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 Type
OBSERVATIONAL
Enrollment
7
Participants will not receive any intervention as a part of this study. Participants will receive SOC treatment.
University of California San Francisco
San Francisco, California, United States
Brigham And Women's Hospital
Boston, Massachusetts, United States
The University of Pittsburgh of the Commonwealth System of Higher Education
Pittsburgh, Pennsylvania, United States
Warneford Hospital
Oxford, United Kingdom
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.
Time frame: 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.
Time frame: Up to 1 year
Number of Participants with Hospitalization for Psychiatric Reasons
Number of participants with hospitalizations for psychiatric reasons will be reported.
Time frame: Up to 1 year
Number of Participants with Hospitalization for Medical Reasons
Number of participants with hospitalizations for medical reasons will be reported.
Time frame: 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.
Time frame: Up to 1 year
Number of Participants with Deaths
Number of participants with deaths will be reported.
Time frame: Up to 1 year
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Number of Participants with Suicide Attempts and Completed Suicides
Number of participants with suicide attempts and completed suicides will be reported.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 year
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.
Time frame: Up to 1 year
Change from Baseline in Weight Over Time
Change from baseline in weight over time will be reported.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
Change from baseline in BUN, creatinine, glucose, total and direct bilirubin, calcium and phosphate level over time will be reported.
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
Change from baseline in AST, ALT, alkaline phosphatase level over time will be reported.
Time frame: 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.
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
Change from baseline in total cholesterol, low-density lipoprotein cholesterol (calculated), triglycerides, high-density lipoprotein cholesterol level over time will be reported.
Time frame: Baseline (Week 1), Week 26 and Week 52