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)
NCT ID: NCT05841030
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
544 participants
OBSERVATIONAL
2023-04-28
2025-11-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MDD Participants With Anhedonia
Data will be collected, for major depressive disorder (MDD) participants with anhedonia who have had an inadequate response to a standard of care (SOC) antidepressant treatment, from participant's source medical records from routine clinical practice over a period of 12 months.
No Intervention
There is no interventional treatment administered to the participants as a part of this study.
Interventions
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No Intervention
There is no interventional treatment administered to the participants as a part of this study.
Eligibility Criteria
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Inclusion Criteria
* Is considered to suffer from a moderate or severe depressive syndrome, as defined by a Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to (\>=) 22 at entry
* Is initiating or is planning to initiate a new add-on antidepressant treatment per local prescribing information to treat the current depressive episode. In the context of this observational study, a new add-on antidepressant treatment is considered any new pharmacological or non-pharmacological treatment that is prescribed in addition to the current antidepressant treatment, inclusive of an selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI or SNRI) with the intent to improve a participant's clinical depressive syndrome. Accordingly, any dose escalation of an antidepressant prescribed prior to baseline or the addition of any drug intended to increase the plasma-concentration of an antidepressant prescribed prior to baseline is not considered a new antidepressant treatment; In parallel with the inclusion of participants considered for add-on strategy, in the United States only, a cohort of approximately 50 participants who switch to a new single (monotherapy) pharmacological antidepressant agent of any antidepressant class per local prescribing information to replace the current antidepressant treatment (that is, "monotherapy switch strategy") will be enrolled. The enrollment of participants with switch to monotherapy will be monitored, and sites will be notified by the sponsor once the planned number for the cohort 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 legally acceptable representative) an informed consent form indicating that he or she understands the purpose of the study and that he or she agrees to have their data collected and analyzed, in accordance with local requirements and the study protocol
* Meets the criterion for inadequate response to a current antidepressant treatment that includes an SSRI or SNRI (monotherapy SSRI, monotherapy SNRI, combination of antidepressants that includes SSRI/SNRI or SSRI/SNRI augmentation), administered at an adequate dose (as defined in the Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire \[MGH ATRQ\]) and duration (at least 6 weeks) in the current episode of depression
Exclusion Criteria
* Participants who require an antidepressant (SSRI/SNRI) change (switch to another antidepressant monotherapy), except for a limited number of participants to be recruited in the United States only
* Unstable general medical condition (for example, cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic, or endocrine disorders) in the past 3 months that would compromise participation and normal routine medical care per the physician's clinical judgment
* Has lack of treatment response to the current antidepressant therapy that includes a SSRI/SNRI (that is, no \[0%\] symptomatic improvement despite adequate dose and duration of the antidepressant treatment) assessed using the MGH ATRQ
* History of dementia or mild cognitive impairment. Physician's clinical judgment should document that participant is capable of complying with observational study requirements and being able to complete the appropriate scales
* Has homicidal ideation/intent or is at imminent risk of suicide per the physician's clinical judgment and/or based on the Columbia Suicide Severity Rating Scale (C-SSRS) corresponding to a response of "Yes" on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent)
18 Years
74 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Alabama at Birmingham
Homewood, Alabama, United States
ATP Clinical Research
California City, California, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Flagler Hospital and Florida Center for TMS
Saint Augustine, Florida, United States
Center for Revitalizing Psychiatry
Sarasota, Florida, United States
Interventional Psychiatry of Tampa Bay
Tampa, Florida, United States
Atlanta Behavioral Research, LLC
Atlanta, Georgia, United States
Psych Atlanta, P.C.
Marietta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Baber Research Group
Naperville, Illinois, United States
Lumin Health
Newton, Massachusetts, United States
Univeristy of Massachusetts
Worcester, Massachusetts, United States
Missouri University Health Care South Providence Psychiatry
Columbia, Missouri, United States
Signature Research Associates Inc.
