Open-label Extension Study to Assess Long-term Safety of Esketamine Nasal Spray for Participants Who are Continuing Treatment From Study 54135419TRD3013
- Conditions
- Treatment-Resistant Major Depressive DisorderMedDRA version: 21.1Level: LLTClassification code 10081270Term: Major depressive disorderSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2020-004291-18-PL
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 203
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 <1% per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study intervention and until at least 6 weeks after last dose - the end of relevant systemic exposure. The investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention. Examples of highly effective methods of contraception are located in Appendix 2, Contraceptive and Barrier.
7. Male participants who are sexually active with a woman of childbearing potential must agree to the following during the intervention period and for at least 1 spermatogenesis cycle (defined as approximately 90 days) after receiving the last dose of study intervention (ie, esketamine nasal spray), must fulfill the following criteria:
•must be practicing a highly effective method of contraception with his female partner.
•must use a condom if his partner is pregnant.
•must agree not to donate sperm.
Note: If the childbearing potential changes after start of the study, a female partner of a male study participant, must begin a highly effective method of birth control, as described above. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies.
8. Willing and able to adhere to the lifestyle restrictions specified in this protocol.
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 122
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 81
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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).<br>-To assess the effect of esketamine nasal spray in combination with an SSRI/SNRI on:<br>Clinician-rated overall severity of depressive illness<br>-Participant-reported depressive symptoms<br>-Participant-reported health-related quality of life and health status<br>;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).<br>;Timepoint(s) of evaluation of this end point: Throughout the study.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1.) No relapse. For definition of relapse see section 3 of protocol.<br>2.) Change from baseline in Study TRD3013 at all visits for the following scale scores:<br>•Clinician-rated MADRS:<br>-Overall severity of depressive illness (total score)<br>-Depressive symptoms (individual items)<br>3.) Clinician-rated overall severity of depressive illness: <br>-Clinical Global Impression – Severity (CGI S)<br>4.) Participant-reported depressive symptoms: Patient Health Questionnaire 9-item (PHQ 9)<br>5.) Participant-reported European Quality of Life (EuroQoL) Group, 5 Dimension, 5-Level (EQ 5D-5L) questionnaire<br><br>;Timepoint(s) of evaluation of this end point: 1./2./3./4./5. Up to Week 104 visit (or end -of-study-visit)