Treatment-resistant Depression
Conditions
Interventions
Intranasal Esketamine plus Oral Antidepressant Group
Approximately 148 eligible participants will be randomly assigned in a ratio of 1: 1 (n = 74 per treatment arm) to receive double-blind intranasal treatment with escetamine [28 mg, 56 mg or 84 mg] or
Drug
Sponsors
Clinica Dr. Norton Sayeg Ltda. EPP
Janssen-Cilag Farmacêutica Ltda.
Eligibility
Age
65 Years to No maximum
Inclusion criteria
Inclusion criteria: Study population will include older men and women, 65 years of age (inclusive) and above, meeting the Manual of diagnostic criteria Diagnostic and Statistical of Mental Disorders (5th edition, DSM-5) for single episode of MDD (if MDD single episode, the duration shall be 2 years) or MDD recurrent without psychotic features, based on clinical assessment and confirmed by the International Mini Neuropsychiatric Interview (MINI). In addition, the research participant must have a total score of Inventory Symptomatology Depressiva Evaluated by Medical 30 items (IDS-C30) of 34, which corresponds to moderate depression severa.No early screening / prospective observational phase, research participants should be submitted no response to 2, but 5, oral antidepressant treatments administered at an appropriate dose and a suitable duration, as assessed using the response Questionnaire Treatment antidepressant - Massachusetts General Hospital (MGH-ATRQ) and documented by medical history and pharmacy records / prescription for the current episode of depression. At the start of screening / prospective observational phase, the research participant must be one of those currently taking antidepressant treatments with non-major depressive episode documentada.O response current research participant and the treatment response to antidepressant treatments used in the present depressive episode ( assessed retrospectively) should be considered valid for participation in a clinical trial based on a Qualification Assessment Centre Independent. The Qualification Assessment Centre Independent is a tool to facilitate the selection of research participants for clinical studies of MDD, with a goal to ensure the inclusion of research participants that reflect the current state of disease, and that these symptoms can be measured reliably with appropriate measuring tools
Exclusion criteria
Exclusion criteria: Potential research participants will be excluded from participation in the study if they have previously shown no response of depressive symptoms to escetamina or ketamine in the current major depressive episode, all four options oral antidepressant treatment available for the phase double-blind induction (ie, duloxetine, escitalopram, sertraline and venlafaxine XR) a larger current depressive episode (based on MGHATRQ), or an appropriate course of treatment with electroconvulsive therapy (ECT) in the current major depressive episode, defined as at least 7 treatments with unilateral ECT. Research participants who currently have an implant to vagal nerve stimulation (VNS) or who received deep brain stimulation (DBS) in this major depressive episode will be deleted. Survey participants will also be excluded if they have a DSM-5 diagnostic current or previous a psychotic or MDD disorder with psychosis, bipolar and related disorders (confirmed by MINI), obsessive compulsive disorder comorbid, neurodegenerative disorder (eg., Disease Alzheimer's disease, vascular dementia, Parkinson's disease) or mild cognitive impairment evidence (MCI), a score of the Mini-Mental State Examination (MMSE) <25, STOP-Bang questionnaire score of 5, intellectual disability (only DSM-5 diagnostic code 319), borderline personality disorder, antisocial personality disorder, histrionic personality disorder or narcissistic personality disorder; if they presented ideation / intent homicidal or suicidal ideation with any intention to act within 6 months before the start of the phase of screening / prospective observational according to the clinical judgment of the investigator and / or based on Suicide Severity Rating Scale Columbia (C-SSRS); or have a history of disorder or substance use moderate or severe alcohol according to the DSM-5.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy endpoint will be the total MADRS score at the end of double-blind induction phase. The evaluation of MADRS be performed by remote independent evaluators during the study. The MADRS is a range evaluated by the physician designed to measure the severity of depression and detect changes due to antidepressant treatment. The MADRS evaluates apparent sadness, declared sadness, inner tension, sleep, appetite, concentration, tiredness, level of interest, pessimistic thoughts and suicidal thoughts. | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline change in total score on the Health Questionnaire Patient 9 items (PHQ-9) at the end of double-blind induction phase. The PHQ-9 is an outcome measure reported by the patient that will be used to assess depressive symptoms. The scale scores each of the 9 domains major symptoms DSM-5.Escores MDD criteria indicate greater severity in depressive symptoms;;Baseline change in total score on the Sheehan Disability Scale (SDS) at the end of double-blind Phase Induction. The SDS is an outcome measure and it is a questionnaire of 5 items that have been widely used and accepted for functional impairment assessment and associated disability;;Baseline change in score on the Clinical Impression Globally Severity (CGI-S) at the end of double-blind induction phase. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering the overall clinical experience, the participant is evaluated on the severity of mental illness at the time of evaluation. The CGI-S allows an overall assessment of the participant's condition at any given time;;Baseline change in life and health quality related to participant-reported health assessed by EuroQol-5 Dimension-5 level (EQ-5D-5L) at the end of double-blind induction phase. The EQ-5D-5L is a standardized instrument for use as a health outcome measure, designed primarily for self-completion by respondents. It consists of the descriptive system EQ-5D-5L and visual analog scale EQ (EQ-VAS). The system description may be represented as a state of health. Self-assessment EQVAS records the assessment of the respondent's general state of health itself at the conclusion, on a scale from 0 to 100 | — |
Countries
Belgium, Brazil, France, Italy, Poland, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactVinicius Righi
Janssen-Cilag Farmacêutica Ltda.
Outcome results
None listed