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)

Active, not recruiting

• Conditions: Depressive Disorder, Major

• 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

Study Timeline

• Study First Submitted: 2023-04-24
• Study First Submitted QC: 2023-04-24
• Study Start: 2023-04-28
• Study First Posted: 2023-05-03
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-11
• Last Update Posted: 2025-09-12
• Primary Completion: 2025-11-21
• Study Completion: 2025-11-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 545

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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.

Trial Locations

Locations (93)

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

Scroll for more (83 remaining)