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 (82)
University of Alabama at Birmingham
๐บ๐ธHomewood, Alabama, United States
ATP Clinical Research
๐บ๐ธCalifornia City, California, United States
University of Connecticut Health Center
๐บ๐ธFarmington, Connecticut, United States
Flagler Hospital and Florida Center for TMS
๐บ๐ธSaint Augustine, Florida, United States
Center for Revitalizing Psychiatry
๐บ๐ธSarasota, Florida, United States
Interventional Psychiatry of Tampa Bay
๐บ๐ธTampa, Florida, United States
Atlanta Behavioral Research, LLC
๐บ๐ธAtlanta, Georgia, United States
Psych Atlanta, P.C.
๐บ๐ธMarietta, Georgia, United States
University of Chicago
๐บ๐ธChicago, Illinois, United States
Loyola University Medical Center
๐บ๐ธMaywood, Illinois, United States
Baber Research Group
๐บ๐ธNaperville, Illinois, United States
Univeristy of Massachusetts
๐บ๐ธWorcester, Massachusetts, United States
Missouri University Health Care South Providence Psychiatry
๐บ๐ธColumbia, Missouri, United States
Signature Research Associates Inc.
๐บ๐ธFairlawn, Ohio, United States
Lehigh Center for Clinical Research
๐บ๐ธAllentown, Pennsylvania, United States
Seattle Neuropsychiatric Treatment Center
๐บ๐ธTacoma, Washington, United States
Hospital Fleni
๐ฆ๐ทCiudad Autonoma Buenos Aires, Argentina
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
๐ฆ๐ทCiudad Autonoma de Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
๐ฆ๐ทCiudad Autonoma de Buenos Aires, Argentina
The Medical Arts Health Research Group
๐จ๐ฆWest Vancouver, British Columbia, Canada
Resolution
๐ฆ๐ทCiudad de Mendoza, Argentina
St. Michael's Hospital
๐จ๐ฆToronto, Ontario, Canada
CEN Consultorios Especializados en Neurociencias
๐ฆ๐ทCordoba, Argentina
Instituto Medico DAMIC
๐ฆ๐ทCordoba, Argentina
Centro Medico Luquez
๐ฆ๐ทCordoba, Argentina
Hospital Sao Vicente de Paulo
๐ง๐ทPasso Fundo, Brazil
Centro Integrado Facili
๐ง๐ทSao Bernardo do Campo, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
๐ง๐ทSao Jose Rio Preto, Brazil
Clinica Viver - Centro de Desospitalizacao Humana
๐ง๐ทSao Paulo, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
๐ง๐ทSao Paulo, Brazil
Jodha Tishon Inc.
๐จ๐ฆToronto, Ontario, Canada
Introspect Clinic
๐จ๐ฆOntario, Canada
CHU Angers - Hรดpital Hรดtel Dieu
๐ซ๐ทAngers, France
Groupe Hospitalier Pitie-Salpetriere
๐ซ๐ทParis, France
Praxis Dr. med. Kirsten Hahn
๐ฉ๐ชBerlin, Germany
Vivantes Klinikum Spandau
๐ฉ๐ชBerlin, Germany
Universitatsklinikum Jena
๐ฉ๐ชJena, Germany
Universitaetsklinikum Magdeburg A.oe.R
๐ฉ๐ชMagdeburg, Germany
Pharmakologisches Studienzentrum Chemnitz GmbH
๐ฉ๐ชMittweida, Germany
CHU Clermont-Ferrand - Hopital Gabriel Montpied
๐ซ๐ทClermont Ferrand, France
Hopital la Colombiere
๐ซ๐ทMontpellier Cedex 5, France
CHU de Nantes hotel Dieu
๐ซ๐ทNantes, France
Gemeinschaftspraxis Prof. Steinbach und Dr. Steib
๐ฉ๐ชNuernberg, Germany
Praxis Dipl.-med. Stefan Kusserow
๐ฉ๐ชStralsund, Germany
AUSL LE di Lecce
๐ฎ๐นLecce, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora
๐ฎ๐นMilano, Italy
Ospedale San Raffaele
๐ฎ๐นMilano, Italy
Policlinico Tor Vergata
๐ฎ๐นRoma, Italy
Kyungpook National University Hospital
๐ฐ๐ทDaegu, Korea, Republic of
CHA University ilsan Medical Center
๐ฐ๐ทGoyang, Korea, Republic of
Gachon University Gil Medical Center
๐ฐ๐ทIncheon, Korea, Republic of
Jeju National University Hospital
๐ฐ๐ทJeju Special, Korea, Republic of
Kangbuk Samsung Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Hallym University Kangdong Sacred Heart Hospital
๐ฐ๐ทSeoul, Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System
๐ฐ๐ทSeoul, Korea, Republic of
Samsung Medical Center
๐ฐ๐ทSeoul, Korea, Republic of
Hosp. de La Santa Creu I Sant Pau
๐ช๐ธBarcelona, Spain
Hosp Clinic de Barcelona
๐ช๐ธBarcelona, Spain
Hosp. Gral. de Villalba
๐ช๐ธCollado Villalba, Spain
Hosp. de Jerez de La Frontera
๐ช๐ธJerez de la Frontera, Spain
Hosp. Univ. Infanta Leonor
๐ช๐ธMadrid, Spain
Csm Fuencarral
๐ช๐ธMadrid, Spain
Hosp Regional Univ de Malaga
๐ช๐ธMรกlaga, Spain
Hosp. El Bierzo
๐ช๐ธPonferrada, Spain
Hosp. Univ. I Politecni La Fe
๐ช๐ธValencia, Spain
Hosp. Prov. de Zamora
๐ช๐ธZamora, Spain
Gustavsbergs Vardcentral
๐ธ๐ชGustavsberg, Sweden
Affecta Pskyiatrimottagning
๐ธ๐ชHalmstad, Sweden
ProbarE i Lund AB
๐ธ๐ชLund, Sweden
ONE LIFETIME Lakarmottagning
๐ธ๐ชSkovde, Sweden
Abraham Cowley Unit
๐ฌ๐งChertsey, United Kingdom
Kingsway Hospital
๐ฌ๐งDerby, United Kingdom
Wonford House Hospital
๐ฌ๐งExeter, United Kingdom
Greater Manchester Mental Health NHSFT
๐ฌ๐งManchester, United Kingdom
Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
๐ฌ๐งNewcastle upon Tyne, United Kingdom
Lincolnshire Partnership NHS Foundation Trust (LPFT)
๐ฌ๐งSleaford, United Kingdom
Moorgreen Hospital
๐ฌ๐งSouthampton, United Kingdom
St George's Hospital
๐ฌ๐งStafford, United Kingdom
South West Yorkshire Trust
๐ฌ๐งWakefield, United Kingdom
Lumin Health
๐บ๐ธNewton, Massachusetts, United States
Providence Care Hospital
๐จ๐ฆKingston, Ontario, Canada
Cabinet De Psychiatrie Neurostim
๐ซ๐ทParis, France