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    Summary
    EudraCT Number:2015-002007-29
    Sponsor's Protocol Code Number:42165279MDD2001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-10-05
    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 ConcernedSpain - AEMPS
    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
    Ensayo fase 2a multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para estudiar la eficacia, la seguridad y la tolerabilidad de JNJ-42165279 en pacientes con trastorno de depresión mayor con ansiedad.
    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
    Estudio de eficacia, seguridad y tolerabilidad de JNJ-42165279 en pacientes con trastorno de depresión mayor con ansiedad.
    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.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 & 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.5.3.4CountryNetherlands
    B.5.4Telephone number+3171524 21 66
    B.5.5Fax number+3171524 21 10
    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 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.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
    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
    Anxiety
    Trastorno depresión mayor
    Ansiedad
    E.1.1.1Medical condition in easily understood language
    Major Depressive Disorder
    Anxiety
    Trastorno depresión mayor
    Ansiedad
    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 18.0
    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 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).
    El objetivo principal de este estudio es evaluar la eficacia en términos de reducción de los síntomas de depresión y ansiedad evaluados mediante el cambio con respecto a los valores basales en la escala de 17 puntos de Clasificación de la Depresión de Hamilton (HDRS17), y la seguridad y la tolerabilidad globales del tratamiento con JNJ-42165279 adyuvante frente al placebo en sujetos con trastorno de depresión mayor (TDM) con síntomas de ansiedad y una respuesta inadecuada al tratamiento con un inhibidor selectivo de la recaptación de serotonina (ISRS) o un inhibidor de la recaptación de serotonina/norepinefrina (IRSN).
    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.
    ? evaluar la eficacia de JNJ-42165279 sobre los síntomas principales de ansiedad (HAM-A6).
    ? evaluar la eficacia de JNJ-42165279 a través de análisis dimensionales de la ansiedad y la depresión (HDRS17 y SIGH-A).
    ? evaluar la eficacia de JNJ-42165279 sobre la respuesta y la remisión de los síntomas de depresión y ansiedad (derivada de HDRS17 y SIGH-A).
    ? evaluar el perfil farmacocinético (FC) en plasma de JNJ-42165279 administrado siguiendo una pauta de una vez al día c/d) en pacientes de ambos sexos con TDM y ansiedad usando FC poblacional y explorar su relación con los parámetros de eficacia y seguridad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant must meet the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or 5 diagnostic criteria for
    major depressive disorder (MDD) with Anxious Distress
    - Participants with a diagnosis of comorbid Generalized Anxiety Disorder, 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 at screening)
    - Participants must have been treated with an approved SSRI/SNRI antidepressant for at least 6 continuous weeks, validated by and independant central rater contracted by the sponsor
    - A 17-item Hamilton Depression Rating Scale (HDRS17) total score greater than or equal to (>=)18 and a HDRS17 anxiety/somatization factor score >=7 at screening, assessed by a site rater and reviewed by an independent central rater on Day 1
    - Participant must be willing and able to adhere to the prohibitions and restrictions
    - Participant Body mass index (BMI= weight/height2) must be between 18 and 35 kilogram per square meter (kg/m2)
    - Los pacientes deben tener un diagnóstico primario según el DSM-5 de TDM con ansiedad.
    - Los pacientes con un diagnóstico de trastorno de ansiedad generalizado (TAG), trastorno de ansiedad social o trastorno de pánico se pueden incluir si el investigador considera que el TDM con ansiedad es el diagnóstico principal (confirmado por un evaluador central independiente tras revisar la entrevista del MINI obtenida por el centro en la selección).
    - Los pacientes tienen que haber sido tratados con un antidepresivo ISRS/IRSN autorizado durante al menos 6 semanas seguidas, verificado por un evaluador central independiente designado por el promotor.
    - Una puntuación total en la escala HDRS17 de ? 18 en la selección, realizada por un evaluador del centro y revisada por un evaluador central independiente designado por el promotor y en el día 1 por un evaluador del centro.
