Clinical trial NCT05841030: 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)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Depressive Disorder, Major
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-05-03
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consists of participants with MDD with anhedonia who have had an inadequate response to an antidepressant.

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percentage of Participants With Different Socio-demographic Characteristics
timeFrame: Day 1
measure: Percentage of Participants with Disease-related Characteristics
timeFrame: Day 1
measure: Percentage of Participants With Type of Therapies and Treatment Strategies
timeFrame: Day 1
measure: Time to Next Antidepressant Treatment
timeFrame: Up to 12 months
measure: Percentage of Participants with Recurrence or Relapse
timeFrame: Up to 12 months
measure: Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score
timeFrame: Baseline, up to 12 months
measure: Percentage of Participants With Patient Global Impression of Severity (PGI-S) Scale Score for Sexual Functioning
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Homewood
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: California City
country: United States
facility: ATP Clinical Research
state: California
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Saint Augustine
country: United States
facility: Flagler Hospital and Florida Center for TMS
state: Florida
city: Sarasota
country: United States
facility: Center for Revitalizing Psychiatry
state: Florida
city: Tampa
country: United States
facility: Interventional Psychiatry of Tampa Bay
state: Florida
city: Atlanta
country: United States
facility: Atlanta Behavioral Research, LLC
state: Georgia
city: Marietta
country: United States
facility: Psych Atlanta, P.C.
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Naperville
country: United States
facility: Baber Research Group
state: Illinois
city: Newton
country: United States
facility: Lumin Health
state: Massachusetts
city: Worcester
country: United States
facility: Univeristy of Massachusetts
state: Massachusetts
city: Columbia
country: United States
facility: Missouri University Health Care South Providence Psychiatry
state: Missouri
city: Fairlawn
country: United States
facility: Signature Research Associates Inc.
state: Ohio
city: Allentown
country: United States
facility: Lehigh Center for Clinical Research
state: Pennsylvania
city: Tacoma
country: United States
facility: Seattle Neuropsychiatric Treatment Center
state: Washington
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Hospital Fleni
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Ciudad de Mendoza
country: Argentina
facility: Resolution
city: Cordoba
country: Argentina
facility: CEN Consultorios Especializados en Neurociencias
city: Cordoba
country: Argentina
facility: Instituto Medico DAMIC
city: Cordoba
country: Argentina
facility: Centro Medico Luquez
city: Passo Fundo
country: Brazil
facility: Hospital Sao Vicente de Paulo
city: Sao Bernardo do Campo
country: Brazil
facility: Centro Integrado Facili
city: Sao Jose Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
city: Sao Paulo
country: Brazil
facility: Clinica Viver - Centro de Desospitalizacao Humana
city: Sao Paulo
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP
city: West Vancouver
country: Canada
facility: The Medical Arts Health Research Group
state: British Columbia
city: Kingston
country: Canada
facility: Providence Care Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Jodha Tishon Inc.
state: Ontario
city: Ontario
country: Canada
facility: Introspect Clinic
city: Angers
country: France
facility: CHU Angers - Hopital Hotel Dieu
city: Clermont Ferrand
country: France
facility: CHU Clermont-Ferrand - Hopital Gabriel Montpied
city: Douai
country: France
facility: Cabinet Medical des Drs Prizac-Desbonnet Scottez
city: Montpellier Cedex 5
country: France
facility: Hopital la Colombiere
city: Nantes
country: France
facility: CHU de Nantes hotel Dieu
city: Paris
country: France
facility: Cabinet De Psychiatrie Neurostim
city: Paris
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
city: Aachen
country: Germany
facility: Universitaetsklinikum der RWTH Aachen
city: Berlin
country: Germany
facility: Praxis Dr. med. Kirsten Hahn
city: Berlin
country: Germany
facility: Vivantes Klinikum Spandau
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Mainz
country: Germany
facility: Universitatsmedizin der Johannes Gutenberg Universitat Mainz
city: Mittweida
country: Germany
facility: Pharmakologisches Studienzentrum Chemnitz GmbH
city: Nuernberg
country: Germany
facility: Gemeinschaftspraxis Prof. Steinbach und Dr. Steib
city: Oranienburg
country: Germany
facility: Praxis Kuehn
city: Stralsund
country: Germany
facility: Praxis Dipl.-med. Stefan Kusserow
city: Colleferro
country: Italy
facility: ASL ROMA
city: Genova
country: Italy
facility: Ospedale Policlinico San Martino IRCCS
city: Lecce
country: Italy
facility: AUSL LE di Lecce
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Perugia
country: Italy
facility: Universita degli Studi di Perugia
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Siena
country: Italy
facility: University of Siena
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Goyang
country: Korea, Republic of
facility: CHA University ilsan Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeju Special
country: Korea, Republic of
facility: Jeju National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Barcelona
country: Spain
facility: Hosp. de La Santa Creu I Sant Pau
city: Barcelona
country: Spain
facility: Hosp Clinic de Barcelona
city: Collado Villalba
country: Spain
facility: Hosp. Gral. de Villalba
city: Jerez de la Frontera
country: Spain
facility: Hosp. de Jerez de La Frontera
city: Madrid
country: Spain
facility: Hosp. Univ. Infanta Leonor
city: Madrid
country: Spain
facility: Csm Fuencarral
city: Málaga
country: Spain
facility: Hosp Regional Univ de Malaga
city: Ponferrada
country: Spain
facility: Hosp. El Bierzo
city: Valencia
country: Spain
facility: Hosp. Univ. I Politecni La Fe
city: Zamora
country: Spain
facility: Hosp. Prov. de Zamora
city: Gustavsberg
country: Sweden
facility: Gustavsbergs Vardcentral
city: Halmstad
country: Sweden
facility: Affecta Pskyiatrimottagning
city: Lund
country: Sweden
facility: ProbarE i Lund AB
city: Skovde
country: Sweden
facility: ONE LIFETIME Lakarmottagning
city: Chertsey
country: United Kingdom
facility: Abraham Cowley Unit
city: Derby
country: United Kingdom
facility: Kingsway Hospital
city: Exeter
country: United Kingdom
facility: Wonford House Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: Manchester
country: United Kingdom
facility: Greater Manchester Mental Health NHSFT
city: Newcastle upon Tyne
country: United Kingdom
facility: Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
city: Sleaford
country: United Kingdom
facility: Lincolnshire Partnership NHS Foundation Trust (LPFT)
city: Southampton
country: United Kingdom
facility: Moorgreen Hospital
city: Stafford
country: United Kingdom
facility: St George's Hospital
city: Wakefield
country: United Kingdom
facility: South West Yorkshire Trust
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: