Phase
Condition
Depression
Treatment
No Intervention
Clinical Study ID
Ages 18-74 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Meets the diagnostic criteria for single episode or recurrent major depressivedisorder (MDD) without psychotic features, according to either the tenth revision ofthe International Statistical Classification of Diseases and Related Health Problems (ICD-10) or the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
Is considered to suffer from a moderate or severe depressive syndrome, as defined bya Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than orequal to (>=) 22 at entry
Is initiating or is planning to initiate a new add-on antidepressant treatment perlocal prescribing information to treat the current depressive episode. In thecontext of this observational study, a new add-on antidepressant treatment isconsidered any new pharmacological or non-pharmacological treatment that isprescribed in addition to the current antidepressant treatment, inclusive of anselective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI or SNRI) with the intent to improve a participant's clinical depressivesyndrome. Accordingly, any dose escalation of an antidepressant prescribed prior tobaseline or the addition of any drug intended to increase the plasma-concentrationof an antidepressant prescribed prior to baseline is not considered a newantidepressant treatment; In parallel with the inclusion of participants consideredfor add-on strategy, in the United States only, a cohort of approximately 50participants who switch to a new single (monotherapy) pharmacological antidepressantagent of any antidepressant class per local prescribing information to replace thecurrent antidepressant treatment (that is, "monotherapy switch strategy") will beenrolled. The enrollment of participants with switch to monotherapy will bemonitored, and sites will be notified by the sponsor once the planned number for thecohort is achieved. Thereafter, only add-on strategy participants will be enrolled
Must be capable of providing informed consent (for example, able to read and write),based on the opinion of the participating physician. Must sign (or their legallyacceptable representative) an informed consent form indicating that he or sheunderstands the purpose of the study and that he or she agrees to have their datacollected and analyzed, in accordance with local requirements and the study protocol
Meets the criterion for inadequate response to a current antidepressant treatmentthat includes an SSRI or SNRI (monotherapy SSRI, monotherapy SNRI, combination ofantidepressants that includes SSRI/SNRI or SSRI/SNRI augmentation), administered atan adequate dose (as defined in the Massachusetts General Hospital - AntidepressantTreatment Response Questionnaire [MGH ATRQ]) and duration (at least 6 weeks) in thecurrent episode of depression
Exclusion
Exclusion Criteria:
Has a current or prior diagnosis of a psychotic disorder, MDD with psychoticfeatures, bipolar or related disorders or intellectual disability, according toDSM-5 or ICD-10
Participants who require an antidepressant (SSRI/SNRI) change (switch to anotherantidepressant monotherapy), except for a limited number of participants to berecruited in the United States only
Unstable general medical condition (for example, cardiovascular, respiratory,gastrointestinal, neurologic, hematologic, rheumatologic, immunologic, or endocrinedisorders) in the past 3 months that would compromise participation and normalroutine medical care per the physician's clinical judgment
Has lack of treatment response to the current antidepressant therapy that includes aSSRI/SNRI (that is, no [0%] symptomatic improvement despite adequate dose andduration of the antidepressant treatment) assessed using the MGH ATRQ
History of dementia or mild cognitive impairment. Physician's clinical judgmentshould document that participant is capable of complying with observational studyrequirements and being able to complete the appropriate scales
Has homicidal ideation/intent or is at imminent risk of suicide per the physician'sclinical judgment and/or based on the Columbia Suicide Severity Rating Scale (C-SSRS) corresponding to a response of "Yes" on Item 4 (active suicidal ideationwith some intent to act, without specific plan) or Item 5 (active suicidal ideationwith specific plan and intent)
Study Design
Connect with a study center
Hospital Fleni
Ciudad Autonoma Buenos Aires, C1428AQK
ArgentinaSite Not Available
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
Ciudad Autonoma de Buenos Aires, C1133AAH
ArgentinaSite Not Available
Hospital Italiano de Buenos Aires
Ciudad Autonoma de Buenos Aires, C1181ACH
ArgentinaSite Not Available
Resolution
Ciudad de Mendoza, M5502AHV
ArgentinaSite Not Available
CEN Consultorios Especializados en Neurociencias
Cordoba, 5000FJF
ArgentinaSite Not Available
CEN-Consultorios Especializados en Neurociencias
Cordoba, 5000FJF
ArgentinaActive - Recruiting
Centro Medico Luquez
Cordoba, X5006IKK
ArgentinaSite Not Available
Instituto Medico DAMIC
Cordoba, X5003DCE
ArgentinaSite Not Available
Hospital Sao Vicente de Paulo
Passo Fundo, 99010-080
BrazilSite Not Available
Centro Integrado Facili
Sao Bernardo do Campo, 09726 150
BrazilSite Not Available
Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto
Sao Jose Rio Preto, 15090-000
BrazilActive - Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
Sao Jose Rio Preto, 15090 000
BrazilSite Not Available
Clinica Viver - Centro de Desospitalizacao Humana
Sao Paulo, 04020-060
BrazilSite Not Available
Hospital Das Clinicas Da Faculdade De Medicina Da USP
Sao Paulo, 05403-000
BrazilSite Not Available
The Medical Arts Health Research Group
West Vancouver, British Columbia V7T 1C5
CanadaSite Not Available
Providence Care Hospital
Kingston, Ontario K7L 4X3
CanadaSite Not Available
Jodha Tishon Inc.
Toronto, Ontario M5S 3A3
CanadaSite Not Available
St. Michael's Hospital
Toronto, Ontario M5B 1W8
CanadaSite Not Available
Introspect Clinic
Ontario, K1C 1E9
CanadaSite Not Available
CHU Angers - Hopital Hotel Dieu
Angers, 49100
FranceSite Not Available
CHU Angers - Hôpital Hôtel Dieu
Angers, 49100
FranceActive - Recruiting
CHU Clermont-Ferrand - Hopital Gabriel Montpied
Clermont Ferrand, 63000
FranceSite Not Available
Cabinet Medical des Drs Prizac-Desbonnet Scottez
Douai, 59500
FranceSite Not Available
Hopital la Colombiere
Montpellier Cedex 5, 34295
FranceSite Not Available
CHU de Nantes hotel Dieu
Nantes, 44093
FranceSite Not Available
Cabinet De Psychiatrie Neurostim
Paris, 75005
FranceSite Not Available
Groupe Hospitalier Pitie-Salpetriere
Paris, 75013
FranceSite Not Available
Hopital Sainte Musse
Toulon, 83100
FranceSite Not Available
Universitaetsklinikum der RWTH Aachen
Aachen, 52074
GermanySite Not Available
Praxis Dr. med. Kirsten Hahn
Berlin, 13187
GermanySite Not Available
Vivantes Klinikum Spandau
Berlin, 13585
GermanySite Not Available
Universitaetsklinikum Frankfurt
Frankfurt, 60528
GermanySite Not Available
Universitatsklinikum Jena
Jena, 07743
GermanySite Not Available
Universitaetsklinikum Magdeburg A.oe.R
Magdeburg, 39120
GermanySite Not Available
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, 55131
GermanySite Not Available
Pharmakologisches Studienzentrum Chemnitz GmbH
Mittweida, 09648
GermanySite Not Available
Gemeinschaftspraxis Prof. Steinbach und Dr. Steib
Nuernberg, 90402
GermanySite Not Available
Praxis Kuehn
Oranienburg, 16515
GermanySite Not Available
Praxis Dipl.-med. Stefan Kusserow
Stralsund, 18439
GermanySite Not Available
ASL ROMA
Colleferro, 00034
ItalySite Not Available
Ospedale Policlinico San Martino IRCCS
Genova, 16132
ItalySite Not Available
AUSL LE di Lecce
Lecce, 73100
ItalySite Not Available
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora
Milano, 20122
ItalySite Not Available
Ospedale San Raffaele
Milano,
ItalySite Not Available
Azienda Ospedaliero Universitaria di Parma
Parma, 43125
ItalySite Not Available
Universita degli Studi di Perugia
Perugia, 06123
ItalySite Not Available
Policlinico Tor Vergata
Roma, 00133
ItalySite Not Available
University of Siena
Siena, 53100
ItalySite Not Available
Kyungpook National University Hospital
Daegu, 41944
Korea, Republic ofSite Not Available
CHA University ilsan Medical Center
Goyang, 10414
Korea, Republic ofSite Not Available
Gachon University Gil Medical Center
Incheon, 21565
Korea, Republic ofSite Not Available
Jeju National University Hospital
Jeju Special, 63241
Korea, Republic ofSite Not Available
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
Korea, Republic ofSite Not Available
Hallym University Kangdong Sacred Heart Hospital
Seoul, 05355
Korea, Republic ofSite Not Available
Kangbuk Samsung Hospital
Seoul, 03181
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Hosp Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08025
SpainSite Not Available
Hosp. Gral. de Villalba
Collado Villalba, 28400
SpainSite Not Available
Hosp. de Jerez de La Frontera
Jerez de la Frontera, 11407
SpainSite Not Available
Csm Fuencarral
Madrid, 28035
SpainSite Not Available
Hosp. Univ. Infanta Leonor
Madrid, 28031
SpainSite Not Available
Hosp Regional Univ de Malaga
Málaga, 29009
SpainSite Not Available
Hosp. Regional Univ. de Malaga
Málaga, 29009
SpainSite Not Available
Hosp. El Bierzo
Ponferrada, 24404
SpainSite Not Available
Hosp. Univ. I Politecni La Fe
Valencia, 46126
SpainSite Not Available
Hosp. Prov. de Zamora
Zamora, 49021
SpainSite Not Available
Gustavsbergs Vardcentral
Gustavsberg, 13440
SwedenSite Not Available
Affecta Pskyiatrimottagning
Halmstad, SE-30248
SwedenSite Not Available
ProbarE i Lund AB
Lund, 22222
SwedenSite Not Available
ONE LIFETIME Lakarmottagning
Skovde, SE-54150
SwedenSite Not Available
ONE LIFETIME Läkarmottagning
Skovde, SE-54150
SwedenActive - Recruiting
Abraham Cowley Unit
Chertsey, KT16 9AU
United KingdomSite Not Available
Kingsway Hospital
Derby, DE22 3LZ
United KingdomSite Not Available
Wonford House Hospital
Exeter, EX2 5AF
United KingdomSite Not Available
Kings College Hospital
London, SE5 8AF
United KingdomSite Not Available
Greater Manchester Mental Health NHSFT
Manchester, M25 3BL
United KingdomSite Not Available
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Newcastle upon Tyne, NE4 6BE
United KingdomSite Not Available
Lincolnshire Partnership NHS Foundation Trust (LPFT)
Sleaford, NG34 8GG
United KingdomSite Not Available
Moorgreen Hospital
Southampton, SO30 3JB
United KingdomSite Not Available
St George's Hospital
Stafford, ST16 3AG
United KingdomActive - Recruiting
St Georges Hospital
Stafford, ST16 3AG
United KingdomSite Not Available
South West Yorkshire Trust
Wakefield, WF1 3SP
United KingdomSite Not Available
University of Alabama at Birmingham
Birmingham, Alabama 35233
United StatesSite Not Available
University of Alabama at Birmingham
Homewood, Alabama 35209
United StatesSite Not Available
ATP Clinical Research
California City, California 92626
United StatesSite Not Available
University of Connecticut Health Center
Farmington, Connecticut 06030
United StatesSite Not Available
Flagler Hospital and Florida Center for TMS
Saint Augustine, Florida 32086
United StatesSite Not Available
Center for Revitalizing Psychiatry
Sarasota, Florida 34237
United StatesSite Not Available
Interventional Psychiatry of Tampa Bay
Tampa, Florida 33629
United StatesSite Not Available
Atlanta Behavioral Research, LLC
Atlanta, Georgia 30338
United StatesSite Not Available
Psych Atlanta, P.C.
Marietta, Georgia 30060
United StatesSite Not Available
University of Chicago
Chicago, Illinois 60637
United StatesSite Not Available
Loyola University Medical Center
Maywood, Illinois 60153
United StatesSite Not Available
Baber Research Group
Naperville, Illinois 60563
United StatesSite Not Available
Lumin Health
Newton, Massachusetts 02459
United StatesSite Not Available
Univeristy of Massachusetts
Worcester, Massachusetts 01605-2610
United StatesSite Not Available
Missouri University Health Care South Providence Psychiatry
Columbia, Missouri 65201
United StatesSite Not Available
Signature Research Associates Inc.
Fairlawn, Ohio 44333
United StatesSite Not Available
Lehigh Center for Clinical Research
Allentown, Pennsylvania 18104
United StatesSite Not Available
Seattle Neuropsychiatric Treatment Center
Tacoma, Washington 98405-1954
United StatesSite Not Available
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