A Study in Participants With Major Depressive Disorder (MDD) With Anhedonia and Inadequate Response to Current Antidepressant Therapy Including a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI)

Last updated: April 2, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Treatment

No Intervention

Clinical Study ID

NCT05841030
CR109332
67953964MDD3004
  • Ages 18-74
  • All Genders

Study Summary

The purpose of this study is to assess the socio-demographic, disease-related and treatment-related characteristics, and the standard of care (SOC) treatment patterns of participants with major depressive disorder (MDD) with anhedonia with inadequate response to their current antidepressant treatments and treated according to the standard of care treatment.

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

Total Participants: 500
Treatment Group(s): 1
Primary Treatment: No Intervention
Phase:
Study Start date:
April 28, 2023
Estimated Completion Date:
November 21, 2025

Connect with a study center

  • Hospital Fleni

    Ciudad Autonoma Buenos Aires, C1428AQK
    Argentina

    Active - Recruiting

  • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

    Ciudad Autonoma de Buenos Aires, C1133AAH
    Argentina

    Active - Recruiting

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma de Buenos Aires, C1181ACH
    Argentina

    Active - Recruiting

  • Resolution

    Ciudad de Mendoza, M5502AHV
    Argentina

    Active - Recruiting

  • CEN Consultorios Especializados en Neurociencias

    Cordoba, 5000FJF
    Argentina

    Active - Recruiting

  • CEN-Consultorios Especializados en Neurociencias

    Cordoba, 5000FJF
    Argentina

    Active - Recruiting

  • Centro Medico Luquez

    Cordoba, X5006IKK
    Argentina

    Active - Recruiting

  • Instituto Medico DAMIC

    Cordoba, X5003DCE
    Argentina

    Active - Recruiting

  • Hospital Sao Vicente de Paulo

    Passo Fundo, 99010-080
    Brazil

    Active - Recruiting

  • Centro Integrado Facili

    Sao Bernardo do Campo, 09726 150
    Brazil

    Active - Recruiting

  • Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto

    Sao Jose Rio Preto, 15090-000
    Brazil

    Active - Recruiting

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

    Sao Jose Rio Preto, 15090 000
    Brazil

    Active - Recruiting

  • Clinica Viver - Centro de Desospitalizacao Humana

    Sao Paulo, 04020-060
    Brazil

    Active - Recruiting

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    Sao Paulo, 05403-000
    Brazil

    Active - Recruiting

  • The Medical Arts Health Research Group

    West Vancouver, British Columbia V7T 1C5
    Canada

    Terminated

  • Providence Care Hospital

    Kingston, Ontario K7L 4X3
    Canada

    Active - Recruiting

  • Jodha Tishon Inc.

