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Major Depressive DisorderRELIEVENCT03555136

Real-life Effectiveness of Vortioxetine in Depression

An observational study of Major Depressive Disorder, run by H. Lundbeck A/S at 106 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Worldwide Major Depressive Disorder (MDD) has significant negative personal, societal and economic consequences. Vortioxetine (Brintellix®) is a new antidepressant authorized since 2013. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Major Depressive Disorder
What is being tested?
Vortioxetine
How many people
992 participants
Where
106 sitesin 4 countries
Study dates
17 Nov 2017to 31 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Outpatients from primary, secondary or tertiary care centres

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

106 sites in 4 countries.

106 sites in 4 countries

France37 sites

  • Dr. Philippe Remaud MD, Office of (FR0010)

    Angers, 49000

  • Chru Houtel Dieu (FR0020)

    Angers, 49033

  • Clinique Villa Bleue (FR0008)

    Angoulême, 16000

  • Clinique Clinea orgemont (FR0061)

    Argenteuil, 95100

  • Centre Hospitalier De Blois (FR0011)

    Blois, 41016

  • CHS Le Vinatier (FR0013)

    Bron, Cedex, 69678

  • CH De Novillars (FR0025)

    Chalezeule, 25220

  • CHU Clermont-Ferrand, Hopital Gabriel Montpied (FR0037)

    Clermont-Ferrand, 63000

  • Chs Philippe Pinel (Fr0017)

    Dury, 80480

  • Centre Medical Ambroise Pare (FR0005)

    Élancourt, 78990

  • Hopital Albert Michallon- CHU Grenoble Alpes (FR0021)

    Grenoble, 38043

  • Clinique Korian La Crau (FR0063)

    La Crau, 83260

  • Dr. Norbert Rigaud Md, Office Of (FR0028)

    Lamagistère, 82360

  • Cmpi (FR0004)

    Le Vésinet, Yvelines, 78110

  • Centre Hospitalier Esquirol (FR0038)

    Limoges, 87025

  • Clinique Mon Repos (FR0057)

    Marseille, 13008

  • Centre Hospitalier De Martigues (FR0064)

    Martigues, 13500

  • Hopital de la Colombiere (FR0026)

    Montpellier, 34295

  • Cabinet Medical (FR0043)

    Mulhouse, 68100

  • Maison Des Addictions (FR0006)

    Nancy, 54037

  • CHU de Nantes (FR0023)

    Nantes, Cedex 1, 44000

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

    Nice, 06002

  • Centre Hospitalier Universitaire de Nimes (FR0018)

    Nîmes, 30090

  • Centre Hospitalier Sainte Anne (FR0029)

    Paris, 75014

  • Camp Antonin Artaud (FR0001)

    Quimper, 29000

  • Centre Hospitalier Bp29 (FR0015)

    Rouffach, Alsace, 68250

  • Dr. Dominique Januel, MD Office of (FR0044)

    Rueil-Malmaison, 92500

  • Unites De Soins Romain Rolland (FR0012)

    Saint-Denis, 93200

  • Hopital Nord (FR0042)

    Saint-Priest-en-Jarez, 42277

  • Dr Philippe Marmor, MD, Office of (FR0035)

    Strasbourg, Alsace, 67000

  • Dr Lousqui Charles MD, Office of (FR0033)

    Strasbourg, 67000

  • Hopital civil (FR0039)

    Strasbourg, 67901

  • Cabinet Du Dr D Bonneau (FR0036)

    Thouars, 79100

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

    Toulon, 83000

  • Hopital De Psychiatrie (FR0009)

    Toulouse, 31059

  • Dr. David Modavi Md, Office Of (FR0034)

    Toulouse, 31200

  • Dr. Joel Pon MD, Office of (FR0027)

    Toulouse, 31200

Other trials in France

United States31 sites

  • Pearl Health Clinic (US0001)

    Ammon, Idaho, 83406

  • Quest Therapeutics Of Avon Lake (US0002)

    Avon Lake, Ohio, 44012

  • Da Vinci Research Institute (US0063)

    Boca Raton, Florida, 33487

  • Harmonex Neuroscience Research Inc (US0072)

    Dothan, Alabama, 36303

  • Core Clinical Research (US0067)

    Everett, Washington, 98201

  • Psychiatric Consultants, Pc (US0028)

    Franklin, Tennessee, 37067

  • Bay Pointe Behavioral Health (US0030)

    Friendswood, Texas, 77546

  • Sarkis Clinical Trials (US0066)

    Gainesville, Florida, 32607

  • Southern Illinois Associates LLC (US0079)

    Glen Carbon, Illinois, 62034

  • Maxblue Institute (US0038)

    Hialeah, Florida, 33018

  • Biopharma Informatic, LLC (US0031)

    Houston, Texas, 77084

  • Biopharma Informatic, LLC

    Houston, Texas, 77084

  • Office Of Amit Vijapura, Md (US0057)

    Jacksonville, Florida, 32256

  • University Of Kansas Cancer Center (US0078)

    Kansas City, Kansas, 66160

  • Alivation Research, LLC (US0020)

    Lincoln, Nebraska, 68526

  • Northwest Behavioral Research Center (US0007)

    Marietta, Georgia, 30060

  • International Research Associates LLC (US0060)

    Miami, Florida, 33183

  • AMR- Baber Research, Inc. (US0006)

    Naperville, Illinois, 60563

  • Pharmacology Research Institute (US0045)

