Treatment Resistant Major Depression MedDRA version: 19.0 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: Esketamine - Nasal Solution - eq 140
Pharmaceutical Form: Nasal spray
INN or Proposed INN: Esketamine Hydrochloride
Other descriptive name: ESKETAMINE HYDROCHLORIDE
Concentration unit: m
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient must meet Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition (DSM-5) diagnostic criteria for Major Depressive Disorder (MDD), without psychotic features, based upon clinical assessment, and confirmed by the Mini International Psychiatric Interview (MINI). - Patient's major depressive episode and treatment response must be deemed "valid" by remote independent raters - Patient must have had an inadequate response to at least 2 antidepressants, at least one of which is in the current episode of depression. The ATRQ will be used to assess antidepressant treatment response during the current episode. Prior medication history will be used to determine antidepressant treatment response in prior episode(s) - Have an Inventory of Depressive Symptoms-Clinician rated, 30-item (IDS-C30) total score >=34 at Screening and predose at Day 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Patient has a current diagnosis of bipolar and related disorders, intellectual disability, or cluster b personality disorder (e.g., borderline personality disorder, antisocial personality disorder, histrionic personality disorder, and narcissistic personality disorder) - Patient has a current or prior diagnosis of a psychotic disorder or MDD with psychosis - Anatomical or medical conditions that may impede delivery or absorption of study medication (e.g., undergone facial reconstruction, significant structural or functional abnormalities of the nose or upper airway; obstructions or mucosal lesions of the nostrils or nasal passages; undergone sinus surgery in the previous 2 years; signs and symptoms of rhinitis) - Has an abnormal or deviated nasal septum with any 1 or more of the following symptoms: blockage of 1 or both nostrils, nasal congestion (especially 1-sided), frequent nosebleeds, frequent sinus infections, and at times has facial pain, headaches, and postnasal drip - Patient meets criteria for substance or alcohol use disorder, except tobacco or caffeine, according to DSM-5 criteria at Screening - Patient has known allergies, hypersensitivity, intolerance, or contraindication to esketamine/ketamine or its excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To evaluate sustained response (greater than or equal to 50% reduction from baseline in MADRS total score) with onset by Day 2 through the end of the double-blind phase (Day 15). 2. To investigate the safety and tolerability of intranasal esketamine in TRD subjects. 3. To assess the effect of intranasal esketamine compared to intranasal placebo on depressive symptoms, clinical severity of illness, anxiety symptoms, remission, and response. 4. To evaluate the pharmacokinetics (PK) of intranasal esketamine in subjects with TRD.;Main Objective: To assess the efficacy and dose response of intranasal esketamine compared with placebo in improving depressive symptoms in subjects with TRD;Primary end point(s): Change from baseline to the 1 week endpoint in Montgomery Asberg Depression Rating scale (MADRS) total score;Timepoint(s) of evaluation of this end point: (Day 1 predose, Day 8 predose) to (Day 8 predose, Day 15) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Proportion of patients with sustained response (>=50% reduction from baseline in MADRS total score) with onset by Day 2 through the end of the double-blind phase (Day 15) 2. Proportion of responders (>=50% reduction from baseline in MADRS total score) at each visit 3. Proportion of patients in remission (MADRS <=10) at each visit 4. Change from baseline to the 1-week endpoint in patient-reported depressive symptoms using the 16-item quick inventory of depressive symptoms - self report (QIDS-SR16) 5. Change from baseline to the 1-week endpoint in severity of illness using the Clinical Global Impression Severity (CGI-S) rating scale 6. Change from baseline to the 1-week endpoint in severity of illness using the patient global impression - severity (PGI-S) 7. Change from baseline to the 1-week endpoint in anxiety symptoms, as measured by the generalized anxiety disorder 7 item scale (GAD-7);Timepoint(s) of evaluation of this end point: 1. Day 2 to Day 15 2. Days 1, 2, 4, 8, 9, 11, 14, 15 3. Days 1, 2, 4, 8, 9, 11, 14, 15 4. Day 1 predose to day 8 predose; and day 8 predose to day 15 5. Day 1 predose to day 8 predose; and day 8 predose to day 15 6. Day 1 predose to day 8 predose; and day 8 predose to day 15 7. Day 1 predose to day 8 predose; and day 8 predose to day 15 | — |
Countries
Belgium, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed