NCT05841030Completed
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)
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
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 545 (actual)
- First submitted
- 24 Apr 2023
- Start date
- 28 Apr 2023
- Primary completion date
- 27 Feb 2026
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Depression
- NCT number
- NCT05841030
What you commit to
- Study type: Observational
- Participants enrolled: 545
- From 28 Apr 2023 to the primary completion date, 27 Feb 2026
- 95 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- 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
- 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
Other
- 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
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to 74 years · Sex: All · Does not accept healthy volunteers
Sites (95)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Italiano de Buenos Aires Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital Fleni Coordinator of this site? Confirm its status | Ciudad Autonoma Buenos Aires | Argentina | Unknown status |
| Centro Médico Luquez Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Instituto Médico DAMIC Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| CEN Consultorios Especializados en Neurociencias Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Resolution Coordinator of this site? Confirm its status | Mendoza | Argentina | Unknown status |
| Hospital São Vicente de Paulo Coordinator of this site? Confirm its status | Passo Fundo | Brazil | Unknown status |
| Centro Integrado Facili Coordinator of this site? Confirm its status | São Bernardo do Campo | Brazil | Unknown status |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base Coordinator of this site? Confirm its status | Sao Jose Rio Preto | Brazil | Unknown status |
| Hospital das Clinicas da Faculdade de Medicina da USP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Clinica Viver - Centro de Desospitalizacao Humana Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Providence care Hospital Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
| Introspect Clinic Coordinator of this site? Confirm its status | Ontario | Canada | Unknown status |
| Jodha Tishon Inc. Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| St. Michael's Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| The Medical Arts Health Research Group Coordinator of this site? Confirm its status | West Vancouver | Canada | Unknown status |
| Universitaetsklinikum der RWTH Aachen Coordinator of this site? Confirm its status | Aachen | Germany | Unknown status |
| Praxis Dr. med. Kirsten Hahn Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Vivantes Klinikum Spandau Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Universitaetsklinikum Frankfurt Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Universitätsklinikum Jena Coordinator of this site? Confirm its status | Jena | Germany | Unknown status |
| Universitätsmedizin der Johannes Gutenberg-Universität Mainz Coordinator of this site? Confirm its status | Mainz | Germany | Unknown status |
| Pharmakologisches Studienzentrum Chemnitz GmbH Coordinator of this site? Confirm its status | Mittweida | Germany | Unknown status |
| Gemeinschaftspraxis Prof. Steinbach und Dr. Steib Coordinator of this site? Confirm its status | Nuremberg | Germany | Unknown status |
| Praxis Kuehn Coordinator of this site? Confirm its status | Oranienburg | Germany | Unknown status |
| Praxis Dipl.-med. Stefan Kusserow Coordinator of this site? Confirm its status | Stralsund | Germany | Unknown status |
| Hosp. de La Santa Creu I Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Gral. de Villalba Coordinator of this site? Confirm its status | Collado Villalba | Spain | Unknown status |
| Hosp. de Jerez de La Frontera Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Unknown status |
| Csm Fuencarral Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp. Univ. Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp Regional Univ de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Hosp. El Bierzo Coordinator of this site? Confirm its status | Ponferrada | Spain | Unknown status |
| Hosp. Univ. I Politecni La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Hosp. Prov. de Zamora Coordinator of this site? Confirm its status | Zamora | Spain | Unknown status |
| CHU Angers - Hôpital Hôtel Dieu# Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| CHU Clermont Ferrand - Hôpital Gabriel Montpied Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| Cabinet Medical des Drs Prizac-Desbonnet Scottez Coordinator of this site? Confirm its status | Douai | France | Unknown status |
| CHU de Grenoble - Hôpital Sud Coordinator of this site? Confirm its status | Isere | France | Unknown status |
| Hopital la Colombiere Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHU de Nantes - Hôtel Dieu Coordinator of this site? Confirm its status | Nantes | France | Unknown status |
