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
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Depressive Disorder, Major
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-11-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consists of participants who will have one of the augmenting agents started.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with Spontaneously Reported Adverse Events (AEs)
timeFrame: Up to 1 year
measure: Number of Participants with AEs Collected through Generic Assessment of Side Effects (GASE)
timeFrame: Up to 1 year
measure: Number of Participants with Hospitalization for Psychiatric Reasons
timeFrame: Up to 1 year
measure: Number of Participants with Hospitalization for Medical Reasons
timeFrame: Up to 1 year
measure: Number of Participants with Other Serious Adverse Events (SAEs)
timeFrame: Up to 1 year
measure: Number of Participants with Deaths
timeFrame: Up to 1 year
measure: Number of Participants with Suicide Attempts and Completed Suicides
timeFrame: Up to 1 year
measure: Suicidality Assessment Using the Columbia Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: Up to 1 year
measure: Number of Participants with Suicidal Ideation as Assessed by C-SSRS
timeFrame: Up to 1 year
Secondary outcomes:
measure: Number of Participants with Adverse Events of Special Interest (AESI)
timeFrame: Up to 1 year
measure: Change from Baseline in Weight Over Time
timeFrame: Baseline (Week 1) up to 1 year
measure: Percentage of Participants with Clinically Meaningful Change in Weight
timeFrame: Baseline (Week 1) to end of study (up to 1 Year)
measure: Change from Baseline in Hemoglobin Level Over Time
timeFrame: Baseline (Week 1), Week 26 and Week 52
measure: Change from Baseline in Platelet and White Blood Cell (WBC) Count Over Time
timeFrame: Baseline (Week 1), Week 26 and Week 52
measure: Change from Baseline in Hematocrit Level Over Time
timeFrame: Baseline (Week 1), Week 26 and Week 52
measure: Change from Baseline in Red Blood Cell (RBC) Count Over Time
timeFrame: Baseline (Week 1), Week 26 and Week 52
measure: Change from Baseline in Sodium, Potassium, Chloride and Bicarbonate Level Over Time
timeFrame: Baseline (Week 1), Week 26 and Week 52
measure: Change from Baseline in Blood Urea Nitrogen (BUN), Creatinine, Glucose, Total and Direct Bilirubin, Calcium and Phosphate Level Over Time
timeFrame: Baseline (Week 1), Week 26 and Week 52
measure: Change from Baseline in Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Alkaline Phosphatase Level Over Time
timeFrame: Baseline (Week 1), Week 26 and Week 52
measure: Change from Baseline in Albumin and Total Protein Level Over Time
timeFrame: Baseline (Week 1), Week 26 and Week 52
measure: Change from Baseline in Total Cholesterol, Low-density Lipoprotein Cholesterol, Triglycerides, High-density Lipoprotein Cholesterol Level Over Time
timeFrame: Baseline (Week 1), Week 26 and Week 52
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Boston
country: United States
facility: Brigham And Women's Hospital
state: Massachusetts
city: Pittsburgh
country: United States
facility: The University of Pittsburgh of the Commonwealth System of Higher Education
state: Pennsylvania
city: Oxford
country: United Kingdom
facility: Warneford Hospital
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: