopital Pasteur - Clinique de Psychiatrie et de Psychologie Medicale (FR0041)

Nice, 06002, France

Location

Centre Hospitalier Universitaire de Nimes (FR0018)

Nîmes, 30090, France

Location

Centre Hospitalier Sainte Anne (FR0029)

Paris, 75014, France

Location

Camp Antonin Artaud (FR0001)

Quimper, 29000, France

Location

Dr. Dominique Januel, MD Office of (FR0044)

Rueil-Malmaison, 92500, France

Location

Unites De Soins Romain Rolland (FR0012)

Saint-Denis, 93200, France

Location

Hopital Nord (FR0042)

Saint-Priest-en-Jarez, 42277, France

Location

Dr Lousqui Charles MD, Office of (FR0033)

Strasbourg, 67000, France

Location

Hopital civil (FR0039)

Strasbourg, 67901, France

Location

Cabinet Du Dr D Bonneau (FR0036)

Thouars, 79100, France

Location

Centre Hospitalier Intercommunal Toulon - La Seyne sur Mer - Hôpital Sainte Musse (FR0019)

Toulon, 83000, France

Location

Hopital De Psychiatrie (FR0009)

Toulouse, 31059, France

Location

Dr. David Modavi Md, Office Of (FR0034)

Toulouse, 31200, France

Location

Dr. Joel Pon MD, Office of (FR0027)

Toulouse, 31200, France

Location

Ospedale Versilia (IT0002)

Lucca, LU, 55043, Italy

Location

Casa di Cura Villa San Benedetto Menni, Suore Ospedaliere (IT0025)

Albese Con Cassano, Milano, 22032, Italy

Location

Asl Roma G (IT0005)

Colleferro, Roma, 34, Italy

Location

Ospedale Sant'Andrea Hospital (IT0003)

Rome, Roma, 00189, Italy

Location

Insituto Di Ricovero E Cura A Carattere Scientifico San Raffaele Pisana (IT0035)

Roma, Rome, 00163, Italy

Location

DSM Giulianova - ospedale di Giulianova (IT0019)

Giulianova, Teramo, 64021, Italy

Location

Azienda Ospedaliero-Universitaria San Luigi Gonzaga (IT0004)

Orbassano, Torino, 10043, Italy

Location

Istituto di Neuroscienze (INS) (IT0028)

Florence, Tuscany, 50100, Italy

Location

Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0034)

Perugia, Umbria, 06122, Italy

Location

ASST Papa Giovanni XXIII (IT0016)

Bergamo, 24127, Italy

Location

Università degli Studi di Brescia (IT0029)

Brescia, 25123, Italy

Location

Universita Degli Studi Di Catania - Azienda Policlinico (IT0030)

Catania, 95125, Italy

Location

Universita Degli Studi Magna Graecia Di Catanzaro (IT0006)

Catanzaro, 88100, Italy

Location

DSM Cosenza (IT0015)

Cosenza, 87100, Italy

Location

Psichiatria Ospedale Oglio Po (IT0023)

Cremona, 26100, Italy

Location

Ospedali Riuniti Foggia (IT0007)

Foggia, 71100, Italy

Location

Dipartimento Salute Mentale ASL Lecce (IT0009)

Lecce, 73100, Italy

Location

ASST Lodi (IT0042)

Lodi, 20100, Italy

Location

Azienda Toscana nord ovest zona Apuane (IT0039)

Massa, 54100, Italy

Location

Policlinico Universitario Di Messina (IT0031)

Messina, 98125, Italy

Location

Azienda Ospedaliera San Paolo - Universita Degli Studi Di Milano (IT0014)

Milan, 20142, Italy

Location

Disturbi Depressivi Ospedale Luigi Sacco Polo Universitario Psichiatria 2 - CTDD (IT0033)

Milan, 20157, Italy

Location

Pneumology Clinic - AO San Gerardo (IT0017)

Monza, 20900, Italy

Location

Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma (IT0032)

Roma, 00185, Italy

Location

Villa Von Siebenthal (IT0008)

Roma, 45, Italy

Location

Universita Cattolica del Sacro Cuore (University of Sacred Heart Policlinico A. Gemelli) (IT0018)

Rome, 00168, Italy

Location

Ospedale Alfredo Fiorini (IT0026)

Terracina, 04019, Italy

Location

University Of Turin (IT0001)

Turin, 10126, Italy

Location

Related Publications (2)

• 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.

  PMID: 39077889 DERIVED

• 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.

  PMID: 36377523 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Vortioxetine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Email contact H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 13, 2018
• Study Start: November 17, 2017
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: May 27, 2021

Record last verified: 2021-05

Locations

US (31); CA (10); FR (37); IT (28)