| Cabinet De Psychiatrie Neurostim Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Groupe Hospitalier Pitie - Salpetriere Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Hopital Sainte Musse Coordinator of this site? Confirm its status | Toulon | France | Unknown status |
| Abraham Cowley Unit Coordinator of this site? Confirm its status | Chertsey | United Kingdom | Unknown status |
| Kingsway Hospital Coordinator of this site? Confirm its status | Derby | United Kingdom | Unknown status |
| Wonford House Hospital Coordinator of this site? Confirm its status | Exeter | United Kingdom | Unknown status |
| Kings College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Greater Manchester Mental Health NHSFT Coordinator of this site? Confirm its status | Manchester | United Kingdom | Unknown status |
| Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Unknown status |
| Lincolnshire Partnership NHS Foundation Trust (LPFT) Coordinator of this site? Confirm its status | Sleaford | United Kingdom | Unknown status |
| Moorgreen Hospital Coordinator of this site? Confirm its status | Southampton | United Kingdom | Unknown status |
| St Georges Hospital Coordinator of this site? Confirm its status | Stafford | United Kingdom | Unknown status |
| South West Yorkshire Trust Coordinator of this site? Confirm its status | Wakefield | United Kingdom | Unknown status |
| ASL ROMA Coordinator of this site? Confirm its status | Colleferro | Italy | Unknown status |
| Ospedale Policlinico San Martino IRCCS Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| AUSL LE di Lecce Coordinator of this site? Confirm its status | Lecce | Italy | Unknown status |
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliero Universitaria di Parma Coordinator of this site? Confirm its status | Parma | Italy | Unknown status |
| Università degli Studi di Perugia Coordinator of this site? Confirm its status | Perugia | Italy | Unknown status |
| Policlinico Tor Vergata Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| University of Siena Coordinator of this site? Confirm its status | Siena | Italy | Unknown status |
| Kyungpook National University Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| CHA University ilsan Medical Center Coordinator of this site? Confirm its status | Goyang | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| Jeju National University Hospital Coordinator of this site? Confirm its status | Jeju Special | South Korea | Unknown status |
| Gangnam Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Hallym University Kangdong Sacred Heart Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Gustavsbergs Vardcentral Coordinator of this site? Confirm its status | Gustavsberg | Sweden | Unknown status |
| Affecta Pskyiatrimottagning Coordinator of this site? Confirm its status | Halmstad | Sweden | Unknown status |
| ProbarE i Lund AB Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
| ONE LIFETIME Lakarmottagning Coordinator of this site? Confirm its status | Skövde | Sweden | Unknown status |
| Lehigh Center for Clinical Research Coordinator of this site? Confirm its status | Allentown | United States | Unknown status |
| Atlanta Behavioral Research, LLC Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| ATP Clinical Research Coordinator of this site? Confirm its status | California City | United States | Unknown status |
| University of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Missouri University Health Care South Providence Psychiatry Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Signature Research Associates, Inc. Coordinator of this site? Confirm its status | Fairlawn | United States | Unknown status |
| University of Connecticut Health Center Coordinator of this site? Confirm its status | Farmington | United States | Unknown status |
| University of Alabama at Birmingham 1 Coordinator of this site? Confirm its status | Homewood | United States | Unknown status |
| Psych Atlanta, P.C. Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Loyola University Medical Center Coordinator of this site? Confirm its status | Maywood | United States | Unknown status |
| Baber Research Group Coordinator of this site? Confirm its status | Naperville | United States | Unknown status |
| Lumin Health Coordinator of this site? Confirm its status | Newton | United States | Unknown status |
| Flagler Hospital and Florida Center for TMS Coordinator of this site? Confirm its status | Saint Augustine | United States | Unknown status |
| Center for Revitalizing Psychiatry Coordinator of this site? Confirm its status | Sarasota | United States | Unknown status |
| Seattle Neuropsychiatric Treatment Center Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| Interventional Psychiatry of Tampa Bay Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Univeristy of Massachusetts Coordinator of this site? Confirm its status | Worcester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.