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NCT05841030

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)

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

Official title: A Study of Disease Characteristics and Real-life Standard of Care Effectiveness in Patients With Major Depressive Disorder (MDD) With Anhedonia and Inadequate Response to Current Antidepressant Therapy Including an SSRI or SNRI

Key Details

Gender

All

Age Range

18 Years - 74 Years

Study Type

OBSERVATIONAL

Enrollment

545

Start Date

2023-04-28

Completion Date

2026-03-13

Last Updated

2026-03-12

Healthy Volunteers

Conditions

Depressive Disorder, Major

Interventions

OTHER

No Intervention

There is no interventional treatment administered to the participants as a part of this study.

Inclusion Criteria: * Meets the diagnostic criteria for single episode or recurrent major depressive disorder (MDD) without psychotic features, according to either the tenth revision of the 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 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: * Has a current or prior diagnosis of a psychotic disorder, MDD with psychotic features, bipolar or related disorders or intellectual disability, according to DSM-5 or ICD-10 * 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)

Locations (95)

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

Clinical Research Directory

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)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (95)