    Newport Beach, California, 92660

  • Meridian Clinical Research (US0027)

    Norfolk, Nebraska, 68701

  • North County Clinical Research (Nccr) (US0071)

    Oceanside, California, 92054

  • Millenia Psychiatry and Research, Inc. (US0015)

    Orlando, Florida, 32839

  • West park Springs (US0073)

    Richmond, Texas, 77407

  • Finger Lakes Clinical Research (US0005)

    Rochester, New York, 14618

  • Rochester Center For Behavioral Medicine (US0059)

    Rochester Hills, Michigan, 48307

  • Neuroscientific Insights (US0029)

    Rockville, Maryland, 20852

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

    Saint Charles, Missouri, 63304

  • Breakthrough Clinical Trials (US0074)

    San Bernardino, California, 92408

  • Professional Health Care of Pinellas (US0050)

    St. Petersburg, Florida, 33713

  • Viking Clinical Research Center LLC (US0033)

    Temecula, California, 92591

  • Center For Advanced Improvement (US0011)

    Tucson, Arizona, 85719

Other trials in United States

Italy28 sites

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

    Albese Con Cassano, Milano, 22032

  • ASST Papa Giovanni XXIII (IT0016)

    Bergamo, 24127

  • Università degli Studi di Brescia (IT0029)

    Brescia, 25123

  • Universita Degli Studi Di Catania - Azienda Policlinico (IT0030)

    Catania, 95125

  • Universita Degli Studi Magna Graecia Di Catanzaro (IT0006)

    Catanzaro, 88100

  • Asl Roma G (IT0005)

    Colleferro, Roma, 34

  • DSM Cosenza (IT0015)

    Cosenza, 87100

  • Psichiatria Ospedale Oglio Po (IT0023)

    Cremona, 26100

  • Istituto di Neuroscienze (INS) (IT0028)

    Florence, Tuscany, 50100

  • Ospedali Riuniti Foggia (IT0007)

    Foggia, 71100

  • DSM Giulianova - ospedale di Giulianova (IT0019)

    Giulianova, Teramo, 64021

  • Dipartimento Salute Mentale ASL Lecce (IT0009)

    Lecce, 73100

  • ASST Lodi (IT0042)

    Lodi, 20100

  • Ospedale Versilia (IT0002)

    Lucca, LU, 55043

  • Azienda Toscana nord ovest zona Apuane (IT0039)

    Massa, 54100

  • Policlinico Universitario Di Messina (IT0031)

    Messina, 98125

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

    Milan, 20142

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

    Milan, 20157

  • Pneumology Clinic - AO San Gerardo (IT0017)

    Monza, 20900

  • Azienda Ospedaliero-Universitaria San Luigi Gonzaga (IT0004)

    Orbassano, Torino, 10043

  • Azienda Ospedaliera di Perugia - Policlinico Monteluce (IT0034)

    Perugia, Umbria, 06122

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

    Roma, Rome, 00163

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

    Roma, 00185

  • Villa Von Siebenthal (IT0008)

    Roma, 45

  • Ospedale Sant'Andrea Hospital (IT0003)

    Rome, Roma, 00189

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

    Rome, 00168

  • Ospedale Alfredo Fiorini (IT0026)

    Terracina, 04019

  • University Of Turin (IT0001)

    Turin, 10126

Other trials in Italy

Canada10 sites

  • Chatham-Kent Clinical Trials Research Centre (CA0007)

    Chatham, Ontario, N7L 1C1

  • Chokka Center For Integrative Health (CA0001)

    Edmonton, Alberta, T6L 6W6

  • Queen's University-Hotel Dieu Hospital (CA0011)

    Kingston, Ontario, K7L 2Y6

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

    London, Ontario, N6C0A7

  • GCP Research (CA0013)

    Montreal, Quebec, H1M 1B1

  • Mana Research Inc (CA0012)

    Point Claire, Quebec, H9R4S3

  • Alpha Recherche Clinique (CA0009)

    Québec, Quebec, G3K 2P8

  • Alpha Recherche Clinique (CA0017)

    Québec, G2J0C4

  • Start Clinic For Mood And Anxiety Disorders (CA0006)

    Toronto, Ontario, M4W 2N4

  • Jodha Tishon Inc (CA0008)

    Toronto, Ontario, M5G 1N8

Other trials in Canada

About this study

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

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.

Read more

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.

Being tested
Vortioxetine
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VortioxetineDrug

    Treatment with vortioxetine as per local SmPC

Study groups in NCT03555136
Study groupRoleWhat they receive
Patients initiating vortioxetine treatmentPatients with major depressive disorder initiating treatment with vortioxetine
Receives: Drug: Vortioxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Change since baseline at week 12 and 24

Secondary outcomes (2)

  1. 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

    Measured: Change since baseline at week 12 and 24

  2. 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

    Measured: Change since baseline at week 12 and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2018
  2. Study start17 Nov 2017
  3. Primary completion31 Jan 2021
  4. Study completion31 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
992 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03555136
Sponsor's protocol ID
17354N
Acronym
RELIEVE
Status last verified
May 2021
First submitted
1 Jun 2018
Last updated
27 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 39077889

  • 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.

    PubMed 36377523

Questions about this trial

What is this clinical trial studying?

An observational study of Major Depressive Disorder, run by H. Lundbeck A/S at 106 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 106 sites in France, United States, Italy, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sheehan Disability Scale (SDS) (time frame: Change since baseline at week 12 and 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03555136, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.

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