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)

Completed

Conditions studied: Depressive Disorder, Major

In brief

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.

Key facts

Study ID: NCT05841030
Run by: Janssen Research & Development, LLC
People needed: 545
Starts: 2023-04-28
Expected to finish: 2026-02-27
Last updated by the study team: 2026-04-23

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Hosp. El Bierzo — Ponferrada, Spain
Hosp. Univ. I Politecni La Fe — Valencia, Spain
Hosp. Prov. de Zamora — Zamora, Spain
Gustavsbergs Vardcentral — Gustavsberg, Sweden
University of Alabama at Birmingham — Birmingham, Alabama, United States
University of Alabama at Birmingham 1 — 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
Seattle Neuropsychiatric Treatment Center — Tacoma, Washington, United States
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales — Buenos Aires, Argentina
Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
Hosp Regional Univ de Malaga — Málaga, Spain

Full record on ClinicalTrials.gov

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