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    EudraCT Number:2019-001683-29
    Sponsor's Protocol Code Number:61393215MDD2001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-08-19
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2019-001683-29
    A.3Full title of the trial
    Double-Blind, Placebo-Controlled, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-61393215 as Adjunctive Treatment in Adults with Major Depressive Disorder with Anxious Distress with Suboptimal Response to Standard Antidepressants
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to explore the efficacy JNJ-61393215 in the treatment of depression
    A.4.1Sponsor's protocol code number61393215MDD2001
    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 Research and Development, LLC
    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 AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.4Telephone number+31(0)71 524 21 66
    B.5.5Fax number+31(0)71 524 21 10
    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 nameJNJ-61393215, 45-mg
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.1CAS number 1637681-55-0
    D.3.9.3Other descriptive nameJNJ-61393215-AAA
    D.3.9.4EV Substance CodeSUB182276
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number45
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adjunctive Treatment in Adults with Major Depressive Disorder with Anxious Distress with Suboptimal Response to Standard Antidepressants
    E.1.1.1Medical condition in easily understood language
    Major depression with anxiety
    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 10025453
    E.1.2Term Major depressive disorder NOS
    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
    The primary objective of this study is to evaluate the efficacy of JNJ 61393215 as adjunctive treatment compared to adjunctive placebo, as assessed by the change from baseline to Week 6 on a 17-item Hamilton Depression Rating Scale (HDRS17) in participants with MDD with anxious distress with a score ≥ 2 on item 26 or 27 of the Inventory of Depressive Symptomatology, Clinician Rating -30 (IDS-C30), who have a suboptimal response to current treatment with a standard antidepressant.
    E.2.2Secondary objectives of the trial
    The key secondary objective is to evaluate the impact of adjunctive treatment with JNJ-61393215 compared to adjunctive placebo on the severity of anxiety as measured by the change in the Hamilton Anxiety Rating scale (HAM-A) from baseline to Week 6.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female participants between 18 and 64 years of age, inclusive.
    2. Participants must have a primary DSM-5 diagnosis of MDD with anxious distress, as assessed by the MINI 7.0. Plus (with module for MDD with anxious distress). Participants with a diagnosis of comorbid Generalized Anxiety Disorder (GAD), Post Traumatic Stress Disorder, Persistent Depressive Disorder, Attention Deficit Hyperactivity Disorder (ADHD), Social Anxiety Disorder or Nicotine/Caffeine Dependence may be included, if the investigator considers MDD to be the primary diagnosis. Participants with Panic Disorder with or without agoraphobia may be included if the Panic Disorder diagnosis is primary.
    3. Participants must have an IDS-C30 total score ≥35 (moderate to severe depression) at screening, as confirmed by the SAFER independent rater.
    4. Participant must have an IDS-C30 score for item 26 or 27 (symptoms of somatic anxiety) ≥2 at screening, as confirmed by the SAFER independent rater.
    5. Participant must not have received more than 3 failed antidepressant treatments (of adequate dose and duration), including their current treatment, in the current episode of depression, as documented by the MGH ATRQ.

    Please see protocol for remaining inclusion criteria.
    E.4Principal exclusion criteria
    1. Participant has any other current Axis I psychiatric condition, including, but not limited to, MDD with current psychotic features, bipolar disorder (including lifetime diagnosis), obsessive compulsive disorder, borderline personality disorder, eating disorder (e.g., bulimia, anorexia nervosa), or schizophrenia (lifetime). As noted above, participants with a diagnosis of comorbid GAD, Post Traumatic Stress Disorder, Persistent Depressive Disorder, ADHD, Social Anxiety Disorder, or Nicotine/Caffeine Dependence may be included, if the investigator considers MDD to be the primary diagnosis. Participants with Panic Disorder with or without agoraphobia may be included if the Panic Disorder diagnosis is primary.
    2. Participant has an age of onset of depression after 55 years of age.
    3. Participant has a current or recent (within the past year) history of clinically significant suicidal ideation (corresponding to a score of ≥ 3 for ideation) or any suicidal behavior within the past year, as validated on the C-SSRS at screening or baseline. Participants with a prior suicide attempt of any sort, or history of prior serious suicidal ideation/plan should be carefully screened for current suicidal ideation and only included at the discretion of the investigator.
    4. Length of current major depressive episode > 60 months.
    5. Participant has organic brain disease or dementia.

    Please see protocol for remaining exclusion criteria.
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline to week 6 on a 17-item Hamilton Depression Rating Scale (HDRS17)
    E.5.1.1Timepoint(s) of evaluation of this end point
    HDRS17 at baseline and week 6.
    E.5.2Secondary end point(s)
    1. change in Hamilton anxiety scale (HAM-A) from baseline to weeks 2 and 4.
    2. the change from baseline to Week 6 on the HDRS17 in participants with a baseline HAM-A score ≥20.
    3. the change from baseline to Week 6 on the HAM-A in participants with a baseline HAM-A score ≥20
    4. the change in the General Anxiety Disorder-7 scale (GAD-7) from baseline to Week 6.
    5. the change in the Patient Health Questionnaire (PHQ-9) from baseline to weeks 2, 4 and 6.
    6. the change in HDRS17 from baseline to weeks 2 and 4.
    7. safety and tolerability of adjunctive treatment with JNJ-61393215
    8. plasma concentration of JNJ-61393215
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Baseline, week 2 and 4
    2. Baseline and week 6
    3. Baseline and week 6
    4. Baseline and week 6
    5. Baseline, week 2, week 4 and week 6
    6. Baseline, week 2 and week 4
    7. All visits
    8. baseline, 2, 4 and 6 weeks
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Biomarker
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    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
    Moldova, Republic of
    Russian Federation
    United Kingdom
    United States
    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 years1
    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 years1
    E.8.9.2In all countries concerned by the trial months8
    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: 218
    F.1.3Elderly (>=65 years) No
    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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 29
    F.4.2.2In the whole clinical trial 218
    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 Decision2019-09-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-26
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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