Treatment-resistant Depression
Conditions
Interventions
Intranasal escetamine 56 mg plus oral antidepressant
112 participants
twice weekly for 4 weeks as a fixed dose schedule
Intranasal escetamine 84 mg plus oral antidepressant
Placebo escetamina intranasal plus oral antidepressant
Drug
Sponsors
Centro De Psiquiatria E Pesquisas Sandra Ruschel Ltda
Janssen-Cilag Farmacêutica Ltda.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: man or woman 18 years old (or older if the minimum legal age of consent in the country in which the study is taking place is greater than [>]18) to 64 years of age; meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria for single-episode major depressive disorder (MDD) (if single-episode MDD the duration must be greater than or equal to [>=] 2 years) or recurrent MDD without psychotic features based upon clinical assessment and confirmed by the Mini-International Neuropsychiatric Interview (MINI); At the start of the screening/prospective observational phase; participants must have had nonresponse to >=2 but less than or equal to (=) 34; The participant’s current major depressive episode and treatment response to antidepressant treatments used in the current depressive episode (retrospectively assessed) must be deemed valid for participation in a clinical study based on a Site-Independent Qualification Assessment
Exclusion criteria
Exclusion criteria: Participants who have previously demonstrated nonresponse of depressive symptoms to esketamine or ketamine in the current major depressive episode. to all 4 of the oral antidepressant treatment options available for the double-blind induction phase (i.e. duloxetine. escitalopram. sertraline. and venlafaxine extended release [XR]) in the current major depressive episode (based on MGH-ATRQ) or an adequate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode defined as at least 7 treatments with unilateral ECT; Participant currently has an implant for vagal nerve stimulation (VNS) or has received deep brain stimulation (DBS) in the current episode of depression; Participant has a current or prior DSM-5 diagnosis of a psychotic disorder or MDD with psychosis. bipolar or related disorders (confirmed by the MINI). comorbid obsessive compulsive disorder. intellectual disability (only DSM-5 diagnostic code 319). borderline personality disorder. antisocial personality disorder. histrionic personality disorder. or narcissistic personality disorder; Participant has homicidal ideation/intent per the investigator’s clinical judgment or has suicidal ideation with some intent to act within 6 months prior to the start of the screening prospective observational phase per the investigator’s clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS); Participants with history of moderate or severe substance or alcohol use disorder according to DSM-5 criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at End of Double-blind Induction Phase | — |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Subject-reported Depressive Symptoms Using the Patient Health Questionnaire-9 (PHQ-9) Total Score at End of Double-blind Induction Phase; Onset of Clinical Response That Continued from Day 2 Through the End of the 4-week Doubleblind Induction Phase; Change From Baseline in Subject-reported Functioning and Associated Disability as Assessed by the Sheehan Disability Scale (SDS) Total Score at End of Double-blind Induction Phase; Change From Baseline in Clinical Global Impression – Severity (CGI-S) Score at End of Double-blind Induction Phase; Change From Baseline in Subject-reported Generalized Anxiety Disorder (GAD-7) Total Score at End of Doubleblind Induction Phase; Change From Baseline in Subject-reported Healthrelated Quality of Life and Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) at End of Double-blind Induction Phase | — |
Countries
Belgium, Brazil, Canada, France, Japan, Mexico, United States
Contacts
Public ContactVinicius Righi
Janssen-Cilag Farmacêutica Ltda.
Outcome results
None listed