Fact CheckerSign in

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

Full criteria on ClinicalTrials.gov

Sites (95)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Italiano de Buenos Aires
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
Coordinator of this site? Confirm its status
Buenos AiresArgentinaUnknown status
Hospital Fleni
Coordinator of this site? Confirm its status
Ciudad Autonoma Buenos AiresArgentinaUnknown status
Centro Médico Luquez
Coordinator of this site? Confirm its status
CórdobaArgentinaUnknown status
Instituto Médico DAMIC
Coordinator of this site? Confirm its status
CórdobaArgentinaUnknown status
CEN Consultorios Especializados en Neurociencias
Coordinator of this site? Confirm its status
CórdobaArgentinaUnknown status
Resolution
Coordinator of this site? Confirm its status
MendozaArgentinaUnknown status
Hospital São Vicente de Paulo
Coordinator of this site? Confirm its status
Passo FundoBrazilUnknown status
Centro Integrado Facili
Coordinator of this site? Confirm its status
São Bernardo do CampoBrazilUnknown 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 PretoBrazilUnknown status
Hospital das Clinicas da Faculdade de Medicina da USP
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Clinica Viver - Centro de Desospitalizacao Humana
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Providence care Hospital
Coordinator of this site? Confirm its status
KingstonCanadaUnknown status
Introspect Clinic
Coordinator of this site? Confirm its status
OntarioCanadaUnknown status
Jodha Tishon Inc.
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
St. Michael's Hospital
Coordinator of this site? Confirm its status
TorontoCanadaUnknown status
The Medical Arts Health Research Group
Coordinator of this site? Confirm its status
West VancouverCanadaUnknown status
Universitaetsklinikum der RWTH Aachen
Coordinator of this site? Confirm its status
AachenGermanyUnknown status
Praxis Dr. med. Kirsten Hahn
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Vivantes Klinikum Spandau
Coordinator of this site? Confirm its status
BerlinGermanyUnknown status
Universitaetsklinikum Frankfurt
Coordinator of this site? Confirm its status
FrankfurtGermanyUnknown status
Universitätsklinikum Jena
Coordinator of this site? Confirm its status
JenaGermanyUnknown status
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Coordinator of this site? Confirm its status
MainzGermanyUnknown status
Pharmakologisches Studienzentrum Chemnitz GmbH
Coordinator of this site? Confirm its status
MittweidaGermanyUnknown status
Gemeinschaftspraxis Prof. Steinbach und Dr. Steib
Coordinator of this site? Confirm its status
NurembergGermanyUnknown status
Praxis Kuehn
Coordinator of this site? Confirm its status
OranienburgGermanyUnknown status
Praxis Dipl.-med. Stefan Kusserow
Coordinator of this site? Confirm its status
StralsundGermanyUnknown status
Hosp. de La Santa Creu I Sant Pau
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Hosp Clinic de Barcelona
Coordinator of this site? Confirm its status
BarcelonaSpainUnknown status
Hosp. Gral. de Villalba
Coordinator of this site? Confirm its status
Collado VillalbaSpainUnknown status
Hosp. de Jerez de La Frontera
Coordinator of this site? Confirm its status
Jerez de la FronteraSpainUnknown status
Csm Fuencarral
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Hosp. Univ. Infanta Leonor
Coordinator of this site? Confirm its status
MadridSpainUnknown status
Hosp Regional Univ de Malaga
Coordinator of this site? Confirm its status
MálagaSpainUnknown status
Hosp. El Bierzo
Coordinator of this site? Confirm its status
PonferradaSpainUnknown status
Hosp. Univ. I Politecni La Fe
Coordinator of this site? Confirm its status
ValenciaSpainUnknown status
Hosp. Prov. de Zamora
Coordinator of this site? Confirm its status
ZamoraSpainUnknown status
CHU Angers - Hôpital Hôtel Dieu#
Coordinator of this site? Confirm its status
AngersFranceUnknown status
CHU Clermont Ferrand - Hôpital Gabriel Montpied
Coordinator of this site? Confirm its status
Clermont-FerrandFranceUnknown status
Cabinet Medical des Drs Prizac-Desbonnet Scottez
Coordinator of this site? Confirm its status
DouaiFranceUnknown status
CHU de Grenoble - Hôpital Sud
Coordinator of this site? Confirm its status
IsereFranceUnknown status
Hopital la Colombiere
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
CHU de Nantes - Hôtel Dieu
Coordinator of this site? Confirm its status
NantesFranceUnknown status
Cabinet De Psychiatrie Neurostim
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Groupe Hospitalier Pitie - Salpetriere
Coordinator of this site? Confirm its status
ParisFranceUnknown status
Hopital Sainte Musse
Coordinator of this site? Confirm its status
ToulonFranceUnknown status
