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New study maps Real-Life treatment for depression with anhedonia

NCT ID NCT05841030

Knowledge-focused Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 545 people with major depressive disorder who also have anhedonia (loss of interest or pleasure) and whose current antidepressants weren't working well enough. Researchers tracked their symptoms, treatments, and outcomes to better understand the disease and how doctors manage it in real life. The goal was to gather information, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

545 people

The number who actually took part.

Started

Apr 2023

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depressive disorder, major

Contacts and locations

Locations

  • ASL ROMA

    Colleferro, 00034, Italy

  • ATP Clinical Research

    California City, California, 92626, United States

  • AUSL LE di Lecce

    Lecce, 73100, Italy

  • Abraham Cowley Unit

    Chertsey, KT16 9AU, United Kingdom

  • Affecta Pskyiatrimottagning

    Halmstad, SE-30248, Sweden

  • Atlanta Behavioral Research, LLC

    Atlanta, Georgia, 30338, United States

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43125, Italy

  • Baber Research Group

    Naperville, Illinois, 60563, United States

  • CEN Consultorios Especializados en Neurociencias

    Córdoba, 5000FJF, Argentina

  • CHA University ilsan Medical Center

    Goyang, 10414, South Korea

  • CHU Angers - Hopital Hotel Dieu

    Angers, 49100, France

  • CHU Clermont-Ferrand - Hopital Gabriel Montpied

    Clermont-Ferrand, 63000, France

  • CHU de Grenoble - Hôpital Sud

    Isere, 38043, France

  • CHU de Nantes hotel Dieu

    Nantes, 44093, France

  • Cabinet De Psychiatrie Neurostim

    Paris, 75005, France

  • Cabinet Medical des Drs Prizac-Desbonnet Scottez

    Douai, 59500, France

  • Center for Revitalizing Psychiatry

    Sarasota, Florida, 34237, United States

  • Centro Integrado Facili

    São Bernardo do Campo, 09726 150, Brazil

  • Centro Medico Luquez

    Córdoba, X5006IKK, Argentina

  • Clinica Viver - Centro de Desospitalizacao Humana

    São Paulo, 04020-060, Brazil

  • Csm Fuencarral

    Madrid, 28035, Spain

  • Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

    Newcastle upon Tyne, NE4 6BE, United Kingdom

  • Flagler Hospital and Florida Center for TMS

    Saint Augustine, Florida, 32086, United States

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

    Milan, 20122, Italy

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

    Sao Jose Rio Preto, 15090 000, Brazil

  • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

    Buenos Aires, C1133AAH, Argentina

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273, South Korea

  • Gemeinschaftspraxis Prof. Steinbach und Dr. Steib

    Nuremberg, 90402, Germany

  • Greater Manchester Mental Health NHSFT

    Manchester, M25 3BL, United Kingdom

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013, France

  • Gustavsbergs Vardcentral

    Gustavsberg, 13440, Sweden

  • Hallym University Kangdong Sacred Heart Hospital

    Seoul, 05355, South Korea

  • Hopital Sainte Musse

    Toulon, 83100, France

  • Hopital la Colombiere

    Montpellier, 34295, France

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Regional Univ de Malaga

    Málaga, 29009, Spain

  • Hosp. El Bierzo

    Ponferrada, 24404, Spain

  • Hosp. Gral. de Villalba

    Collado Villalba, 28400, Spain

  • Hosp. Prov. de Zamora

    Zamora, 49021, Spain

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46126, Spain

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031, Spain

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407, Spain

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025, Spain

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403-000, Brazil

  • Hospital Fleni

    Ciudad Autonoma Buenos Aires, C1428AQK, Argentina

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH, Argentina

  • Hospital Sao Vicente de Paulo

    Passo Fundo, 99010-080, Brazil

  • Instituto Medico DAMIC

    Córdoba, X5003DCE, Argentina

  • Interventional Psychiatry of Tampa Bay

    Tampa, Florida, 33629, United States

  • Introspect Clinic

    Ontario, Ontario, K1C 1E9, Canada

  • Jeju National University Hospital

    Jeju Special, 63241, South Korea

  • Jodha Tishon Inc.

    Toronto, Ontario, M5S 3A3, Canada

  • Kangbuk Samsung Hospital

    Seoul, 03181, South Korea

  • Kings College Hospital

    London, SE5 8AF, United Kingdom

  • Kingsway Hospital

    Derby, DE22 3LZ, United Kingdom

  • Kyungpook National University Hospital

    Daegu, 41944, South Korea

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104, United States

  • Lincolnshire Partnership NHS Foundation Trust (LPFT)

    Sleaford, NG34 8GG, United Kingdom

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Lumin Health

    Newton, Massachusetts, 02459, United States

  • Missouri University Health Care South Providence Psychiatry

    Columbia, Missouri, 65201, United States

  • Moorgreen Hospital

    Southampton, SO30 3JB, United Kingdom

  • ONE LIFETIME Lakarmottagning

    Skövde, SE-54150, Sweden

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132, Italy

  • Ospedale San Raffaele

    Milan, Italy

  • Pharmakologisches Studienzentrum Chemnitz GmbH

    Mittweida, 09648, Germany

  • Policlinico Tor Vergata

    Roma, 00133, Italy

  • Praxis Dipl.-med. Stefan Kusserow

    Stralsund, 18439, Germany

  • Praxis Dr. med. Kirsten Hahn

    Berlin, 13187, Germany

  • Praxis Kuehn

    Oranienburg, 16515, Germany

  • ProbarE i Lund AB

    Lund, 22222, Sweden

  • Providence Care Hospital

    Kingston, Ontario, K7L 4X3, Canada

  • Psych Atlanta, P.C.

    Marietta, Georgia, 30060, United States

  • Resolution

    Mendoza, M5502AHV, Argentina

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seattle Neuropsychiatric Treatment Center

    Tacoma, Washington, 98405-1954, United States

  • Signature Research Associates Inc.

    Fairlawn, Ohio, 44333, United States

  • South West Yorkshire Trust

    Wakefield, WF1 3SP, United Kingdom

  • St Georges Hospital

    Stafford, ST16 3AG, United Kingdom

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • The Medical Arts Health Research Group

    West Vancouver, British Columbia, V7T 1C5, Canada

  • Univeristy of Massachusetts

    Worcester, Massachusetts, 01605-2610, United States

  • Universita degli Studi di Perugia

    Perugia, 06123, Italy

  • Universitaetsklinikum Frankfurt

    Frankfurt, 60528, Germany

  • Universitaetsklinikum der RWTH Aachen

    Aachen, 52074, Germany

  • Universitatsklinikum Jena

    Jena, 07743, Germany

  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz

    Mainz, 55131, Germany

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Alabama at Birmingham 1

    Homewood, Alabama, 35209, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030, United States

  • University of Siena

    Siena, 53100, Italy

  • Vivantes Klinikum Spandau

    Berlin, 13585, Germany

  • Wonford House Hospital

    Exeter, EX2 5AF, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.