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    EudraCT Number:2020-004291-18
    Sponsor's Protocol Code Number:54135419TRD4010
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-18
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-004291-18
    A.3Full title of the trial
    Open-label Long-Term Extension Study for Participants With Treatment-Resistant Major Depressive Disorder Who are Continuing Esketamine Nasal Spray Treatment From Study 54135419TRD3013
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-label Extension Study to Assess Long-term Safety of Esketamine Nasal Spray for Participants Who are Continuing Treatment From Study 54135419TRD3013
    A.4.1Sponsor's protocol code number54135419TRD4010
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International NV
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Pharmaceutica NV
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D. name Spravato
    D. of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEsketamine
    D.3.9.2Current sponsor codeJNJ-54135419
    D.3.9.3Other descriptive nameESKETAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB25811
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number161.4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment-Resistant Major Depressive Disorder
    E.1.1.1Medical condition in easily understood language
    Major Depressive Disorder
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10081270
    E.1.2Term Major depressive disorder
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    -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
    E.2.3Trial contains a sub-study No
    E.3Principal 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 <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.
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    Intervention-emergent AEs, including intervention-emergent AEs of special interest. Suicidal ideation and behavior: Columbia-Suicide Severity Rating Scale (C-SSRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study.
    E.5.2Secondary 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

    E.5.2.1Timepoint(s) of evaluation of this end point
    1./2./3./4./5. Up to Week 104 visit (or end -of-study-visit)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA95
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Korea, Republic of
    South Africa
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 122
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 81
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 203
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-16
    P. End of Trial
    P.End of Trial StatusCompleted
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