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Observational study of patients with major depressive disorder and inadequate response to current antidepressants

A Study of Disease Characteristics and Real-life Standard of Care Effectiveness in Patients With Major Depressive Disorder (MDD) With Anhedonia and Inadequate Response to Current Antidepressant Therapy Including an SSRI or SNRI

Observational Janssen Research & Development, LLC · NCT05841030

This study looks at people with major depressive disorder who aren't getting better with their current antidepressants to see how their treatment and personal circumstances affect their condition.

Quick facts

Study typeObservational
Enrollment500 (estimated)
Ages18 Years to 74 Years
SexAll
SponsorJanssen Research & Development, LLC Industry-sponsored
Locations93 sites (Birmingham, Alabama and 92 other locations)
Trial IDNCT05841030 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the socio-demographic, disease-related, and treatment-related characteristics of participants suffering from major depressive disorder (MDD) with anhedonia who have not responded adequately to their current antidepressant therapy. Participants will be assessed based on their treatment patterns and the standard of care they receive. The study will involve individuals who are initiating or planning to initiate a new add-on antidepressant treatment to address their current depressive episode. No experimental interventions will be applied, as this is an observational study focused on real-world treatment scenarios.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with major depressive disorder who are experiencing anhedonia and have not adequately responded to current antidepressant treatments.

Not a fit: Patients with mild depressive symptoms or those not currently undergoing treatment for major depressive disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into effective treatment strategies for patients with MDD who do not respond to standard antidepressant therapies.

How similar studies have performed: Other observational studies have shown success in understanding treatment patterns in similar patient populations, suggesting that this approach could yield valuable data.

Eligibility criteria

Show full inclusion / exclusion criteria 
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)

Where this trial is running

Birmingham, Alabama and 92 other locations

+43 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Depressive Disorder, Major
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.