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    Summary
    EudraCT Number:2015-003578-34
    Sponsor's Protocol Code Number:54135419TRD3008
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-07-28
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2015-003578-34
    A.3Full title of the trial
    An Open-label Long-term Extension Safety Study of Intranasal Esketamine in Treatment resistant Depression
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Long-term Safety Study of Intranasal Esketamine in Treatment-resistant Depression
    A.3.2Name or abbreviated title of the trial where available
    SUSTAIN-3
    A.4.1Sponsor's protocol code number54135419TRD3008
    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.1.3.4CountryBelgium
    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 Research and Development
    B.4.2CountryUnited States
    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 AddressJanssen Biologics BV - Clinical Registry Group - Archimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.6E-mailClinicalTrialsEU@its.jnj.com
    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 No
    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.3.1Product nameEsketamine - Nasal Solution - eq 140mg/mL esketamine base (eq 161.4 mg/mL esketamine HCl)
    D.3.4Pharmaceutical form Nasal spray, solution
    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 Esketamine (for (S)-2-(o-chlorophenyl)-2-(methylamino)cyclohexanone)
    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 number140
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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 Depression
    E.1.1.1Medical condition in easily understood language
    Depression is a mental disorder characterized by low mood and/or loss
    of interest or pleasure in nearly all activities.
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10057840
    E.1.2Term Major depression
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the safety and tolerability of intranasal esketamine in subjects with TRD, with special attention to the following:
    •Potential long term effects on cognitive function
    •Treatment-emergent adverse events (TEAEs), including TEAEs of special interest
    •Post dose effects on heart rate, blood pressure, respiratory rate and blood oxygen saturation
    •Potential effects on suicidal ideation/behavior
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess long-term efficacy, including effects on:
    •Depressive symptoms (clinician and self-reported),
    •Overall severity of depressive illness,
    •Functioning and associated disability,
    •Health related quality of life and health status
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Based on the prior study the participant is entering 54135419TRD3008 from: a) From ESKETINTRD3001 (NCT02417064) or
    ESKETINTRD3002 (NCT02418585) study: Participant has completed the induction phase and 6-month follow up phase;
    b) From ESKETINTRD3003 (NCT02493868) study: (1) Participant relapsed during the maintenance phase; or (2) Participant was in the induction phase of the ESKETINTRD3003 study when the study was terminated and, after completion of the induction phase, was determined to be a responder; or (3) Participant was in the optimization or maintenance phases at the time the study was terminated;
    c) From ESKETINTRD3004 (NCT02497287) study: (1) Participant completed the
    ESKETINTRD3004 study (that is, Week 52 of the optimization/maintenance phase and the follow up phase); or (2) Participant was in the induction phase of the ESKETINTRD3004 study when the study was terminated and, after completion of the induction phase, was determined to be a responder; or (3) Participant was in the optimization/maintenance phase at the time the study was terminated;
    d) From ESKETINTRD3005 (NCT02422186) study: Participant was in the induction phase of the ESKETINTRD3005 study at the time enrollment into the ESKETINTRD3004 study was closed and, after completion of the induction phase, was determined to be a responder or a non-responder.
    -Participant must be medically stable on the basis of physical examination, vital signs, pulse oximetry, and 12-lead Electrocardiogram (ECG) performed
    predose on the day of the first intranasal treatment session. If there are any
    abnormalities that are not specified in the inclusion and exclusion criteria, their
    clinical significance must be determined by the investigator and recorded in the participant's source documents and initialed by the investigator
    -Participant must be medically stable on the basis of clinical laboratory tests performed predose on the day of the first intranasal treatment session. If the results of the serum chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initialed by the investigator
    -A woman of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [b-hCG]) predose on the day of the first intranasal treatment session
    -During the study (that is, from the first intranasal treatment session) and for a
    minimum of 1 spermatogenesis cycle (defined as approximately 90 days) after
    receiving the last dose of intranasal study medication, in addition to the user
    independent highly effective method of contraception, a man a) who is sexually active with a woman of childbearing potential must agree to use a doublebarrier method of contraception (example, diaphragm or cervical/vault caps plus condom with spermicidal foam/gel/film/cream/suppository); b) who is sexually active with a woman who is pregnant must use a condom; c) must
    agree not to donate sperm. Alternatively female partners of childbearing potential may be practicing a highly effective method of birth control, example, established use of oral, injected, or implanted hormonal methods of
    contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); or male partner sterilization.
    E.4Principal exclusion criteria
    -The evaluation of the benefit versus risk of continued intranasal esketamine treatment is not favorable for the participant in the opinion of the investigator
    -Since the last study visit in the participant’s prior study, participant has
    suicidal ideation with intent to act per the investigator’s clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS) [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) in the suicidal ideation module of the C-SSRS] or suicidal behavior per the investigator’s clinical judgment or based on the C-SSRS (corresponding to any score higher than 0 in the suicidal behavior module of the C-SSRS)
    -Participant has positive test result(s) for drugs of abuse (including arbiturates,
    methadone, opiates, cocaine, phencyclidine, and amphetamine/methamphetamine) predose on the day of the first intranasal treatment session
    -Participant has any anatomical or medical condition that, per the investigator’s clinical judgment based on assessment, may impede delivery or
    absorption of intranasal study drug
    -Participant has taken any prohibited therapies that would not permit
    administration of the first intranasal treatment session
    E.5 End points
    E.5.1Primary end point(s)
    1.) Number of Participants With Treatment Emergent Adverse Events (TEAEs)
    2.) Change From Baseline in Systolic and Diastolic Blood Pressure
    3.) Change From Baseline in Heart Rate
    4.) Change From Baseline in Blood Oxygen Saturation
    5.) Change From Baseline in Modified Observer's Assessment of Alertness/Sedation (MOAAS) Scale Score
    6.) Change from Baseline in Electrocardiogram (ECG) intervals
    7.) Change From Baseline in Computerized Cognitive Battery Domain Score and Hopkins Verbal Learning Test-Revised (HVLT-R) Score
    8.) Change From Baseline in Columbia-Suicide Severity Rating Scale (CSSRS)
    Score
    9.) Changes From Baseline Over Time in Clinical Laboratory Tests
    10.) Time to Discharge Readiness Using the Clinical Global Assessment of
    Discharge Readiness (CGADR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.) Up to End of Study (approximately 5 years 3 months)

