Depressive Disorder, MajorNCT05109195
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
An observational study of Depressive Disorder, Major, run by Janssen Research & Development, LLC at 4 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Depressive Disorder, Major
- How many people
- 7 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 26 Oct 2021to 19 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consists of participants who will have one of the augmenting agents started.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Brigham And Women's Hospital
Boston, Massachusetts, 02115
The University of Pittsburgh of the Commonwealth System of Higher Education
Pittsburgh, Pennsylvania, 15260
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: A Prospective, Observational 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 as a Control Arm for the Safety Assessments in the Seltorexant Phase 3 Program
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
- Being tested
- Standard of Care (SOC)
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SOC)Other
Participants will not receive any intervention as a part of this study. Participants will receive SOC treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 1 year
Number of Participants with Hospitalization for Psychiatric Reasons
Number of participants with hospitalizations for psychiatric reasons will be reported.
Measured: Up to 1 year
Number of Participants with Hospitalization for Medical Reasons
Number of participants with hospitalizations for medical reasons will be reported.
Measured: 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.
Measured: Up to 1 year
Number of Participants with Deaths
Number of participants with deaths will be reported.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 1 year
Secondary outcomes (12)
Number of Participants with Adverse Events of Special Interest (AESI)
Number of participants with AESI: Cataplexy, Sleep paralysis, Complex sleep-related behaviors, Falls, Motor vehicle accidents will be reported.
Measured: Up to 1 year
Change from Baseline in Weight Over Time
Change from baseline in weight over time will be reported.
Measured: Baseline (Week 1) up to 1 year
Percentage of Participants with Clinically Meaningful Change in Weight
Percentage of participants with clinically meaningful change in weight (greater than or equal to [>=] 7 percent [%]) from baseline to end of study will be reported.
Measured: Baseline (Week 1) to end of study (up to 1 Year)
Change from Baseline in Hemoglobin Level Over Time
Change from baseline in hemoglobin level over time will be reported.
Measured: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Platelet and White Blood Cell (WBC) Count Over Time
Change from baseline in platelet and WBC count with differential over time will be reported.
Measured: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Hematocrit Level Over Time
Change from baseline in hematocrit level over time will be reported.
Measured: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Red Blood Cell (RBC) Count Over Time
Change from baseline in RBC count over time will be reported.
Measured: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Sodium, Potassium, Chloride and Bicarbonate Level Over Time
Change from baseline in sodium, potassium, chloride and bicarbonate level over time will be reported.
Measured: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Blood Urea Nitrogen (BUN), Creatinine, Glucose, Total and Direct Bilirubin, Calcium and Phosphate Level Over Time
Change from baseline in BUN, creatinine, glucose, total and direct bilirubin, calcium and phosphate level over time will be reported.
Measured: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase Level Over Time
Change from baseline in AST, ALT, alkaline phosphatase level over time will be reported.
Measured: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Albumin and Total Protein Level Over Time
Change from baseline in albumin and total protein level over time will be reported.
Measured: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Total Cholesterol, Low-density Lipoprotein Cholesterol, Triglycerides, High-density Lipoprotein Cholesterol Level Over Time
Change from baseline in total cholesterol, low-density lipoprotein cholesterol (calculated), triglycerides, high-density lipoprotein cholesterol level over time will be reported.
Measured: Baseline (Week 1), Week 26 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start26 Oct 2021
- Primary completion19 Oct 2022
- Study completion19 Oct 2022
Why it stopped: due to business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109195
- Sponsor's protocol ID
- CR109066
- Other IDs
- 42847922MDD3009
- Status last verified
- Apr 2025
- First submitted
- 26 Oct 2021
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational 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 as a Control Arm for the Safety Assessments in the Seltorexant Phase 3 Program
- ClinicalTrials.gov ID
- NCT05109195
- Acronym / sponsor ID
- CR109066
- Conditions
- Depressive Disorder, Major
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to business reasons.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2021 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 19 Oct 2022 (actual)
- First posted
- 5 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDD Participants with Insufficient Response to SSRI/SNRI (antidepressant) | – | Other: Standard of Care (SOC)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. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consists of participants who will have one of the augmenting agents started.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care (SOC)Participants will not receive any intervention as a part of this study. Participants will receive SOC treatment. | Other | MDD Participants with Insufficient Response to SSRI/SNRI (antidepressant) |
Primary outcome
Number of Participants with Spontaneously Reported Adverse Events (AEs)
Time frame: Up to 1 year
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.
Number of Participants with AEs Collected through Generic Assessment of Side Effects (GASE)
Time frame: Up to 1 year
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.
Number of Participants with Hospitalization for Psychiatric Reasons
Time frame: Up to 1 year
Number of participants with hospitalizations for psychiatric reasons will be reported.
Number of Participants with Hospitalization for Medical Reasons
Time frame: Up to 1 year
Number of participants with hospitalizations for medical reasons will be reported.
Number of Participants with Other Serious Adverse Events (SAEs)
Time frame: Up to 1 year
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.
Number of Participants with Deaths
Time frame: Up to 1 year
Number of participants with deaths will be reported.
Number of Participants with Suicide Attempts and Completed Suicides
Time frame: Up to 1 year
Number of participants with suicide attempts and completed suicides will be reported.
Suicidality Assessment Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: Up to 1 year
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.
Number of Participants with Suicidal Ideation as Assessed by C-SSRS
Time frame: Up to 1 year
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.
12 secondary outcomes
Number of Participants with Adverse Events of Special Interest (AESI)
Time frame: Up to 1 year
Change from Baseline in Weight Over Time
Time frame: Baseline (Week 1) up to 1 year
Percentage of Participants with Clinically Meaningful Change in Weight
Time frame: Baseline (Week 1) to end of study (up to 1 Year)
Change from Baseline in Hemoglobin Level Over Time
Time frame: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Platelet and White Blood Cell (WBC) Count Over Time
Time frame: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Hematocrit Level Over Time
Time frame: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Red Blood Cell (RBC) Count Over Time
Time frame: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Sodium, Potassium, Chloride and Bicarbonate Level Over Time
Time frame: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Blood Urea Nitrogen (BUN), Creatinine, Glucose, Total and Direct Bilirubin, Calcium and Phosphate Level Over Time
Time frame: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase Level Over Time
Time frame: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Albumin and Total Protein Level Over Time
Time frame: Baseline (Week 1), Week 26 and Week 52
Change from Baseline in Total Cholesterol, Low-density Lipoprotein Cholesterol, Triglycerides, High-density Lipoprotein Cholesterol Level Over Time
Time frame: Baseline (Week 1), Week 26 and Week 52
Results and safety
The study was stopped early (reason given: due to business reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major, run by Janssen Research & Development, LLC at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: due to business reasons.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Spontaneously Reported Adverse Events (AEs) (time frame: Up to 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.