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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) (VENTURA-RWE)

Last Updated   May 24, 2025

Want to learn how to participate in this trial?

CR109332

OVERVIEW

  • Sexes Eligible for Study
    all
  • Age
    18+ years
  • Phase
  • Sites
    93 Sites
  • Status
    Recruiting

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

ELIGIBILITY


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)


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

More...

DETAILS

LOCATIONS

Locations in:
United States, Argentina, Brazil, Canada, France, Germany, Italy, South Korea, Spain, Sweden, United Kingdom
Country (11) City or Province (93) Status
United States Birmingham University of Alabama at Birmingham
RECRUITING
United States Homewood University of Alabama at Birmingham
RECRUITING
United States California City ATP Clinical Research
RECRUITING
United States Farmington University of Connecticut Health Center
RECRUITING
United States Saint Augustine Flagler Hospital and Florida Center for TMS
RECRUITING
United States Sarasota Center for Revitalizing Psychiatry
RECRUITING
United States Tampa Interventional Psychiatry of Tampa Bay
RECRUITING
United States Atlanta Atlanta Behavioral Research, LLC
RECRUITING
United States Marietta Psych Atlanta, P.C.
RECRUITING
United States Chicago University of Chicago
RECRUITING
United States Naperville Baber Research Group
RECRUITING
United States Columbia Missouri University Health Care South Providence Psychiatry
RECRUITING
United States Fairlawn Signature Research Associates Inc.
RECRUITING
United States Allentown Lehigh Center for Clinical Research
RECRUITING
United States Tacoma Seattle Neuropsychiatric Treatment Center
RECRUITING
Argentina Ciudad Autonoma de Buenos Aires Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
RECRUITING
Argentina Ciudad de Mendoza Resolution
RECRUITING
Argentina Cordoba CEN Consultorios Especializados en Neurociencias
RECRUITING
Argentina Cordoba Instituto Medico DAMIC
RECRUITING
Argentina Cordoba Centro Medico Luquez
RECRUITING
Brazil Passo Fundo Hospital Sao Vicente de Paulo
RECRUITING
Brazil Sao Bernardo do Campo Centro Integrado Facili
RECRUITING
Canada Toronto Jodha Tishon Inc.
TERMINATED
Canada Ontario Introspect Clinic
RECRUITING
France Clermont Ferrand CHU Clermont-Ferrand - Hopital Gabriel Montpied
RECRUITING
France Montpellier Cedex 5 Hopital la Colombiere
RECRUITING
France Nantes CHU de Nantes hotel Dieu
RECRUITING
Germany Berlin Praxis Dr. med. Kirsten Hahn
RECRUITING
Germany Berlin Vivantes Klinikum Spandau
RECRUITING
Germany Jena Universitatsklinikum Jena
RECRUITING
Germany Mittweida Pharmakologisches Studienzentrum Chemnitz GmbH
RECRUITING
Germany Nuernberg Gemeinschaftspraxis Prof. Steinbach und Dr. Steib
RECRUITING
Germany Stralsund Praxis Dipl.-med. Stefan Kusserow
RECRUITING
Italy Milano Ospedale San Raffaele
RECRUITING
South Korea Goyang CHA University ilsan Medical Center
RECRUITING
South Korea Incheon Gachon University Gil Medical Center
RECRUITING
South Korea Jeju Special Jeju National University Hospital
RECRUITING
South Korea Seoul Kangbuk Samsung Hospital
RECRUITING
South Korea Seoul Hallym University Kangdong Sacred Heart Hospital
RECRUITING
South Korea Seoul Gangnam Severance Hospital, Yonsei University Health System
RECRUITING
South Korea Seoul Samsung Medical Center
RECRUITING
Spain Barcelona Hosp. de La Santa Creu I Sant Pau
RECRUITING
Spain Jerez de la Frontera Hosp. de Jerez de La Frontera
RECRUITING
Spain Madrid Hosp. Univ. Infanta Leonor
RECRUITING
Spain Madrid Csm Fuencarral
RECRUITING
Spain Ponferrada Hosp. El Bierzo
RECRUITING
Spain Valencia Hosp. Univ. I Politecni La Fe
RECRUITING
Spain Zamora Hosp. Prov. de Zamora
RECRUITING
Sweden Gustavsberg Gustavsbergs Vardcentral
RECRUITING
Sweden Halmstad Affecta Pskyiatrimottagning
RECRUITING
Sweden Lund ProbarE i Lund AB
RECRUITING
Sweden Skovde ONE LIFETIME Lakarmottagning
RECRUITING
United Kingdom Chertsey Abraham Cowley Unit
RECRUITING
United Kingdom Derby Kingsway Hospital
RECRUITING
United Kingdom Exeter Wonford House Hospital
RECRUITING
United Kingdom Newcastle upon Tyne Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
RECRUITING
United Kingdom Sleaford Lincolnshire Partnership NHS Foundation Trust (LPFT)
RECRUITING
United Kingdom Wakefield South West Yorkshire Trust
RECRUITING
Canada Toronto St. Michael's Hospital
RECRUITING
Italy Roma Policlinico Tor Vergata
RECRUITING
United Kingdom Southampton Moorgreen Hospital
RECRUITING
United Kingdom Stafford St George's Hospital
RECRUITING
United States Maywood Loyola University Medical Center
RECRUITING
United States Newton Lumin Health
RECRUITING
United States Worcester Univeristy of Massachusetts
TERMINATED
Argentina Ciudad Autonoma Buenos Aires Hospital Fleni
RECRUITING
Argentina Ciudad Autonoma de Buenos Aires Hospital Italiano de Buenos Aires
RECRUITING
Brazil Sao Jose Rio Preto Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
RECRUITING
Brazil Sao Paulo Hospital Das Clinicas Da Faculdade De Medicina Da USP
RECRUITING
Canada West Vancouver The Medical Arts Health Research Group
TERMINATED
Canada Kingston Providence Care Hospital
RECRUITING
France Angers CHU Angers - Hopital Hotel Dieu
RECRUITING
France Douai Cabinet Medical des Drs Prizac-Desbonnet Scottez
RECRUITING
France Paris Cabinet De Psychiatrie Neurostim
RECRUITING
France Paris Groupe Hospitalier Pitie-Salpetriere
RECRUITING
Germany Aachen Universitaetsklinikum der RWTH Aachen
RECRUITING
Germany Frankfurt Universitaetsklinikum Frankfurt
RECRUITING
Germany Mainz Universitatsmedizin der Johannes Gutenberg Universitat Mainz
RECRUITING
Germany Oranienburg Praxis Kuehn
TERMINATED
Italy Colleferro ASL ROMA
RECRUITING
Italy Genova Ospedale Policlinico San Martino IRCCS
RECRUITING
Italy Lecce AUSL LE di Lecce
RECRUITING
Italy Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora
RECRUITING
Italy Parma Azienda Ospedaliero Universitaria di Parma
RECRUITING
Italy Perugia Universita degli Studi di Perugia
RECRUITING
Italy Siena University of Siena
RECRUITING
South Korea Daegu Kyungpook National University Hospital
COMPLETED
Spain Barcelona Hosp Clinic de Barcelona
RECRUITING
Spain Collado Villalba Hosp. Gral. de Villalba
RECRUITING
Spain Málaga Hosp Regional Univ de Malaga
RECRUITING
United Kingdom London Kings College Hospital
RECRUITING
United Kingdom Manchester Greater Manchester Mental Health NHSFT
RECRUITING
Brazil Sao Paulo Clinica Viver - Centro de Desospitalizacao Humana
COMPLETED
Show More
Geo Locations

33.52066, -86.80249

33.47177, -86.80082

35.1258, -117.9859

41.71982, -72.83204

29.89469, -81.31452

27.33643, -82.53065

27.94752, -82.45843

33.749, -84.38798

33.9526, -84.54993

41.85003, -87.65005

41.78586, -88.14729

38.95171, -92.33407

41.12783, -81.60984

40.60843, -75.49018

47.25288, -122.44429

-34.61315, -58.37723

-32.89084, -68.82717

-31.4135, -64.18105

-31.4135, -64.18105

-31.4135, -64.18105

-28.26278, -52.40667

-23.69389, -46.565

43.70011, -79.4163

45.4694441, -75.5288328

45.77966, 3.08628

43.61092, 3.87723

47.21725, -1.55336

52.52437, 13.41053

52.52437, 13.41053

50.92878, 11.5899

50.98622, 12.97537

49.45421, 11.07752

54.30911, 13.0818

45.46427, 9.18951

37.65639, 126.835

37.45646, 126.70515

33.4631731, 126.5464274

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

37.566, 126.9784

41.38879, 2.15899

36.68645, -6.13606

40.4165, -3.70256

40.4165, -3.70256

42.54664, -6.59619

39.46975, -0.37739

41.50633, -5.74456

59.32684, 18.38975

56.67446, 12.85676

55.70584, 13.19321

58.39118, 13.84506

51.38812, -0.50782

52.92277, -1.47663

50.7236, -3.52751

54.97328, -1.61396

52.99826, -0.40941

53.68331, -1.49768

43.70011, -79.4163

41.89193, 12.51133

50.90395, -1.40428

52.80521, -2.11636

41.8792, -87.84312

42.33704, -71.20922

42.26259, -71.80229

-34.61315, -58.37723

-34.61315, -58.37723

-20.8289995, -49.3965773

-23.5475, -46.63611

49.36672, -123.16652

44.22976, -76.48101

47.46667, -0.55

50.36667, 3.06667

48.85341, 2.3488

48.85341, 2.3488

50.77664, 6.08342

50.11552, 8.68417

49.98419, 8.2791

52.75577, 13.24197

41.72722, 13.00481

44.40478, 8.94438

40.35481, 18.17244

45.46427, 9.18951

44.79935, 10.32618

43.1122, 12.38878

43.31822, 11.33064

35.87028, 128.59111

41.38879, 2.15899

40.63506, -4.00486

36.72016, -4.42034

51.50853, -0.12574

53.48095, -2.23743

-23.5475, -46.63611

x
50

Indicates 50+ sites in this region: click to zoom in.

10

Indicates 10+ sites in this region: click to zoom in.

5

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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