    2./3./4./6.) Baseline of each dosing session (predose) up to the last post-dose measurement from the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)

    5.) 1 hour post-dose from the start of Induction Phase to End of
    Optimization/Maintenance Phase (approximately 5 years 3 months)

    7./8./9./10.) From the start of Induction Phase to End of Optimization/Maintenance Phase (approximately 5 years 3 months)
    E.5.2Secondary end point(s)
    1.) Change From Baseline in Participant-Reported Depressive Symptoms Using the Patient Health Questionnaire - 9 (PHQ-9) Total Score
    2.) Change From Baseline in Clinical Global Impression-Severity (CGI-S)
    score
    3.) Change From Baseline in Participant-Reported Functioning and Associated Disability as Assessed by the Sheehan Disability Scale (SDS) Total Score
    4.) Change From Baseline in Participant-Reported Health-related Quality of Life and Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L)
    5.) Change From Baseline in Participant- Reported Health Related Quality of Life Using the Quality of Life in Depression Scale (QLDS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1./2./3./4./5.) From the start of Induction Phase to End of Optimization/Maintenance
    Phase (approximately 5 years 3 months)
    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 Yes
    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 No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA105
    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
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Korea, Republic of
    Malaysia
    Mexico
    Poland
    Romania
    South Africa
    Spain
    Sweden
    Taiwan
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days19
    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: 300
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 114
    F.4.2.2In the whole clinical trial 330
    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)
    NA
    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 Decision2016-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-12-30
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