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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)

Recruiting
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
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
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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)
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
MDD Participants With AnhedoniaNo InterventionData 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
NameTimeMethod
Percentage of Participants with Recurrence or RelapseUp to 12 months

Percentage of participants with recurrence or relapse will be reported.

Percentage of Participants With Different Socio-demographic CharacteristicsDay 1

Distribution of participants with different demographic characteristics will be assessed.

Percentage of Participants With Type of Therapies and Treatment StrategiesDay 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 ScoreBaseline, 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 FunctioningUp 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 CharacteristicsDay 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 TreatmentUp to 12 months

Time to next antidepressant treatment will be reported.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (82)

University of Alabama at Birmingham

๐Ÿ‡บ๐Ÿ‡ธ

Homewood, Alabama, United States

ATP Clinical Research

๐Ÿ‡บ๐Ÿ‡ธ

California City, California, United States

University of Connecticut Health Center

๐Ÿ‡บ๐Ÿ‡ธ

Farmington, Connecticut, United States

Flagler Hospital and Florida Center for TMS

๐Ÿ‡บ๐Ÿ‡ธ

Saint Augustine, Florida, United States

Center for Revitalizing Psychiatry

๐Ÿ‡บ๐Ÿ‡ธ

Sarasota, Florida, United States

Interventional Psychiatry of Tampa Bay

๐Ÿ‡บ๐Ÿ‡ธ

Tampa, Florida, United States

Atlanta Behavioral Research, LLC

๐Ÿ‡บ๐Ÿ‡ธ

Atlanta, Georgia, United States

Psych Atlanta, P.C.

๐Ÿ‡บ๐Ÿ‡ธ

Marietta, Georgia, United States

University of Chicago

๐Ÿ‡บ๐Ÿ‡ธ

Chicago, Illinois, United States

Loyola University Medical Center

๐Ÿ‡บ๐Ÿ‡ธ

Maywood, Illinois, United States

Baber Research Group

๐Ÿ‡บ๐Ÿ‡ธ

Naperville, Illinois, United States

Univeristy of Massachusetts

๐Ÿ‡บ๐Ÿ‡ธ

Worcester, Massachusetts, United States

Missouri University Health Care South Providence Psychiatry

๐Ÿ‡บ๐Ÿ‡ธ

Columbia, Missouri, United States

Signature Research Associates Inc.

๐Ÿ‡บ๐Ÿ‡ธ

Fairlawn, Ohio, United States

Lehigh Center for Clinical Research

๐Ÿ‡บ๐Ÿ‡ธ

Allentown, Pennsylvania, United States

Seattle Neuropsychiatric Treatment Center

๐Ÿ‡บ๐Ÿ‡ธ

Tacoma, Washington, United States

Hospital Fleni

๐Ÿ‡ฆ๐Ÿ‡ท

Ciudad Autonoma Buenos Aires, Argentina

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

๐Ÿ‡ฆ๐Ÿ‡ท

Ciudad Autonoma de Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

๐Ÿ‡ฆ๐Ÿ‡ท

Ciudad Autonoma de Buenos Aires, Argentina

The Medical Arts Health Research Group

๐Ÿ‡จ๐Ÿ‡ฆ

West Vancouver, British Columbia, Canada

Resolution

๐Ÿ‡ฆ๐Ÿ‡ท

Ciudad de Mendoza, Argentina

St. Michael's Hospital

๐Ÿ‡จ๐Ÿ‡ฆ

Toronto, Ontario, Canada

CEN Consultorios Especializados en Neurociencias

๐Ÿ‡ฆ๐Ÿ‡ท

Cordoba, Argentina

Instituto Medico DAMIC

๐Ÿ‡ฆ๐Ÿ‡ท

Cordoba, Argentina

Centro Medico Luquez

๐Ÿ‡ฆ๐Ÿ‡ท

Cordoba, Argentina

Hospital Sao Vicente de Paulo

๐Ÿ‡ง๐Ÿ‡ท

Passo Fundo, Brazil

Centro Integrado Facili

๐Ÿ‡ง๐Ÿ‡ท

Sao Bernardo do Campo, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

๐Ÿ‡ง๐Ÿ‡ท

Sao Jose Rio Preto, Brazil

Clinica Viver - Centro de Desospitalizacao Humana

๐Ÿ‡ง๐Ÿ‡ท

Sao Paulo, Brazil

Hospital Das Clinicas Da Faculdade De Medicina Da USP

๐Ÿ‡ง๐Ÿ‡ท

Sao Paulo, Brazil

Jodha Tishon Inc.

๐Ÿ‡จ๐Ÿ‡ฆ

Toronto, Ontario, Canada

Introspect Clinic

๐Ÿ‡จ๐Ÿ‡ฆ

Ontario, Canada

CHU Angers - Hรดpital Hรดtel Dieu

๐Ÿ‡ซ๐Ÿ‡ท

Angers, France

Groupe Hospitalier Pitie-Salpetriere

๐Ÿ‡ซ๐Ÿ‡ท

Paris, France

Praxis Dr. med. Kirsten Hahn

๐Ÿ‡ฉ๐Ÿ‡ช

Berlin, Germany

Vivantes Klinikum Spandau

๐Ÿ‡ฉ๐Ÿ‡ช

Berlin, Germany

Universitatsklinikum Jena

๐Ÿ‡ฉ๐Ÿ‡ช

Jena, Germany

Universitaetsklinikum Magdeburg A.oe.R

๐Ÿ‡ฉ๐Ÿ‡ช

Magdeburg, Germany

Pharmakologisches Studienzentrum Chemnitz GmbH

๐Ÿ‡ฉ๐Ÿ‡ช

Mittweida, Germany

CHU Clermont-Ferrand - Hopital Gabriel Montpied

๐Ÿ‡ซ๐Ÿ‡ท

Clermont Ferrand, France

Hopital la Colombiere

๐Ÿ‡ซ๐Ÿ‡ท

Montpellier Cedex 5, France

CHU de Nantes hotel Dieu

๐Ÿ‡ซ๐Ÿ‡ท

Nantes, France

Gemeinschaftspraxis Prof. Steinbach und Dr. Steib

๐Ÿ‡ฉ๐Ÿ‡ช

Nuernberg, Germany

Praxis Dipl.-med. Stefan Kusserow

๐Ÿ‡ฉ๐Ÿ‡ช

Stralsund, Germany

AUSL LE di Lecce

๐Ÿ‡ฎ๐Ÿ‡น

Lecce, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Pad. Marcora

๐Ÿ‡ฎ๐Ÿ‡น

Milano, Italy

Ospedale San Raffaele

๐Ÿ‡ฎ๐Ÿ‡น

Milano, Italy

Policlinico Tor Vergata

๐Ÿ‡ฎ๐Ÿ‡น

Roma, Italy

Kyungpook National University Hospital

๐Ÿ‡ฐ๐Ÿ‡ท

Daegu, Korea, Republic of

CHA University ilsan Medical Center

๐Ÿ‡ฐ๐Ÿ‡ท

Goyang, Korea, Republic of

Gachon University Gil Medical Center

๐Ÿ‡ฐ๐Ÿ‡ท

Incheon, Korea, Republic of

Jeju National University Hospital

๐Ÿ‡ฐ๐Ÿ‡ท

Jeju Special, Korea, Republic of

Kangbuk Samsung Hospital

๐Ÿ‡ฐ๐Ÿ‡ท

Seoul, Korea, Republic of

Hallym University Kangdong Sacred Heart Hospital

๐Ÿ‡ฐ๐Ÿ‡ท

Seoul, Korea, Republic of

Gangnam Severance Hospital, Yonsei University Health System

๐Ÿ‡ฐ๐Ÿ‡ท

Seoul, Korea, Republic of

Samsung Medical Center

๐Ÿ‡ฐ๐Ÿ‡ท

Seoul, Korea, Republic of

Hosp. de La Santa Creu I Sant Pau

๐Ÿ‡ช๐Ÿ‡ธ

Barcelona, Spain

Hosp Clinic de Barcelona

๐Ÿ‡ช๐Ÿ‡ธ

Barcelona, Spain

Hosp. Gral. de Villalba

๐Ÿ‡ช๐Ÿ‡ธ

Collado Villalba, Spain

Hosp. de Jerez de La Frontera

๐Ÿ‡ช๐Ÿ‡ธ

Jerez de la Frontera, Spain

Hosp. Univ. Infanta Leonor

๐Ÿ‡ช๐Ÿ‡ธ

Madrid, Spain

Csm Fuencarral

๐Ÿ‡ช๐Ÿ‡ธ

Madrid, Spain

Hosp Regional Univ de Malaga

๐Ÿ‡ช๐Ÿ‡ธ

Mรกlaga, Spain

Hosp. El Bierzo

๐Ÿ‡ช๐Ÿ‡ธ

Ponferrada, Spain

Hosp. Univ. I Politecni La Fe

๐Ÿ‡ช๐Ÿ‡ธ

Valencia, Spain

Hosp. Prov. de Zamora

๐Ÿ‡ช๐Ÿ‡ธ

Zamora, Spain

Gustavsbergs Vardcentral

๐Ÿ‡ธ๐Ÿ‡ช

Gustavsberg, Sweden

Affecta Pskyiatrimottagning

๐Ÿ‡ธ๐Ÿ‡ช

Halmstad, Sweden

ProbarE i Lund AB

๐Ÿ‡ธ๐Ÿ‡ช

Lund, Sweden

ONE LIFETIME Lakarmottagning

๐Ÿ‡ธ๐Ÿ‡ช

Skovde, Sweden

Abraham Cowley Unit

๐Ÿ‡ฌ๐Ÿ‡ง

Chertsey, United Kingdom

Kingsway Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Derby, United Kingdom

Wonford House Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Exeter, United Kingdom

Greater Manchester Mental Health NHSFT

๐Ÿ‡ฌ๐Ÿ‡ง

Manchester, United Kingdom

Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust

๐Ÿ‡ฌ๐Ÿ‡ง

Newcastle upon Tyne, United Kingdom

Lincolnshire Partnership NHS Foundation Trust (LPFT)

๐Ÿ‡ฌ๐Ÿ‡ง

Sleaford, United Kingdom

Moorgreen Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Southampton, United Kingdom

St George's Hospital

๐Ÿ‡ฌ๐Ÿ‡ง

Stafford, United Kingdom

South West Yorkshire Trust

๐Ÿ‡ฌ๐Ÿ‡ง

Wakefield, United Kingdom

Lumin Health

๐Ÿ‡บ๐Ÿ‡ธ

Newton, Massachusetts, United States

Providence Care Hospital

๐Ÿ‡จ๐Ÿ‡ฆ

Kingston, Ontario, Canada

Cabinet De Psychiatrie Neurostim

๐Ÿ‡ซ๐Ÿ‡ท

Paris, France

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