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)

NCT05841030 | Completed FDA Drug

• 2 other identifiers: CR10933267953964MDD3004
• Study Type: observational
• Target: 545
• Locations: 11 countries
• Sites: 95

Brief 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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (7)

• Percentage of Participants With Different Socio-demographic Characteristics

  Distribution of participants with different demographic characteristics will be assessed.

  Day 1

• Percentage of Participants with Disease-related Characteristics

  Percentage of participants with disease-related characteristics which includes diagnosis/ disease history and psychiatric/ general medical comorbidities, will be reported.

  Day 1

• Percentage of Participants With Type of Therapies and Treatment Strategies

  Percentage of participants with type of therapies (such as augmentation, combination therapy, etc.) and treatment strategies will be reported.

  Day 1

• Time to Next Antidepressant Treatment

  Time to next antidepressant treatment will be reported.

  Up to 12 months

• Percentage of Participants with Recurrence or Relapse

  Percentage of participants with recurrence or relapse will be reported.

  Up to 12 months

• Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score

  Change from baseline in CSFQ-14 total score will be reported. The CSFQ-14 is a structured, self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items). Each question rated on a 5-point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning.

  Baseline, up to 12 months

• Percentage of Participants With Patient Global Impression of Severity (PGI-S) Scale Score for Sexual Functioning

  Percentage of participants with PGI-S scale score for sexual functioning will be reported. The PGI-S is a self-administered, single item questionnaire measuring patients' impression of disease severity. Participants will be asked to rate their disease severity using the following 5-point scale: 1 = None, 2 = Mild, 3 = Moderate, 4 = Severe, and 5 = Very severe. Higher scores indicate greater disease severity.

  Up to 12 months

Study Arms (1)

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.

Other: No Intervention

Interventions

No Intervention OTHER

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

MDD Participants With Anhedonia

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consists of participants with MDD with anhedonia who have had an inadequate response to an antidepressant.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (95)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of Alabama at Birmingham 1

Homewood, Alabama, 35209, United States

Location

ATP Clinical Research

California City, California, 92626, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Flagler Hospital and Florida Center for TMS

Saint Augustine, Florida, 32086, United States

Location

Center for Revitalizing Psychiatry

Sarasota, Florida, 34237, United States

Location

Interventional Psychiatry of Tampa Bay

Tampa, Florida, 33629, United States

Location

Atlanta Behavioral Research, LLC

Atlanta, Georgia, 30338, United States

Location

Psych Atlanta, P.C.

Marietta, Georgia, 30060, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Baber Research Group

Naperville, Illinois, 60563, United States

Location

Lumin Health

Newton, Massachusetts, 02459, United States

Location

Univeristy of Massachusetts

Worcester, Massachusetts, 01605-2610, United States

Location

Missouri University Health Care South Providence Psychiatry

Columbia, Missouri, 65201, United States

Location

Signature Research Associates Inc.

Fairlawn, Ohio, 44333, United States

Location

Lehigh Center for Clinical Research

Allentown, Pennsylvania, 18104, United States

Location

Seattle Neuropsychiatric Treatment Center

Tacoma, Washington, 98405-1954, United States

Location

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

Buenos Aires, C1133AAH, Argentina

Location

Hospital Italiano de Buenos Aires

Buenos Aires, C1181ACH, Argentina

Location

Hospital Fleni

Ciudad Autonoma Buenos Aires, C1428AQK, Argentina

Location

CEN Consultorios Especializados en Neurociencias

Córdoba, 5000FJF, Argentina

Location

Instituto Medico DAMIC

Córdoba, X5003DCE, Argentina

Location

Centro Medico Luquez

Córdoba, X5006IKK, Argentina

Location

Resolution

Mendoza, M5502AHV, Argentina

Location

Hospital Sao Vicente de Paulo

Passo Fundo, 99010-080, Brazil

Location

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

Sao Jose Rio Preto, 15090 000, Brazil

Location

Centro Integrado Facili

São Bernardo do Campo, 09726 150, Brazil

Location

Clinica Viver - Centro de Desospitalizacao Humana

São Paulo, 04020-060, Brazil

Location

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, 05403-000, Brazil

Location

The Medical Arts Health Research Group

West Vancouver, British Columbia, V7T 1C5, Canada

Location

Providence Care Hospital

Kingston, Ontario, K7L 4X3, Canada

Location

Introspect Clinic

Ontario, Ontario, K1C 1E9, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Jodha Tishon Inc.