Abraham Cowley Unit
Coordinator of this site? Confirm its status
ChertseyUnited KingdomUnknown status
Kingsway Hospital
Coordinator of this site? Confirm its status
DerbyUnited KingdomUnknown status
Wonford House Hospital
Coordinator of this site? Confirm its status
ExeterUnited KingdomUnknown status
Kings College Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Greater Manchester Mental Health NHSFT
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
Coordinator of this site? Confirm its status
Newcastle upon TyneUnited KingdomUnknown status
Lincolnshire Partnership NHS Foundation Trust (LPFT)
Coordinator of this site? Confirm its status
SleafordUnited KingdomUnknown status
Moorgreen Hospital
Coordinator of this site? Confirm its status
SouthamptonUnited KingdomUnknown status
St Georges Hospital
Coordinator of this site? Confirm its status
StaffordUnited KingdomUnknown status
South West Yorkshire Trust
Coordinator of this site? Confirm its status
WakefieldUnited KingdomUnknown status
ASL ROMA
Coordinator of this site? Confirm its status
ColleferroItalyUnknown status
Ospedale Policlinico San Martino IRCCS
Coordinator of this site? Confirm its status
GenovaItalyUnknown status
AUSL LE di Lecce
Coordinator of this site? Confirm its status
LecceItalyUnknown status
Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora
Coordinator of this site? Confirm its status
MilanItalyUnknown status
Azienda Ospedaliero Universitaria di Parma
Coordinator of this site? Confirm its status
ParmaItalyUnknown status
Università degli Studi di Perugia
Coordinator of this site? Confirm its status
PerugiaItalyUnknown status
Policlinico Tor Vergata
Coordinator of this site? Confirm its status
RomaItalyUnknown status
University of Siena
Coordinator of this site? Confirm its status
SienaItalyUnknown status
Kyungpook National University Hospital
Coordinator of this site? Confirm its status
DaeguSouth KoreaUnknown status
CHA University ilsan Medical Center
Coordinator of this site? Confirm its status
GoyangSouth KoreaUnknown status
Gachon University Gil Medical Center
Coordinator of this site? Confirm its status
IncheonSouth KoreaUnknown status
Jeju National University Hospital
Coordinator of this site? Confirm its status
Jeju SpecialSouth KoreaUnknown status
Gangnam Severance Hospital, Yonsei University Health System
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Hallym University Kangdong Sacred Heart Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Gustavsbergs Vardcentral
Coordinator of this site? Confirm its status
GustavsbergSwedenUnknown status
Affecta Pskyiatrimottagning
Coordinator of this site? Confirm its status
HalmstadSwedenUnknown status
ProbarE i Lund AB
Coordinator of this site? Confirm its status
LundSwedenUnknown status
ONE LIFETIME Lakarmottagning
Coordinator of this site? Confirm its status
SkövdeSwedenUnknown status
Lehigh Center for Clinical Research
Coordinator of this site? Confirm its status
AllentownUnited StatesUnknown status
Atlanta Behavioral Research, LLC
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
ATP Clinical Research
Coordinator of this site? Confirm its status
California CityUnited StatesUnknown status
University of Chicago
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Missouri University Health Care South Providence Psychiatry
Coordinator of this site? Confirm its status
ColumbiaUnited StatesUnknown status
Signature Research Associates, Inc.
Coordinator of this site? Confirm its status
FairlawnUnited StatesUnknown status
University of Connecticut Health Center
Coordinator of this site? Confirm its status
FarmingtonUnited StatesUnknown status
University of Alabama at Birmingham 1
Coordinator of this site? Confirm its status
HomewoodUnited StatesUnknown status
Psych Atlanta, P.C.
Coordinator of this site? Confirm its status
MariettaUnited StatesUnknown status
Loyola University Medical Center
Coordinator of this site? Confirm its status
MaywoodUnited StatesUnknown status
Baber Research Group
Coordinator of this site? Confirm its status
NapervilleUnited StatesUnknown status
Lumin Health
Coordinator of this site? Confirm its status
NewtonUnited StatesUnknown status
Flagler Hospital and Florida Center for TMS
Coordinator of this site? Confirm its status
Saint AugustineUnited StatesUnknown status
Center for Revitalizing Psychiatry
Coordinator of this site? Confirm its status
SarasotaUnited StatesUnknown status
Seattle Neuropsychiatric Treatment Center
Coordinator of this site? Confirm its status
TacomaUnited StatesUnknown status
Interventional Psychiatry of Tampa Bay
Coordinator of this site? Confirm its status
TampaUnited StatesUnknown status
Univeristy of Massachusetts
Coordinator of this site? Confirm its status
WorcesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.