Fairlawn, Ohio, United States
Lehigh Center for Clinical Research
Allentown, Pennsylvania, United States
Seattle Neuropsychiatric Treatment Center
Tacoma, Washington, United States
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
Buenos Aires, , Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Hospital Fleni
Ciudad Autonoma Buenos Aires, , Argentina
CEN Consultorios Especializados en Neurociencias
Córdoba, , Argentina
Instituto Medico DAMIC
Córdoba, , Argentina
Centro Medico Luquez
Córdoba, , Argentina
Resolution
Mendoza, , Argentina
Hospital Sao Vicente de Paulo
Passo Fundo, , Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
Sao Jose Rio Preto, , Brazil
Centro Integrado Facili
São Bernardo do Campo, , Brazil
Clinica Viver - Centro de Desospitalizacao Humana
São Paulo, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, , Brazil
The Medical Arts Health Research Group
West Vancouver, British Columbia, Canada
Providence Care Hospital
Kingston, Ontario, Canada
Introspect Clinic
Ontario, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Jodha Tishon Inc.
Toronto, Ontario, Canada
CHU Angers - Hopital Hotel Dieu
Angers, , France
CHU Clermont-Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, , France
Cabinet Medical des Drs Prizac-Desbonnet Scottez
Douai, , France
CHU de Grenoble - Hôpital Sud
Isere, , France
Hopital la Colombiere
Montpellier, , France
CHU de Nantes hotel Dieu
Nantes, , France
Cabinet De Psychiatrie Neurostim
Paris, , France
Groupe Hospitalier Pitie-Salpetriere
Paris, , France
Hopital Sainte Musse
Toulon, , France
Universitaetsklinikum der RWTH Aachen
Aachen, , Germany
Praxis Dr. med. Kirsten Hahn
Berlin, , Germany
Vivantes Klinikum Spandau
Berlin, , Germany
Universitaetsklinikum Frankfurt
Frankfurt, , Germany
Universitatsklinikum Jena
Jena, , Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
Mainz, , Germany
Pharmakologisches Studienzentrum Chemnitz GmbH
Mittweida, , Germany
Gemeinschaftspraxis Prof. Steinbach und Dr. Steib
Nuremberg, , Germany
Praxis Kuehn
Oranienburg, , Germany
Praxis Dipl.-med. Stefan Kusserow
Stralsund, , Germany
ASL ROMA
Colleferro, , Italy
Ospedale Policlinico San Martino IRCCS
Genova, , Italy
AUSL LE di Lecce
Lecce, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora
Milan, , Italy
Ospedale San Raffaele
Milan, , Italy
Azienda Ospedaliero Universitaria di Parma
Parma, , Italy
Universita degli Studi di Perugia
Perugia, , Italy
Policlinico Tor Vergata
Roma, , Italy
University of Siena
Siena, , Italy
Kyungpook National University Hospital
Daegu, , South Korea
CHA University ilsan Medical Center
Goyang, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Jeju National University Hospital
Jeju Special, , South Korea
Kangbuk Samsung Hospital
Seoul, , South Korea
Hallym University Kangdong Sacred Heart Hospital
Seoul, , South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hosp. de La Santa Creu I Sant Pau
Barcelona, , Spain
Hosp Clinic de Barcelona
Barcelona, , Spain
Hosp. Gral. de Villalba
Collado Villalba, , Spain
Hosp. de Jerez de La Frontera
Jerez de la Frontera, , Spain
Hosp. Univ. Infanta Leonor
Madrid, , Spain
Csm Fuencarral
Madrid, , Spain
Hosp Regional Univ de Malaga
Málaga, , Spain
Hosp. El Bierzo
Ponferrada, , Spain
Hosp. Univ. I Politecni La Fe
Valencia, , Spain
Hosp. Prov. de Zamora
Zamora, , Spain
Gustavsbergs Vardcentral
Gustavsberg, , Sweden
Affecta Pskyiatrimottagning
Halmstad, , Sweden
ProbarE i Lund AB
Lund, , Sweden
ONE LIFETIME Lakarmottagning
Skövde, , Sweden
Abraham Cowley Unit
Chertsey, , United Kingdom
Kingsway Hospital
Derby, , United Kingdom
Wonford House Hospital
Exeter, , United Kingdom
Kings College Hospital
London, , United Kingdom
Greater Manchester Mental Health NHSFT
Manchester, , United Kingdom
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Lincolnshire Partnership NHS Foundation Trust (LPFT)
Sleaford, , United Kingdom
Moorgreen Hospital
Southampton, , United Kingdom
St Georges Hospital
Stafford, , United Kingdom
South West Yorkshire Trust
Wakefield, , United Kingdom
Countries
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Other Identifiers
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67953964MDD3004
Identifier Type: OTHER
Identifier Source: secondary_id
CR109332
Identifier Type: -
Identifier Source: org_study_id