Toronto, Ontario, M5S 3A3, Canada

Location

CHU Angers - Hopital Hotel Dieu

Angers, 49100, France

Location

CHU Clermont-Ferrand - Hopital Gabriel Montpied

Clermont-Ferrand, 63000, France

Location

Cabinet Medical des Drs Prizac-Desbonnet Scottez

Douai, 59500, France

Location

CHU de Grenoble - Hôpital Sud

Isere, 38043, France

Location

Hopital la Colombiere

Montpellier, 34295, France

Location

CHU de Nantes hotel Dieu

Nantes, 44093, France

Location

Cabinet De Psychiatrie Neurostim

Paris, 75005, France

Location

Groupe Hospitalier Pitie-Salpetriere

Paris, 75013, France

Location

Hopital Sainte Musse

Toulon, 83100, France

Location

Universitaetsklinikum der RWTH Aachen

Aachen, 52074, Germany

Location

Praxis Dr. med. Kirsten Hahn

Berlin, 13187, Germany

Location

Vivantes Klinikum Spandau

Berlin, 13585, Germany

Location

Universitaetsklinikum Frankfurt

Frankfurt, 60528, Germany

Location

Universitatsklinikum Jena

Jena, 07743, Germany

Location

Universitatsmedizin der Johannes Gutenberg Universitat Mainz

Mainz, 55131, Germany

Location

Pharmakologisches Studienzentrum Chemnitz GmbH

Mittweida, 09648, Germany

Location

Gemeinschaftspraxis Prof. Steinbach und Dr. Steib

Nuremberg, 90402, Germany

Location

Praxis Kuehn

Oranienburg, 16515, Germany

Location

Praxis Dipl.-med. Stefan Kusserow

Stralsund, 18439, Germany

Location

ASL ROMA

Colleferro, 00034, Italy

Location

Ospedale Policlinico San Martino IRCCS

Genova, 16132, Italy

Location

AUSL LE di Lecce

Lecce, 73100, Italy

Location

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora

Milan, 20122, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

Azienda Ospedaliero Universitaria di Parma

Parma, 43125, Italy

Location

Universita degli Studi di Perugia

Perugia, 06123, Italy

Location

Policlinico Tor Vergata

Roma, 00133, Italy

Location

University of Siena

Siena, 53100, Italy

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

CHA University ilsan Medical Center

Goyang, 10414, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Jeju National University Hospital

Jeju Special, 63241, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

Hallym University Kangdong Sacred Heart Hospital

Seoul, 05355, South Korea

Location

Gangnam Severance Hospital, Yonsei University Health System

Seoul, 06273, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hosp. de La Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hosp. Gral. de Villalba

Collado Villalba, 28400, Spain

Location

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407, Spain

Location

Hosp. Univ. Infanta Leonor

Madrid, 28031, Spain

Location

Csm Fuencarral

Madrid, 28035, Spain

Location

Hosp Regional Univ de Malaga

Málaga, 29009, Spain

Location

Hosp. El Bierzo

Ponferrada, 24404, Spain

Location

Hosp. Univ. I Politecni La Fe

Valencia, 46126, Spain

Location

Hosp. Prov. de Zamora

Zamora, 49021, Spain

Location

Gustavsbergs Vardcentral

Gustavsberg, 13440, Sweden

Location

Affecta Pskyiatrimottagning

Halmstad, SE-30248, Sweden

Location

ProbarE i Lund AB

Lund, 22222, Sweden

Location

ONE LIFETIME Lakarmottagning

Skövde, SE-54150, Sweden

Location

Abraham Cowley Unit

Chertsey, KT16 9AU, United Kingdom

Location

Kingsway Hospital

Derby, DE22 3LZ, United Kingdom

Location

Wonford House Hospital

Exeter, EX2 5AF, United Kingdom

Location

Kings College Hospital

London, SE5 8AF, United Kingdom

Location

Greater Manchester Mental Health NHSFT

Manchester, M25 3BL, United Kingdom

Location

Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

Newcastle upon Tyne, NE4 6BE, United Kingdom

Location

Lincolnshire Partnership NHS Foundation Trust (LPFT)

Sleaford, NG34 8GG, United Kingdom

Location

Moorgreen Hospital

Southampton, SO30 3JB, United Kingdom

Location

St Georges Hospital

Stafford, ST16 3AG, United Kingdom

Location

South West Yorkshire Trust

Wakefield, WF1 3SP, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 3, 2023
• Study Start: April 28, 2023
• Primary Completion: February 27, 2026
• Study Completion: February 27, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (9); KR (8); AR (7); ES (10); SE (4); CA (5); DE (10); US (18); GB (10); FR (9); BR (5)