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    EudraCT Number:2015-002007-29
    Sponsor's Protocol Code Number:42165279MDD2001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-09-20
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-002007-29
    A.3Full title of the trial
    A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-42165279 in Subjects with Major Depressive Disorder with Anxious Distress
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy, Safety and Tolerability Study of JNJ-42165279 in Participants with Major Depressive Disorder with Anxious Distress
    A.4.1Sponsor's protocol code number42165279MDD2001
    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 & 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 AddressJanssen Biologics BV - Clinical Registry Group- Archimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.4Telephone number+3171524 21 66
    B.5.5Fax number+3171524 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 nameJNJ42165279-AAA - tablet - 25 mg
    D.3.4Pharmaceutical form Tablet
    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 INNNot assigned
    D.3.9.1CAS number Not assigned
    D.3.9.3Other descriptive nameJNJ-42165279-AAA
    D.3.9.4EV Substance CodeSUB78465
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 placeboTablet
    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
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025453
    E.1.2Term Major depressive disorder NOS
    E.1.2System Organ Class 100000024349
    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 in terms of reduction of symptoms of depression and anxiety, as assessed by the change from baseline on a 17-item Hamilton Depression Rating Scale (HDRS17), and overall safety and tolerability of treatment with adjunctive JNJ-42165279 compared to placebo in subjects with MDD with anxiety symptoms who have had inadequate response to treatment with a selective serotonin reuptake inhibitor (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI).
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of JNJ-42165279 on core symptoms of anxiety (HAM-A6).
    • To assess the efficacy of JNJ-42165279 using dimensional analyses of both anxiety and depression (HDRS17 and SIGH-A).
    • To assess the efficacy of JNJ-42165279 on the response and remission of depressive and anxiety symptoms (derived from HDRS17 and SIGH-A).
    • To assess the plasma pharmacokinetic (PK) profile of JNJ-42165279 administered as once daily (qd) in male and female subjects with MDD with anxious distress using a population PK approach and explore its relationship with efficacy and safety parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be a man or woman between 18 and 64 years of age,
    2. Subjects must have a primary DSM-5 diagnosis of MDD with Anxious Distress. Subjects with a diagnosis of comorbid Generalized Anxiety Disorder (GAD), Social Anxiety Disorder, or Panic Disorder may be included, if the investigator considers MDD with Anxious Distress to be the primary diagnosis (confirmed by an independent central rater through review of the MINI interview obtained by the site at screening). Subjects must have been treated with an SSRI/SNRI antidepressant approved in this protocol at an adequate dose, as defined by the ATRQ, and for at least 6 continuous weeks, validated by an independent central rater contracted by the sponsor.
    3. A HDRS17 total score ≥ 18 at screening, assessed by a site rater and
    validated through review by an independent central rater contracted by the sponsor; and on Day 1 by site rater.
    4. A HDRS17 anxiety/somatization factor score ≥7at screening, assessed by a site rater and validated through review by an independent central rater contracted by the sponsor; and on Day 1 by site rater
    5. Before randomization, a woman must be either:
    • Not of childbearing potential: postmenopausal (>45 years of age with amenorrhea for at least 12 months, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level >40 IU/L); permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy
    • Of childbearing potential and practicing a highly effective method of
    birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies (i.e. one that results in a less than 1% per year failure rate when used
    consistently and correctly). This may include:
    o Established and ongoing use of oral hormonal methods of
    contraception in combination with barrier methods.
    o Established and ongoing use of patch, injected or implanted hormonal methods of contraception.
    o Placement of an IUD or IUS.
    Accepted barrier methods as indicated above include:
    - condom with spermicidal foam/gel/film/cream/suppository
    - occlusive cap (diaphragm or cervical/vault caps) with spermicidal
    Note that a barrier method on its own is not sufficient

    o Male partner sterilization (the vasectomized partner should be the sole partner for that subject).
    o True abstinence (when this is in line with the preferred and usual
    lifestyle of the subject).
    Women must agree to continue using these methods of contraception
    throughout the study and for at least 3 months after receiving the last
    dose of study medication.
    Note: If a woman of childbearing potential who is not heterosexually
    active becomes active after the start of the study, she must begin a
    highly effective method of birth control, as described above.
    • All women must have a negative pregnancy test at screening and a
    negative urine pregnancy test on study day 1.
