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Depressive Disorder, MajorVENTURA-RWENCT05841030

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)

An observational study of Depressive Disorder, Major, run by Janssen Research & Development, LLC at 95 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Depressive Disorder, Major
How many people
545 participants
Where
95 sitesin 11 countries
Study dates
28 Apr 2023to 27 Feb 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

95 sites in 11 countries.

95 sites in 11 countries

United States18 sites

  • Lehigh Center for Clinical Research

    Allentown, Pennsylvania, 18104

  • Atlanta Behavioral Research, LLC

    Atlanta, Georgia, 30338

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • ATP Clinical Research

    California City, California, 92626

  • University of Chicago

    Chicago, Illinois, 60637

  • Missouri University Health Care South Providence Psychiatry

    Columbia, Missouri, 65201

  • Signature Research Associates Inc.

    Fairlawn, Ohio, 44333

  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

  • University of Alabama at Birmingham 1

    Homewood, Alabama, 35209

  • Psych Atlanta, P.C.

    Marietta, Georgia, 30060

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Baber Research Group

    Naperville, Illinois, 60563

  • Lumin Health

    Newton, Massachusetts, 02459

  • Flagler Hospital and Florida Center for TMS

    Saint Augustine, Florida, 32086

  • Center for Revitalizing Psychiatry

    Sarasota, Florida, 34237

  • Seattle Neuropsychiatric Treatment Center

    Tacoma, Washington, 98405-1954

  • Interventional Psychiatry of Tampa Bay

    Tampa, Florida, 33629

  • Univeristy of Massachusetts

    Worcester, Massachusetts, 01605-2610

Other trials in United States

Germany10 sites

  • Universitaetsklinikum der RWTH Aachen

    Aachen, 52074

  • Praxis Dr. med. Kirsten Hahn

    Berlin, 13187

  • Vivantes Klinikum Spandau

    Berlin, 13585

  • Universitaetsklinikum Frankfurt

    Frankfurt, 60528

  • Universitatsklinikum Jena

    Jena, 07743

  • Universitatsmedizin der Johannes Gutenberg Universitat Mainz

    Mainz, 55131

  • Pharmakologisches Studienzentrum Chemnitz GmbH

    Mittweida, 09648

  • Gemeinschaftspraxis Prof. Steinbach und Dr. Steib

    Nuremberg, 90402

  • Praxis Kuehn

    Oranienburg, 16515

  • Praxis Dipl.-med. Stefan Kusserow

    Stralsund, 18439

Other trials in Germany

Spain10 sites

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08025

  • Hosp Clinic de Barcelona

    Barcelona, 08036

  • Hosp. Gral. de Villalba

    Collado Villalba, 28400

  • Hosp. de Jerez de La Frontera

    Jerez de la Frontera, 11407

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031

  • Csm Fuencarral

    Madrid, 28035

  • Hosp Regional Univ de Malaga

    Málaga, 29009

  • Hosp. El Bierzo

    Ponferrada, 24404

  • Hosp. Univ. I Politecni La Fe

    Valencia, 46126

  • Hosp. Prov. de Zamora

    Zamora, 49021

Other trials in Spain

United Kingdom10 sites

  • Abraham Cowley Unit

    Chertsey, KT16 9AU

  • Kingsway Hospital

    Derby, DE22 3LZ

  • Wonford House Hospital

    Exeter, EX2 5AF

  • Kings College Hospital

    London, SE5 8AF

  • Greater Manchester Mental Health NHSFT

    Manchester, M25 3BL

  • Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

    Newcastle upon Tyne, NE4 6BE

  • Lincolnshire Partnership NHS Foundation Trust (LPFT)