    - El paciente debe estar dispuesto y ser capaz de cumplir las prohibiciones y restricciones que se especifican en este protocolo
    - Los pacientes deben tener un índice de masa corporal (IMC= peso/altura²) entre 18 y 35 kg/m2, ambos valores incluidos, en la selección.
    E.4Principal exclusion criteria
    - Has other psychiatric condition, including, but not limited to, MDD with psychotic features, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, borderline personality disorder, eating disorder, or schizophrenia
    - Has a length of current Major Depressive Episode (MDE) greater than (>) 6 months
    - Has more than 1 failed antidepressant treatment of adequate dose and duration in the current MDE, Not including the inadequate response to the current selective serotonin reuptake inhibitor (SSRI) or serotonergic/noradrenergic reuptake inhibitor (SNRI) antidepressant
    - 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
    - Has a current or recent history of clinically significant suicidal ideation
    within the past 6 months, or a history of suicidal behavior within the past year
    - Sufren cualquier otra afección psiquiátrica mayor actual por ejemplo, sin limitaciones, TDM con rasgos psicóticos (durante toda la vida), trastorno bipolar (incluido el diagnóstico de por vida), trastorno obsesivo-compulsivo, trastorno por estrés postraumático, trastorno de la personalidad límite, trastorno de alimentación (por ejemplo, bulimia, anorexia nerviosa) o esquizofrenia.
    - El episodio depresivo mayor actual (EDM) dura >6 meses
    - Ha sufrido fracaso de más de 1 tratamiento con antidepresivos a la dosis y duración adecuadas en el actual episodio depresivo mayor, antes de y sin incluir la respuesta inadecuada al actual antidepresivo IRSS/IRSN.
    - Ha iniciado psicoterapia específica para el TDM (como terapia conductual cognitiva, conductual o interpersonal) para el episodio depresivo actual en las 6 semanas anteriores a la selección.
    - Tiene historial actual o reciente de ideación suicida clínicamente significativa en los últimos seis meses, o historial de comportamiento suicida en el último año
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to Endpoint on the Hamilton Depression Rating Scale (HDRS17) Total Score
    Cambio en la puntuación total en la escala HDRS17 del inicio al fin.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and Week 6
    Visita inicial y Semana 6
    E.5.2Secondary end point(s)
    El cambio con respecto a la situación basal de la puntuación en la escala 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)]
    1) El cambio con respecto a la situación basal de la puntuación en la escala HAM-A6.
    2) El cambio con respecto a la situación basal de la puntuación en la escala SIGH-A y HAM-A.
    3)El cambio con respecto a la situación basal de la puntuación en la escala HAM-D6)
    4)El cambio con respecto a la situación basal de la puntuación en la puntuación del factor de ansiedad/somatización en la HDRS17.
    5)Número de participantes con una puntuación del factor de ansiedad/somatización en la HDRS17 igual o superior a 7 en la semana 6.
    6)Máxima concentración plasmática del JNJ-42165279.
    7)TIempo hasta alcanzar la concentración máxima plasmática del JNJ-42165279.
    8) Área bajo la curva del tiempo de concentración plasmática desde cero hasta el intervalo de dosis [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
    1) Baseline and Week 6
    2) Visita inicial y semana 6
    3) Visita inicial y semana 6
    4) Visita inicial y semana 6
    5) Semana 6
    6) Pre-dosis y 2 a 4 horas post-dosis en los días 14, 35, 63 and 77
    7) Pre-dosis y 2 a 4 horas post-dosis en los días 14, 35, 63 and 77
    8) Pre-dosis y 2 a 4 horas post-dosis en los días 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.7.1.3.1Other 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Romania
    Russian Federation
    Spain
    Ukraine
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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: 140
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 140
    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)
    None
    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 Decision2015-11-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-04
    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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