- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05109195
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
November 7, 2023 updated by: Janssen Research & Development, LLC
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
7
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Oxford, United Kingdom, OX3 7JX
- Warneford Hospital
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California
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San Francisco, California, United States, 94143
- University of California San Francisco
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Brigham & Women's Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15260
- The University of Pittsburgh of the Commonwealth System of Higher Education
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
The study population will consists of participants who will have one of the augmenting agents started.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Participants will not receive any intervention as a part of this study.
Participants will receive SOC treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Spontaneously Reported Adverse Events (AEs)
Time Frame: Up to 1 year
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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.
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Up to 1 year
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Number of Participants with AEs Collected through Generic Assessment of Side Effects (GASE)
Time Frame: Up to 1 year
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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.
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Up to 1 year
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Number of Participants with Hospitalization for Psychiatric Reasons
Time Frame: Up to 1 year
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Number of participants with hospitalizations for psychiatric reasons will be reported.
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Up to 1 year
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Number of Participants with Hospitalization for Medical Reasons
Time Frame: Up to 1 year
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Number of participants with hospitalizations for medical reasons will be reported.
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Up to 1 year
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Number of Participants with Other Serious Adverse Events (SAEs)
Time Frame: Up to 1 year
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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.
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Up to 1 year
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Number of Participants with Deaths
Time Frame: Up to 1 year
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Number of participants with deaths will be reported.
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Up to 1 year
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Number of Participants with Suicide Attempts and Completed Suicides
Time Frame: Up to 1 year
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Number of participants with suicide attempts and completed suicides will be reported.
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Up to 1 year
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Suicidality Assessment Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time Frame: Up to 1 year
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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.
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Up to 1 year
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Number of Participants with Suicidal Ideation as Assessed by C-SSRS
Time Frame: Up to 1 year
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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.
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Up to 1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants with Adverse Events of Special Interest (AESI)
Time Frame: Up to 1 year
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Number of participants with AESI: Cataplexy, Sleep paralysis, Complex sleep-related behaviors, Falls, Motor vehicle accidents will be reported.
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Up to 1 year
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Change from Baseline in Weight Over Time
Time Frame: Baseline (Week 1) up to 1 year
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Change from baseline in weight over time will be reported.
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Baseline (Week 1) up to 1 year
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Percentage of Participants with Clinically Meaningful Change in Weight
Time Frame: Baseline (Week 1) to end of study (up to 1 Year)
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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.
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Baseline (Week 1) to end of study (up to 1 Year)
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Change from Baseline in Hemoglobin Level Over Time
Time Frame: Baseline (Week 1), Week 26 and Week 52
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Change from baseline in hemoglobin level over time will be reported.
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Baseline (Week 1), Week 26 and Week 52
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Change from Baseline in Platelet and White Blood Cell (WBC) Count Over Time
Time Frame: Baseline (Week 1), Week 26 and Week 52
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Change from baseline in platelet and WBC count with differential over time will be reported.
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Baseline (Week 1), Week 26 and Week 52
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Change from Baseline in Hematocrit Level Over Time
Time Frame: Baseline (Week 1), Week 26 and Week 52
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Change from baseline in hematocrit level over time will be reported.
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Baseline (Week 1), Week 26 and Week 52
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Change from Baseline in Red Blood Cell (RBC) Count Over Time
Time Frame: Baseline (Week 1), Week 26 and Week 52
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Change from baseline in RBC count over time will be reported.
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Baseline (Week 1), Week 26 and Week 52
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Change from Baseline in Sodium, Potassium, Chloride and Bicarbonate Level Over Time
Time Frame: Baseline (Week 1), Week 26 and Week 52
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Change from baseline in sodium, potassium, chloride and bicarbonate level over time will be reported.
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Baseline (Week 1), Week 26 and Week 52
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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
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Change from baseline in BUN, creatinine, glucose, total and direct bilirubin, calcium and phosphate level over time will be reported.
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Baseline (Week 1), Week 26 and Week 52
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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
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Change from baseline in AST, ALT, alkaline phosphatase level over time will be reported.
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Baseline (Week 1), Week 26 and Week 52
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Change from Baseline in Albumin and Total Protein Level Over Time
Time Frame: Baseline (Week 1), Week 26 and Week 52
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Change from baseline in albumin and total protein level over time will be reported.
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Baseline (Week 1), Week 26 and Week 52
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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
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Change from baseline in total cholesterol, low-density lipoprotein cholesterol (calculated), triglycerides, high-density lipoprotein cholesterol level over time will be reported.
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Baseline (Week 1), Week 26 and Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 26, 2021
Primary Completion (Actual)
October 19, 2022
Study Completion (Actual)
October 19, 2022
Study Registration Dates
First Submitted
October 26, 2021
First Submitted That Met QC Criteria
October 26, 2021
First Posted (Actual)
November 5, 2021
Study Record Updates
Last Update Posted (Actual)
November 8, 2023
Last Update Submitted That Met QC Criteria
November 7, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR109066
- 42847922MDD3009 (Other Identifier: Janssen Research & Development, LLC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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