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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 4
- 主要终点
- Number of Participants with Hospitalization for Medical Reasons
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of Participants with Hospitalization for Medical Reasons
时间窗: Up to 1 year
Number of participants with hospitalizations for medical reasons will be reported.
Number of Participants with Hospitalization for Psychiatric Reasons
时间窗: Up to 1 year
Number of participants with hospitalizations for psychiatric reasons will be reported.
Number of Participants with Deaths
时间窗: Up to 1 year
Number of participants with deaths will be reported.
Number of Participants with Suicide Attempts and Completed Suicides
时间窗: Up to 1 year
Number of participants with suicide attempts and completed suicides will be reported.
Number of Participants with AEs Collected through Generic Assessment of Side Effects (GASE)
时间窗: 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 Spontaneously Reported Adverse Events (AEs)
时间窗: 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 Other Serious Adverse Events (SAEs)
时间窗: 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.
Suicidality Assessment Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score
时间窗: 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
时间窗: 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.
次要结局
- Number of Participants with Adverse Events of Special Interest (AESI)(Up to 1 year)
- Change from Baseline in Hemoglobin Level Over Time(Baseline (Week 1), Week 26 and Week 52)
- Change from Baseline in Red Blood Cell (RBC) Count Over Time(Baseline (Week 1), Week 26 and Week 52)
- Change from Baseline in Weight Over Time(Baseline (Week 1) up to 1 year)
- Change from Baseline in Platelet and White Blood Cell (WBC) Count Over Time(Baseline (Week 1), Week 26 and Week 52)
- Percentage of Participants with Clinically Meaningful Change in Weight(Baseline (Week 1) to end of study (up to 1 Year))
- Change from Baseline in Sodium, Potassium, Chloride and Bicarbonate Level Over Time(Baseline (Week 1), Week 26 and Week 52)
- Change from Baseline in Albumin and Total Protein Level Over Time(Baseline (Week 1), Week 26 and Week 52)
- Change from Baseline in Hematocrit Level Over Time(Baseline (Week 1), Week 26 and Week 52)
- Change from Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase Level Over Time(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(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(Baseline (Week 1), Week 26 and Week 52)