    Toronto, Ontario M5S 3A3
    Canada

    Terminated

  • St. Michael's Hospital

    Toronto, Ontario M5B 1W8
    Canada

    Active - Recruiting

  • Introspect Clinic

    Ontario, K1C 1E9
    Canada

    Active - Recruiting

  • CHU Angers - Hopital Hotel Dieu

    Angers, 49100
    France

    Active - Recruiting

  • CHU Angers - Hôpital Hôtel Dieu

    Angers, 49100
    France

    Active - Recruiting

  • CHU Clermont-Ferrand - Hopital Gabriel Montpied

    Clermont Ferrand, 63000
    France

    Active - Recruiting

  • Cabinet Medical des Drs Prizac-Desbonnet Scottez

    Douai, 59500
    France

    Active - Recruiting

  • Hopital la Colombiere

    Montpellier Cedex 5, 34295
    France

    Active - Recruiting

  • CHU de Nantes hotel Dieu

    Nantes, 44093
    France

    Active - Recruiting

  • Cabinet De Psychiatrie Neurostim

    Paris, 75005
    France

    Active - Recruiting

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013
    France

    Active - Recruiting

  • Universitaetsklinikum der RWTH Aachen

    Aachen, 52074
    Germany

    Active - Recruiting

  • Praxis Dr. med. Kirsten Hahn

    Berlin, 13187
    Germany

    Active - Recruiting

  • Vivantes Klinikum Spandau

    Berlin, 13585
    Germany

    Active - Recruiting

  • Universitaetsklinikum Frankfurt

    Frankfurt, 60528
    Germany

    Active - Recruiting

  • Universitatsklinikum Jena

    Jena, 07743
    Germany

    Active - Recruiting

  • Universitaetsklinikum Magdeburg A.oe.R

    Magdeburg, 39120
    Germany

    Site Not Available

  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz

    Mainz, 55131
    Germany

    Active - Recruiting

  • Pharmakologisches Studienzentrum Chemnitz GmbH

    Mittweida, 09648
    Germany

    Active - Recruiting

  • Gemeinschaftspraxis Prof. Steinbach und Dr. Steib

    Nuernberg, 90402
    Germany

    Active - Recruiting

  • Praxis Kuehn

    Oranienburg, 16515
    Germany

    Terminated

  • Praxis Dipl.-med. Stefan Kusserow

    Stralsund, 18439
    Germany

    Active - Recruiting

  • ASL ROMA

    Colleferro, 00034
    Italy

    Active - Recruiting

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132
    Italy

    Active - Recruiting

  • AUSL LE di Lecce

    Lecce, 73100
    Italy

    Active - Recruiting

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora

    Milano, 20122
    Italy

    Active - Recruiting

  • Ospedale San Raffaele

    Milano,
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43125
    Italy

    Active - Recruiting

  • Universita degli Studi di Perugia

    Perugia, 06123
    Italy

    Active - Recruiting

  • Policlinico Tor Vergata

    Roma, 00133
    Italy

    Active - Recruiting

  • University of Siena

    Siena, 53100
    Italy

    Active - Recruiting

  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

    Completed

  • CHA University ilsan Medical Center

    Goyang, 10414
    Korea, Republic of

    Active - Recruiting

  • Gachon University Gil Medical Center

    Incheon, 21565
    Korea, Republic of

    Active - Recruiting

  • Jeju National University Hospital

    Jeju Special, 63241
    Korea, Republic of

    Active - Recruiting

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273
    Korea, Republic of

    Active - Recruiting

  • Hallym University Kangdong Sacred Heart Hospital

    Seoul, 05355
    Korea, Republic of

    Active - Recruiting

  • Kangbuk Samsung Hospital

    Seoul, 03181
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Hosp Clinic de Barcelona

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025
    Spain

    Active - Recruiting

  • Hosp. Gral. de Villalba

    Collado Villalba, 28400
    Spain

    Active - Recruiting

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407
    Spain

    Active - Recruiting

  • Csm Fuencarral

    Madrid, 28035
    Spain

    Active - Recruiting

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031
    Spain

    Active - Recruiting

  • Hosp Regional Univ de Malaga

    Málaga, 29009
    Spain

    Active - Recruiting

  • Hosp. Regional Univ. de Malaga

    Málaga, 29009
    Spain

    Site Not Available

  • Hosp. El Bierzo

    Ponferrada, 24404
    Spain

    Active - Recruiting

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46126
    Spain

    Active - Recruiting

  • Hosp. Prov. de Zamora

    Zamora, 49021
    Spain

    Active - Recruiting

  • Gustavsbergs Vardcentral

    Gustavsberg, 13440
    Sweden

    Active - Recruiting

  • Affecta Pskyiatrimottagning

    Halmstad, SE-30248
    Sweden

    Active - Recruiting

  • ProbarE i Lund AB

    Lund, 22222
    Sweden

    Active - Recruiting

  • ONE LIFETIME Lakarmottagning

    Skovde, SE-54150
    Sweden

    Active - Recruiting

  • ONE LIFETIME Läkarmottagning

    Skovde, SE-54150
    Sweden

    Active - Recruiting

  • Abraham Cowley Unit

    Chertsey, KT16 9AU
    United Kingdom

    Active - Recruiting

  • Kingsway Hospital

    Derby, DE22 3LZ
    United Kingdom

    Active - Recruiting

  • Wonford House Hospital

    Exeter, EX2 5AF
    United Kingdom

    Active - Recruiting

  • Kings College Hospital

    London, SE5 8AF
    United Kingdom

    Active - Recruiting

  • Greater Manchester Mental Health NHSFT

    Manchester, M25 3BL
    United Kingdom

    Active - Recruiting

  • Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

    Newcastle upon Tyne, NE4 6BE
    United Kingdom

    Active - Recruiting

  • Lincolnshire Partnership NHS Foundation Trust (LPFT)

    Sleaford, NG34 8GG
    United Kingdom

    Active - Recruiting

  • Moorgreen Hospital

    Southampton, SO30 3JB
    United Kingdom

    Active - Recruiting

  • St George's Hospital

    Stafford, ST16 3AG
    United Kingdom

    Active - Recruiting

  • South West Yorkshire Trust

    Wakefield, WF1 3SP
    United Kingdom

    Active - Recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • University of Alabama at Birmingham

    Homewood, Alabama 35209
    United States

    Active - Recruiting

  • ATP Clinical Research

    California City, California 92626
    United States

    Active - Recruiting

  • University of Connecticut Health Center

    Farmington, Connecticut 06030
    United States

    Active - Recruiting

  • Flagler Hospital and Florida Center for TMS

    Saint Augustine, Florida 32086
    United States

    Active - Recruiting

  • Center for Revitalizing Psychiatry

    Sarasota, Florida 34237
    United States

    Active - Recruiting

  • Interventional Psychiatry of Tampa Bay

    Tampa, Florida 33629
    United States

    Active - Recruiting

  • Atlanta Behavioral Research, LLC

    Atlanta, Georgia 30338
    United States

    Active - Recruiting

  • Psych Atlanta, P.C.

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • University of Chicago

    Chicago, Illinois 60637
    United States

    Active - Recruiting

  • Loyola University Medical Center

    Maywood, Illinois 60153
    United States

    Active - Recruiting

  • Baber Research Group

    Naperville, Illinois 60563
    United States

    Active - Recruiting

  • Lumin Health

    Newton, Massachusetts 02459
    United States

    Active - Recruiting

  • Univeristy of Massachusetts

    Worcester, Massachusetts 01605-2610
    United States

    Terminated

  • Missouri University Health Care South Providence Psychiatry

    Columbia, Missouri 65201
    United States

    Active - Recruiting

  • Signature Research Associates Inc.

    Fairlawn, Ohio 44333
    United States

    Active - Recruiting

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania 18104
    United States

    Active - Recruiting

  • Seattle Neuropsychiatric Treatment Center

    Tacoma, Washington 98405-1954
    United States

    Active - Recruiting

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