A Study in Participants With Major Depressive Disorder (MDD) With Anhedonia and Inadequate Response

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 February 22, 2025

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CR109332

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
Sites
70 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:

More...

DETAILS

LOCATIONS

Locations in:

United States, Argentina, Brazil, Canada, France, Germany, Italy, South Korea, Spain, Sweden, United Kingdom

Country (11)	City or Province (70)	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	Worcester Univeristy of Massachusetts	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
Brazil	Sao Jose Rio Preto Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto	RECRUITING
Brazil	Sao Paulo Clinica Viver - Centro de Desospitalizacao Humana	RECRUITING
Canada	West Vancouver The Medical Arts Health Research Group	RECRUITING
Canada	Toronto Jodha Tishon Inc.	TERMINATED
Canada	Ontario Introspect Clinic	RECRUITING
France	Angers CHU Angers - Hôpital Hôtel Dieu	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	Magdeburg Universitaetsklinikum Magdeburg A.oe.R	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	Daegu Kyungpook National University Hospital	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	Málaga Hosp. Regional Univ. de Malaga	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

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

42.26259, -71.80229

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

-28.26278, -52.40667

-23.69389, -46.565

-20.8289995, -49.3965773

-23.5475, -46.63611

49.36672, -123.16652

43.70011, -79.4163

45.4694441, -75.5288328

47.46667, -0.55

45.77966, 3.08628

43.61092, 3.87723

47.21725, -1.55336

52.52437, 13.41053

50.92878, 11.5899

52.12773, 11.62916

50.98622, 12.97537

49.45421, 11.07752

54.30911, 13.0818

45.46427, 9.18951

35.87028, 128.59111

37.65639, 126.835

37.45646, 126.70515

33.4631731, 126.5464274

37.566, 126.9784

41.38879, 2.15899

36.68645, -6.13606

40.4165, -3.70256

36.72016, -4.42034

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

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

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

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

Corresponds to individual site.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

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

42.26259, -71.80229

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

-20.8289995, -49.3965773

-23.5475, -46.63611

49.36672, -123.16652

43.70011, -79.4163

45.4694441, -75.5288328

47.46667, -0.55

45.77966, 3.08628

43.61092, 3.87723

47.21725, -1.55336

52.52437, 13.41053

52.52437, 13.41053

50.92878, 11.5899

52.12773, 11.62916

50.98622, 12.97537

49.45421, 11.07752

54.30911, 13.0818

45.46427, 9.18951

35.87028, 128.59111

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

36.72016, -4.42034

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