    • All women must agree not to donate eggs (ova, oocytes) for the
    purposes of assisted reproduction during the study and for at least 3
    months after receiving the last dose of study drug.
    6. Men who are sexually active with a woman of childbearing potential and have not had a vasectomy must agree to use a barrier method of birth control e.g., either condom or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal
    foam/gel/film/cream/suppository for the duration of the study plus 3
    months after receiving the last dose of study drug, and all men must not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, their female partners should also use an additional method of birth control (which may include a hormonal method, an intrauterine device [IUD] or an intrauterine system [IUS]) for at least the same duration.
    E.4Principal exclusion criteria
    Any potential subject who meets any of the following criteria will be
    excluded from participating in the study unless otherwise specified:
    1. Has any other current major psychiatric condition, including, but not limited to, MDD with psychotic features (lifetime), bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, posttraumatic stress disorder, borderline personality disorder, eating
    disorder (e.g., bulimia, anorexia nervosa), or schizophrenia.
    The MINI will be conducted by the primary investigator/sub-investigator (either a psychiatrist or Ph.D. psychologist) at Screening to confirm MDD as the primary diagnosis. In addition, an independent rater will confirm that the current depressive episode is valid as well as verifying any comorbid psychiatric conditions validated in
    the MINI. As noted, subjects with a diagnosis of comorbid GAD, Social
    Anxiety Disorder, or Panic Disorder may be included.
    2. Has a length of current major depressive episode (MDE) >6 months.
    3. Has initiated psychotherapy specific for MDD (such as cognitive
    behavioral, behavioral, or interpersonal therapy) for the current episode of depression within 6 weeks prior to screening. Subjects receiving psychotherapy can continue receiving psychotherapy provided this therapy has been stable in frequency for the last 6
    months and will remain unchanged throughout the study treatment.
    4. Has more than 1 failed treatment with antidepressants of adequate
    dose and duration in the current major depressive episode, prior to and not including the inadequate response to the current SSRI/SNRI
    5. Has a history of resistance to medication treatment of major
    depressive episodes (≥3 lifetime treatment failures with approved
    antidepressants at adequate doses and duration).
    6. Has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 4 (active suicidal ideation with some intent to act, without specific plan) or 5 (active suicidal ideation with specific plan and intent) for ideation on the Columbia Suicide Severity Rating Scale (C-SSRS), or
    a history of suicidal behavior within the past year, as validated by the CSSRS at screening or Day 1. Subjects with a prior suicide attempt, or
    prior serious suicidal ideation/plan ≥ 6 months ago, should be carefully screened for current suicidal ideation and only included at the discretion of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to Endpoint on the Hamilton Depression Rating Scale (HDRS17) Total Score
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Week 6
    E.5.2Secondary end point(s)
    1) Change from Baseline to Endpoint on the Hamilton Anxiety Rating scale (HAM-A6) Score
    2) Change from Baseline to Endpoint on the SIGH-A (Structured Interview Guide of the Hamilton Anxiety Scale 14-item HAM-A) Total Score
    3) Change from Baseline to Endpoint on the Hamilton Anxiety Rating scale (HAM-D6) Score
    4) Change from Baseline to Endpoint in the Hamilton Depression Rating Scale (HDRS17) Anxiety/Somatization Factor Total Score
    5) Number of Participants with a Hamilton Depression Rating Scale (HDRS17) Anxiety/Somatization Factor Score Greater than or equal to 7 at Week 6
    6) Maximum Plasma Concentration (Cmax) of JNJ-42165279
    7) Time to Reach the Maximum Plasma Concentration (Tmax) of JNJ-42165279
    8) Area Under the Plasma Concentration-time Curve From Time Zero to Dosing Interval [AUC(0-t)]
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Baseline and Week 6
    2) Baseline and Week 6
    3) Baseline and Week 6
    4) Baseline and Week 6
    5) Week 6
    6) Pre-dose and 2 to 4 hours post-dose on Day 14, 35, 63 and 77
    7) Pre-dose and 2 to 4 hours post-dose on Day 14, 35, 63 and 77
    8) Pre-dose and 2 to 4 hours post-dose on Day 14, 35, 63 and 77
    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. 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 Yes
    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 trial4
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    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: 143
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 143
    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 Decision2017-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-04
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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