A Standard of Care Study of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to a Selective Serotonin Reuptake/Serotonin-Norepinephrine Reuptake Inhibitor Antidepressant

NCT05109195 | Terminated FDA Drug

• 2 other identifiers: CR10906642847922MDD3009
• Study Type: observational
• Target: 7
• Locations: 2 countries
• Sites: 4

Brief Summary

The purpose of this study is to assess the safety (adverse events, serious adverse events, deaths, suicidality) of participants with major depressive disorder (MDD) treated according to the standard of care (SOC).

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (9)

• Number of Participants with Spontaneously Reported Adverse Events (AEs)

  Number of participants with spontaneously reported AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  Up to 1 year

• Number of Participants with AEs Collected through Generic Assessment of Side Effects (GASE)

  Number of participants with AEs collected through GASE will be reported. The GASE is an instrument to assess side effects in clinical studies that allows the detection of drug induced AEs.

  Up to 1 year

• Number of Participants with Hospitalization for Psychiatric Reasons

  Number of participants with hospitalizations for psychiatric reasons will be reported.

  Up to 1 year

• Number of Participants with Hospitalization for Medical Reasons

  Number of participants with hospitalizations for medical reasons will be reported.

  Up to 1 year

• Number of Participants with Other Serious Adverse Events (SAEs)

  SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

  Up to 1 year

• Number of Participants with Deaths

  Number of participants with deaths will be reported.

  Up to 1 year

• Number of Participants with Suicide Attempts and Completed Suicides

  Number of participants with suicide attempts and completed suicides will be reported.

  Up to 1 year

• Suicidality Assessment Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score

  Suicidality assessment using the C-SSRS will be reported. C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Worsening of suicidal ideation will be an increase in severity of suicidal ideation from baseline.

  Up to 1 year

• Number of Participants with Suicidal Ideation as Assessed by C-SSRS

  Number of participants with suicidal ideation as assessed by C-SSRS, particularly codes of 4 or 5 will be reported. C-SSRS is semi structured clinician-administered questionnaire designed to solicit the occurrence, severity, and frequency of suicide-related ideation and behaviors. Scale consists of 28 items in 4 sections: suicide behavior, actual attempts, suicidal ideation, and intensity of ideation. Suicidal ideation consists of 5 yes/no items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, active suicidal ideation with specific plan and intent. Worsening of suicidal ideation will be an increase in severity of suicidal ideation from baseline.

  Up to 1 year

Secondary Outcomes (12)

• Number of Participants with Adverse Events of Special Interest (AESI)

  Up to 1 year

• Change from Baseline in Weight Over Time

  Baseline (Week 1) up to 1 year

• Percentage of Participants with Clinically Meaningful Change in Weight

  Baseline (Week 1) to end of study (up to 1 Year)

• Change from Baseline in Hemoglobin Level Over Time

  Baseline (Week 1), Week 26 and Week 52

• Change from Baseline in Platelet and White Blood Cell (WBC) Count Over Time

  Baseline (Week 1), Week 26 and Week 52

Study Arms (1)

MDD Participants with Insufficient Response to SSRI/SNRI (antidepressant)

Major Depressive Disorder (MDD) participants with insufficient response to a selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) (antidepressant) and starting an adjunctive therapy will be observed to create an external control arm (ECA) based on real world data (RWD) from electronic health records (EHR) data during routine medical care (standard of care \[SOC\]) combined with scheduled research assessments.

Other: Standard of Care (SOC)

Interventions

Standard of Care (SOC) OTHER

Participants will not receive any intervention as a part of this study. Participants will receive SOC treatment.

MDD Participants with Insufficient Response to SSRI/SNRI (antidepressant)

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consists of participants who will have one of the augmenting agents started.

You may qualify if:

• Has a diagnosis of Major Depressive Disorder (MDD) without psychotic features as confirmed by the Mini International Neuropsychiatric Interview (MINI)
• Treatment with an selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor (SNRI) for at least 6 weeks at an adequate dose (per Massachusetts General Hospital-Antidepressant Treatment Response Questionnaire \[MGH-ATRQ\]). Specifically, one of the following in any formulation is allowed: SSRIs: citalopram, duloxetine, escitalopram, fluvoxamine, fluoxetine, milnacipran, levomilnacipran, paroxetine, sertraline; SNRIs: venlafaxine, desvenlafaxine, vilazodone, or vortioxetine
• In the opinion of the treating clinician, the participant requires augmentation of the current antidepressant treatment and plans to initiate augmentation treatment in the near future. The participant has agreed to receive augmentation treatment
• Is currently an outpatient receiving psychiatric care (not inpatient care settings)
• Has a body mass index (BMI) of 18-40 kilograms per meter square (Kg/m\^2), inclusive

You may not qualify if:

• Taking more than one antidepressant (regardless of class) at therapeutic doses (therapeutic doses per MGH-ATRQ). A second antidepressant is allowed to be taken at a lower dose if for sleep or pain management
• Is currently taking a benzodiazepine at higher doses than the equivalent of 3 milligrams (mg) of lorazepam
• Current diagnosis of a psychotic disorder including MDD with psychosis, bipolar disorder, intellectual disability, dementia, autism spectrum disorder, borderline personality disorder, or somatoform disorders
• Has treatment resistant depression (TRD) as defined by lack of response (less than \[\<\] 25 percent \[%\] improvement) of 2 or more antidepressants of adequate dose (per MGH-ATRQ) and duration (6 weeks) in this episode
• Current diagnosis of PTSD, obsessive compulsive disorder, fibromyalgia, anorexia nervosa, or bulimia nervosa. Participants may be enrolled if they have been in remission for the past year

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (4)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Brigham And Women's Hospital

Boston, Massachusetts, 02115, United States

Location

The University of Pittsburgh of the Commonwealth System of Higher Education

Pittsburgh, Pennsylvania, 15260, United States

Location

Warneford Hospital

Oxford, OX3 7JX, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 5, 2021
• Study Start: October 26, 2021
• Primary Completion: October 19, 2022
• Study Completion: October 19, 2022
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); GB (1)