Treatment-Resistant Major Depressive Disorder MedDRA version: 21.1 Level: LLT Classification code 10081270 Term: Major depressive disorder System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Spravato
Pharmaceutical Form: Nasal spray
INN or Proposed INN: Esketamine
Current Sponsor code: JNJ-54135419
Other descriptive name: ESKETAMINE HYDROCHLORIDE
Concentration unit: mg/ml mill
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Completed the maintenance phase (Week 32) of Study TRD3013 and had esketamine nasal spray in combination with continuing SSRI/SNRI administered through Week 30 (every 2 week dosing) or Week 31 (once weekly dosing) of Study TRD3013, and continues to be willing to be treated with esketamine nasal spray. 2. Must, in the opinion of the investigator, be benefiting from continuation of esketamine nasal spray in combination with their current SSRI/SNRI based on efficacy and tolerability assessed on Day 1 of this study. 3. Must be medically stable based on the investigator’s judgment. 4. Must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. 5. A woman of childbearing potential must have a negative urine pregnancy test on Day 1. 6. A woman must be (as defined in Appendix 2, Contraceptive and Barrier Guidance) a. Not of childbearing potential b. Of childbearing potential and -Practicing a highly effective, preferably user-independent method of contraception (failure rate of =65 years) yes F.1.3.1 Number of subjects for this age range 81
Exclusion criteria
Exclusion criteria: 1. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. 2. Completed Study TRD3013 while presenting adverse events deemed clinically relevant by the investigator, and which may interfere with safety and well-being of the participant. 3. Has developed during participation in Study TRD3013 any of the following cardiovascular-related conditions where an increase in blood pressure or intracranial pressure poses a serious risk: •cerebrovascular disease following stroke or transient ischemic attack. •aneurysmal vascular disease (including intracranial, thoracic, or abdominal aorta, or peripheral arterial vessels). •intracerebral hemorrhage. •coronary artery disease following myocardial infarction, unstable angina, or revascularization procedure (eg, coronary angioplasty or bypass graft surgery). •uncontrolled brady or tachyarrhythmias that lead to hemodynamic instability. •hemodynamically significant valvular heart disease such as mitral regurgitation, aortic stenosis, or aortic regurgitation or heart failure (NYHA Class III-IV) of any etiology. Significant pulmonary insufficiency, including chronic obstructive pulmonary disease 4. Has homicidal ideation or intent, per the investigator’s clinical judgment; or has suicidal ideation with some intent to act within 1 month prior to Day 1, per the investigator’s clinical judgment; or based on the C-SSRS performed at Week 32 visit of Study TRD3013, corresponding to a response of “Yes” on Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) for suicidal ideation. 5. Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the long-term safety and tolerability of esketamine nasal spray in combination with an SSRI/SNRI in participants who have completed 32 weeks of esketamine nasal spray treatment in Study TRD3013.;Secondary Objective: -To assess the long-term efficacy of esketamine nasal spray in combination with an SSRI/SNRI based on the proportion of participants being relapse-free at Week 104 (or end-of-study). -To assess the effect of esketamine nasal spray in combination with an SSRI/SNRI on: Clinician-rated overall severity of depressive illness -Participant-reported depressive symptoms -Participant-reported health-related quality of life and health status ;Primary end point(s): Intervention-emergent AEs, including intervention-emergent AEs of special interest. Suicidal ideation and behavior: Columbia-Suicide Severity Rating Scale (C-SSRS). ;Timepoint(s) of evaluation of this end point: Throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.) No relapse. For definition of relapse see section 3 of protocol. 2.) Change from baseline in Study TRD3013 at all visits for the following scale scores: •Clinician-rated MADRS: -Overall severity of depressive illness (total score) -Depressive symptoms (individual items) 3.) Clinician-rated overall severity of depressive illness: -Clinical Global Impression – Severity (CGI S) 4.) Participant-reported depressive symptoms: Patient Health Questionnaire 9-item (PHQ 9) 5.) Participant-reported European Quality of Life (EuroQoL) Group, 5 Dimension, 5-Level (EQ 5D-5L) questionnaire ;Timepoint(s) of evaluation of this end point: 1./2./3./4./5. Up to Week 104 visit (or end -of-study-visit) | — |
Countries
Belgium, Bulgaria, Czech Republic, Finland, Germany, Greece, Hungary, Korea, Republic of, Malaysia, Norway, Poland, South Africa, Taiwan, Turkey
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed