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)

Depressive Disorder, Major Clinical Trial

— VENTURA-RWE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05841030
• Other study ID #: CR109332
• Secondary ID: 67953964MDD3004
• Status: Recruiting
• Start date: April 28, 2023
• Est. completion date: November 25, 2025

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 according to the standard of care treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 25, 2025
• Est. primary completion date: November 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 74 Years

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)

Related Conditions & MeSH terms

• Anhedonia
• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

Other:
• No Intervention
There is no interventional treatment administered to the participants as a part of this study.

Locations

Country	Name	City	State
Argentina	Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales	Ciudad Autonoma de Buenos Aires
Argentina	Resolution	Ciudad de Mendoza
Argentina	CEN Consultorios Especializados en Neurociencias	Cordoba
Argentina	Centro Medico Luquez	Cordoba
Argentina	Instituto Medico DAMIC	Cordoba
Brazil	Centro Integrado Facili	Sao Bernardo do Campo
Brazil	Fundacao Faculdade Regional De Medicina De Sao Jose Do Rio Preto	Sao Jose Rio Preto
Brazil	Clinica Viver - Centro de Desospitalizacao Humana	Sao Paulo
Canada	Introspect Clinic	Ontario
Canada	Jodha Tishon Inc.	Toronto	Ontario
Canada	The Medical Arts Health Research Group	West Vancouver	British Columbia
France	CHU Angers - Hôpital Hôtel Dieu	Angers
France	CHU Clermont-Ferrand - Hopital Gabriel Montpied	Clermont Ferrand
France	CHU de Nantes hotel Dieu	Nantes
Germany	Praxis Dr. med. Kirsten Hahn	Berlin
Germany	Vivantes Klinikum Spandau	Berlin
Germany	Universitatsklinikum Jena	Jena
Germany	Pharmakologisches Studienzentrum Chemnitz GmbH	Mittweida
Germany	Gemeinschaftspraxis Prof. Steinbach und Dr. Steib	Nuernberg
Germany	Praxis Dipl.-med. Stefan Kusserow	Stralsund
Italy	Ospedale San Raffaele	Milano
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	CHA University ilsan Medical Center	Goyang
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Jeju National University Hospital	Jeju Special
Korea, Republic of	Gangnam Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Hallym University Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Spain	Hosp. de La Santa Creu I Sant Pau	Barcelona
Spain	Hosp. de Jerez de La Frontera	Jerez de la Frontera
Spain	Csm Fuencarral	Madrid
Spain	Hosp. Univ. Infanta Leonor	Madrid
Spain	Hosp. Regional Univ. de Malaga	Málaga
Spain	Hosp. El Bierzo	Ponferrada
Spain	Hosp. Univ. I Politecni La Fe	Valencia
Spain	Hosp. Prov. de Zamora	Zamora
Sweden	Gustavsbergs Vardcentral	Gustavsberg
Sweden	Affecta Pskyiatrimottagning	Halmstad
Sweden	ProbarE i Lund AB	Lund
Sweden	ONE LIFETIME Lakarmottagning	Skovde
United Kingdom	Kingsway Hospital	Derby
United Kingdom	Wonford House Hospital	Exeter
United Kingdom	Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust	Newcastle upon Tyne
United Kingdom	Lincolnshire Partnership NHS Foundation Trust (LPFT)	Sleaford
United States	Lehigh Center for Clinical Research	Allentown	Pennsylvania
United States	Atlanta Behavioral Research, LLC	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	ATP Clinical Research	California City	California
United States	University of Chicago	Chicago	Illinois
United States	Missouri University Health Care South Providence Psychiatry	Columbia	Missouri
United States	Signature Research Associates Inc.	Fairlawn	Ohio
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	University of Alabama at Birmingham	Homewood	Alabama
United States	Psych Atlanta, P.C.	Marietta	Georgia
United States	Baber Research Group	Naperville	Illinois
United States	Flagler Hospital and Florida Center for TMS	Saint Augustine	Florida
United States	Center for Revitalizing Psychiatry	Sarasota	Florida
United States	Seattle Neuropsychiatric Treatment Center	Tacoma	Washington
United States	Interventional Psychiatry of Tampa Bay	Tampa	Florida
United States	Univeristy of Massachusetts	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Different Socio-demographic Characteristics	Distribution of participants with different demographic characteristics will be assessed.	Day 1
Primary	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.	Day 1
Primary	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.	Day 1
Primary	Time to Next Antidepressant Treatment	Time to next antidepressant treatment will be reported.	Up to 12 months
Primary	Percentage of Participants with Recurrence or Relapse	Percentage of participants with recurrence or relapse will be reported.	Up to 12 months
Primary	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.	Baseline, up to 12 months
Primary	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.	Up to 12 months