    Sleaford, NG34 8GG

  • Moorgreen Hospital

    Southampton, SO30 3JB

  • St Georges Hospital

    Stafford, ST16 3AG

  • South West Yorkshire Trust

    Wakefield, WF1 3SP

Other trials in United Kingdom

France9 sites

  • CHU Angers - Hopital Hotel Dieu

    Angers, 49100

  • CHU Clermont-Ferrand - Hopital Gabriel Montpied

    Clermont-Ferrand, 63000

  • Cabinet Medical des Drs Prizac-Desbonnet Scottez

    Douai, 59500

  • CHU de Grenoble - Hôpital Sud

    Isere, 38043

  • Hopital la Colombiere

    Montpellier, 34295

  • CHU de Nantes hotel Dieu

    Nantes, 44093

  • Cabinet De Psychiatrie Neurostim

    Paris, 75005

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, 75013

  • Hopital Sainte Musse

    Toulon, 83100

Other trials in France

Italy9 sites

  • ASL ROMA

    Colleferro, 00034

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132

  • AUSL LE di Lecce

    Lecce, 73100

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

    Milan, 20122

  • Ospedale San Raffaele

    Milan

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43125

  • Universita degli Studi di Perugia

    Perugia, 06123

  • Policlinico Tor Vergata

    Roma, 00133

  • University of Siena

    Siena, 53100

Other trials in Italy

South Korea8 sites

  • Kyungpook National University Hospital

    Daegu, 41944

  • CHA University ilsan Medical Center

    Goyang, 10414

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Jeju National University Hospital

    Jeju Special, 63241

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Hallym University Kangdong Sacred Heart Hospital

    Seoul, 05355

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Argentina7 sites

  • Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

    Buenos Aires, C1133AAH

  • Hospital Italiano de Buenos Aires

    Buenos Aires, C1181ACH

  • Hospital Fleni

    Ciudad Autonoma Buenos Aires, C1428AQK

  • CEN Consultorios Especializados en Neurociencias

    Córdoba, 5000FJF

  • Instituto Medico DAMIC

    Córdoba, X5003DCE

  • Centro Medico Luquez

    Córdoba, X5006IKK

  • Resolution

    Mendoza, M5502AHV

Other trials in Argentina

Brazil5 sites

  • Hospital Sao Vicente de Paulo

    Passo Fundo, 99010-080

  • Centro Integrado Facili

    São Bernardo do Campo, 09726 150

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

    Sao Jose Rio Preto, 15090 000

  • Clinica Viver - Centro de Desospitalizacao Humana

    São Paulo, 04020-060

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403-000

Other trials in Brazil

Canada5 sites

  • Providence Care Hospital

    Kingston, Ontario, K7L 4X3

  • Introspect Clinic

    Ontario, Ontario, K1C 1E9

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

  • Jodha Tishon Inc.

    Toronto, Ontario, M5S 3A3

  • The Medical Arts Health Research Group

    West Vancouver, British Columbia, V7T 1C5

Other trials in Canada

Sweden4 sites

  • Gustavsbergs Vardcentral

    Gustavsberg, 13440

  • Affecta Pskyiatrimottagning

    Halmstad, SE-30248

  • ProbarE i Lund AB

    Lund, 22222

  • ONE LIFETIME Lakarmottagning

    Skövde, SE-54150

Other trials in Sweden

About this study

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

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.

Being tested
No Intervention
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No InterventionOther

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

Study groups in NCT05841030
Study groupRoleWhat they receive
MDD Participants With AnhedoniaData 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.
Receives: Other: No Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Different Socio-demographic Characteristics

    Distribution of participants with different demographic characteristics will be assessed.

    Measured: Day 1

  2. 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.

    Measured: Day 1

  3. 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.

    Measured: Day 1

  4. Time to Next Antidepressant Treatment

    Time to next antidepressant treatment will be reported.

    Measured: Up to 12 months

  5. Percentage of Participants with Recurrence or Relapse

    Percentage of participants with recurrence or relapse will be reported.

    Measured: Up to 12 months

  6. 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.

    Measured: Baseline, up to 12 months

  7. 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.

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2023
  2. Study start28 Apr 2023
  3. Primary completion27 Feb 2026
  4. Study completion27 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
545 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05841030
Sponsor's protocol ID
CR109332
Other IDs
67953964MDD3004
Acronym
VENTURA-RWE
Status last verified
Apr 2026
First submitted
24 Apr 2023
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Depressive Disorder, Major, run by Janssen Research & Development, LLC at 95 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Germany, Spain, United Kingdom, France and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Different Socio-demographic Characteristics (time frame: Day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05841030.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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