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)
- Conditions
- Depressive Disorder, Major
- Interventions
- Other: No Intervention
- Registration Number
- NCT05841030
- Lead Sponsor
- Janssen Research & Development, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
- 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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MDD Participants With Anhedonia No Intervention Data 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants with Recurrence or Relapse Up to 12 months Percentage of participants with recurrence or relapse will be reported.
Percentage of Participants With Different Socio-demographic Characteristics Day 1 Distribution of participants with different demographic characteristics will be assessed.
Percentage of Participants With Type of Therapies and Treatment Strategies Day 1 Percentage of participants with type of therapies (such as augmentation, combination therapy, etc.) and treatment strategies will be reported.
Change From Baseline in Changes in Sexual Functioning Questionnaire (CSFQ-14) Total Score Baseline, up to 12 months 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.
Percentage of Participants With Patient Global Impression of Severity (PGI-S) Scale Score for Sexual Functioning Up to 12 months 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.
Percentage of Participants with Disease-related Characteristics Day 1 Percentage of participants with disease-related characteristics which includes diagnosis/ disease history and psychiatric/ general medical comorbidities, will be reported.
Time to Next Antidepressant Treatment Up to 12 months Time to next antidepressant treatment will be reported.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (92)
CEN Consultorios Especializados en Neurociencias
🇦🇷Cordoba, Argentina
Instituto Medico DAMIC
🇦🇷Cordoba, Argentina
Centro Medico Luquez
🇦🇷Cordoba, Argentina
Hospital Sao Vicente de Paulo
🇧🇷Passo Fundo, Brazil
Centro Integrado Facili
🇧🇷Sao Bernardo do Campo, Brazil
Cabinet Medical des Drs Prizac-Desbonnet Scottez
🇫🇷Douai, France
Hopital la Colombiere
🇫🇷Montpellier Cedex 5, France
CHU de Nantes hotel Dieu
🇫🇷Nantes, France
Cabinet De Psychiatrie Neurostim
🇫🇷Paris, France
Groupe Hospitalier Pitie-Salpetriere
🇫🇷Paris, France
Universitaetsklinikum der RWTH Aachen
🇩🇪Aachen, Germany
Praxis Dr. med. Kirsten Hahn
🇩🇪Berlin, Germany
Vivantes Klinikum Spandau
🇩🇪Berlin, Germany
Universitaetsklinikum Frankfurt
🇩🇪Frankfurt, Germany
Universitatsklinikum Jena
🇩🇪Jena, Germany
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
🇩🇪Mainz, Germany
Pharmakologisches Studienzentrum Chemnitz GmbH
🇩🇪Mittweida, Germany
Gemeinschaftspraxis Prof. Steinbach und Dr. Steib
🇩🇪Nuernberg, Germany
Praxis Kuehn
🇩🇪Oranienburg, Germany
Praxis Dipl.-med. Stefan Kusserow
🇩🇪Stralsund, Germany
ASL ROMA
🇮🇹Colleferro, Italy
Ospedale Policlinico San Martino IRCCS
🇮🇹Genova, Italy
AUSL LE di Lecce
🇮🇹Lecce, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora
🇮🇹Milano, Italy
Ospedale San Raffaele
🇮🇹Milano, Italy
Azienda Ospedaliero Universitaria di Parma
🇮🇹Parma, Italy
Universita degli Studi di Perugia
🇮🇹Perugia, Italy
Hosp. Gral. de Villalba
🇪🇸Collado Villalba, Spain
Hosp. de Jerez de La Frontera
🇪🇸Jerez de la Frontera, Spain
Hosp. Univ. Infanta Leonor
🇪🇸Madrid, Spain
Csm Fuencarral
🇪🇸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, Spain
Gustavsbergs Vardcentral
🇸🇪Gustavsberg, Sweden
Affecta Pskyiatrimottagning
🇸🇪Halmstad, Sweden
ProbarE i Lund AB
🇸🇪Lund, Sweden
ONE LIFETIME Lakarmottagning
🇸🇪Skovde, Sweden
Abraham Cowley Unit
🇬🇧Chertsey, United Kingdom
Kingsway Hospital
🇬🇧Derby, United Kingdom
Wonford House Hospital
🇬🇧Exeter, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
Greater Manchester Mental Health NHSFT
🇬🇧Manchester, United Kingdom
University of Alabama at Birmingham
🇺🇸Homewood, Alabama, United States
ATP Clinical Research
🇺🇸California City, California, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Flagler Hospital and Florida Center for TMS
🇺🇸Saint Augustine, Florida, United States
Center for Revitalizing Psychiatry
🇺🇸Sarasota, Florida, United States
Interventional Psychiatry of Tampa Bay
🇺🇸Tampa, Florida, United States
Atlanta Behavioral Research, LLC
🇺🇸Atlanta, Georgia, United States
Psych Atlanta, P.C.
🇺🇸Marietta, Georgia, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Baber Research Group
🇺🇸Naperville, Illinois, United States
Lumin Health
🇺🇸Newton, Massachusetts, United States
Univeristy of Massachusetts
🇺🇸Worcester, Massachusetts, United States
Missouri University Health Care South Providence Psychiatry
🇺🇸Columbia, Missouri, United States
Signature Research Associates Inc.
🇺🇸Fairlawn, Ohio, United States
Lehigh Center for Clinical Research
🇺🇸Allentown, Pennsylvania, United States
Hospital Fleni
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Seattle Neuropsychiatric Treatment Center
🇺🇸Tacoma, Washington, United States
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Ciudad Autonoma de Buenos Aires, Argentina
Resolution
🇦🇷Ciudad de Mendoza, Argentina
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
🇧🇷Sao Jose Rio Preto, Brazil
Clinica Viver - Centro de Desospitalizacao Humana
🇧🇷Sao Paulo, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
🇧🇷Sao Paulo, Brazil
The Medical Arts Health Research Group
🇨🇦West Vancouver, British Columbia, Canada
Providence Care Hospital
🇨🇦Kingston, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Jodha Tishon Inc.
🇨🇦Toronto, Ontario, Canada
Introspect Clinic
🇨🇦Ontario, Canada
CHU Angers - Hopital Hotel Dieu
🇫🇷Angers, France
CHU Clermont-Ferrand - Hopital Gabriel Montpied
🇫🇷Clermont Ferrand, France
Policlinico Tor Vergata
🇮🇹Roma, Italy
University of Siena
🇮🇹Siena, Italy
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
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Hosp. de La Santa Creu I Sant Pau
🇪🇸Barcelona, Spain
Hosp Clinic de Barcelona
🇪🇸Barcelona, Spain
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
🇬🇧Newcastle upon Tyne, United Kingdom
Lincolnshire Partnership NHS Foundation Trust (LPFT)
🇬🇧Sleaford, United Kingdom
Moorgreen Hospital
🇬🇧Southampton, United Kingdom
St George's Hospital
🇬🇧Stafford, United Kingdom
South West Yorkshire Trust
🇬🇧Wakefield, United Kingdom