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    Summary
    EudraCT Number:2012-002954-21
    Sponsor's Protocol Code Number:KETIVEDI2001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-11-12
    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 number2012-002954-21
    A.3Full title of the trial
    An exploratory, blinded, randomized, placebo-controlled study in subjects with depressive disorder to investigate the effect of minocycline on relapse after successful intravenous ketamine/minocycline-induced (partial) symptoms response
    Estudio exploratorio, ciego, aleatorizado, controlado con placebo en sujetos con trastorno depresivo para investigar el efecto de la minociclina en recaída tras respuesta (parcial) sintomática satisfactoria inducida por ketamina intravenosa / minociclina.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Effect of Minocycline on Relapse After Successful Intravenous Ketamine/Minocycline-induced Symptoms Response in Subjects with Depression
    El efecto de la minociclina en recaída tras respuesta (parcial) sintomática satisfactoria inducida por ketamina intravenosa / minociclina
    A.4.1Sponsor's protocol code numberKETIVEDI2001
    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 N.V.
    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
    B.4.2CountryBelgium
    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 Yes
    D.2.1.1.1Trade name Ketamine Panpharma
    D.2.1.1.2Name of the Marketing Authorisation holderPanpharma Laboratories
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameKetamine Panpharma - solution injectable - 50 mg/5 ml
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKETAMINE HYDROCHLORIDE
    D.3.9.3Other descriptive nameKETAMINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB02830MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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.2.1.1.1Trade name Minocin
    D.2.1.1.2Name of the Marketing Authorisation holderTeofarma Srl
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameMinocin - hard capsule - 100 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 INNMINOCYCLINE HYDROCHLORIDE
    D.3.9.1CAS number 13614-98-7
    D.3.9.3Other descriptive nameMINOCYCLINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB03304MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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
    Depressive Disorder
    Trastorno depresivo
    E.1.1.1Medical condition in easily understood language
    Depression
    Depresión
    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 16.1
    E.1.2Level PT
    E.1.2Classification code 10004940
    E.1.2Term Bipolar II disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    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 whether the antidepressant response to IV ketamine can be maintained by minocycline compared to placebo.
    El objetivo principal de este estudio es determinar si la respuesta antidepresiva a la ketamina intravenosa puede mantenerse por la acción de la minociclina en comparación con un placebo.
    E.2.2Secondary objectives of the trial
    To investigate the safety and tolerability of the administered study medications (i.e., ketamine and minocycline).

    To investigate the effect of minocycline on symptoms of depression in ketamine non-responders.
    Los objetivos secundarios de este estudio son:
    Investigar la seguridad y la tolerabilidad de los fármacos del estudio administrados (es decir, ketamina y minociclina).
    Investigar el efecto de la minociclina en los síntomas de depresión en pacientes que no responden a la ketamina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnostic criteria for moderate to severe major depressive disorder (MDD), without mood incongruent psychotic features, or Bipolar Disorder Type II
    - Patients should have an Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) total score ? 34 at Screening and at Day 1 (predose)
    - Patients with major depressive disorder should have failed at least two adequate treatment courses (dose and duration) with antidepressant therapy, one of which is in the current episode
    - Patients should not have received electroconvulsive therapy (ECT) in the current episode but could be those for whom ECT is considered
    - Patients with bipolar depression (BPD) Type II must have been taking a stable dose of a mood-stabilizing medication (e.g., lithium, valproate, carbamazepine, lamotrigine, antipsychotic agents) for at least 4 weeks, dosed clinically to target the therapeutic range
    - Patients currently taking an antidepressant(s) must have received at least 2 weeks of stable antidepressant therapy at the time of Screening
    - Doses of current antidepressant therapies should remain the same for the duration of the study
    - Women must be postmenopausal, surgically sterile, or if heterosexually active, practicing a highly effective method of birth control
    - Men who are heterosexually active with a woman of childbearing potential must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
    - Criterio diagnóstico de trastorno depresivo mayor (TDM) moderado o severo, sin síntomas psicóticos incongruentes del ánimo, o trastorno bipolar tipo II.
    - Los pacientes deben tener una puntuación total ≥ 34 en el Cuestionario de síntomas depresivos valorados por el médico (IDS-C30) en la visita de selección y el día 1 (antes de la administración).
    - Los pacientes con TDM deben no haber respondido al menos a dos ciclos de tratamiento adecuados (dosis y duración) con un antidepresivo, uno de los cuales corresponde al episodio actual.
    - No haber recibido TEC en el episodio actual, pero podría haberse considerado en ellos el uso del TEC.
    - Los pacientes con TBP de tipo II deben haber estado tomando una dosis estable de un medicamento estabilizador del estado de ánimo (p. ej., litio, ácido valproico, carbamazepina, lamotrigina, antipsicóticos) durante al menos 4 semanas, en dosis clínicas para alcanzar el intervalo terapéutico.
    - Los pacientes que estén recibiendo un antidepresivo deben haber recibido al menos 2 semanas de tratamiento antidepresivo estable en el momento de la selección
    -Las dosis del antidepresivo actual deben ser las mismas durante todo el estudio.
    - Las mujeres deben ser posmenopáusicas, estar esterilizadas quirúrgicamente, en caso de mantener relaciones heterosexuales, deben utilizar un método anticonceptivo eficaz.
    - Los hombres que mantengan relaciones heterosexuales con una mujer con capacidad reproductiva deberán comprometerse a utilizar un método anticonceptivo de doble barrera y a no donar semen durante el estudio y durante 3 meses después de recibir la última dosis del fármaco del estudio.

    E.4Principal exclusion criteria
    - Has a current DSM-IV axis I diagnosis other than MDD or BPD Type II at screening (except for co-morbid anxiety disorders)
    - Has a diagnosis of substance abuse or dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
    - Patient is currently taking ? 4 psychotropic medications at Day 1 (predose)
    - Has an autoimmune disorder such as Crohn?s disease, rheumatoid arthritis, psoriasis currently treated with/requiring treatment with immunomodulatory therapies
    -Has any significant cardiovascular, respiratory, neurologic, renal, hepatic, endocrine, immunologic diseases, glaucoma, hypothyroidism or hyperthyroidism based on screening examination
    - Has uncontrolled hypertension (diastolic blood pressure ? 90 mmHg), despite diet, exercise or a stable dose of an allowed antihypertensive treatment, at Screening or Day 1 (predose)
    - Has planned vaccination within 2 weeks prior to the first dose of study medication through 2 weeks after the last dose of study medication
    - Has an active infectious disease/current infection
    - Has known allergies, hypersensitivity, or intolerance to minocycline or ketamine or its excipients
    - Has contraindications to the use of minocycline or ketamine per local prescribing information
    -Tiene actualmente un diagnóstico del eje I del DSM-IV distinto de TDM o TBP tipo II (excepto trastornos de ansiedad comórbidos) en la visita de selección.
    -Tiene antecedentes de abuso o dependencia del alcohol o de sustancias conforme a los criterios del Manual diagnóstico y estadístico de los trastornos mentales (4.a edición) (DSM-IV), excepto nicotina y cafeína, en los 6 meses previos a la visita de selección.
    -Está tomando ≥ 4 psicofármacos el día 1 (antes de la administración).
    -Tiene un trastorno autoinmunitario tal como la enfermedad de Crohn, artritis reumatoide o psoriasis tratado actualmente con inmunomoduladores o que requiere inmunomoduladores.
    -Tiene una enfermedad cardiovascular, respiratoria, neurológica, renal, hepática, endocrina, inmunológica importante, glaucoma, hipotiroidismo o hipertiroidismo conforme a la exploración de selección.
    -Padece hipertensión no controlada (presión arterial diastólica ≥ 90 mm Hg), a pesar de controlar la dieta, hacer ejercicio o tomar una dosis estable de un antihipertensivo permitido, en la visita de selección o el día 1 (antes de la administración).
    -Tiene previsto vacunarse desde 2 semanas antes de la primera dosis de la medicación del estudio hasta 2 semanas después de la última dosis de la medicación del estudio.
    -Tiene una enfermedad infecciosa activa/infección actual.
    -Padece alergias, hipersensibilidad o intolerancia conocidas a la minociclina, a la ketamina o a sus excipientes.
    -Tiene contraindicaciones para el uso de minociclina o ketamina conforme a la ficha técnica local.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint will be the proportion of subjects who survive relapse-free (among responders).
    El criterio de valoración principal de la eficacia será la proporción de pacientes que sobrevivan sin recaídas (entre los pacientes con respuesta)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 54 (Week 6) of the 6-week blinded treatment period.
    Dia 54 (Semana 6) de las 6 semanas de tratamiento ciego
    E.5.2Secondary end point(s)
    1. The change in MADRS total score among non-responders from pre-randomization to end-of-study.
    2. Change in the MADRS total score from baseline during the IV ketamine treatment phase.
    3. Change in the MADRS total score from baseline after IV ketamine treatment phase.
    4. Response (reduction ? 50% in MADRS total score relative to baseline) rate during the IV ketamine treatment phase.
    5. Time to relapse (among responders) following completion of the IV ketamine infusion schedule .
    6. Change in Columbia Suicide Severity Rating Scale (C-SSRS).
    1 Cambio de la puntuación total de la escala MADRS entre los pacientes que no respondan desde pre-aleatorización hasta el final del estudio.
    2 Cambio de la puntuación total de la escala MADRS con respecto al valor basal (día 1 antes de la administración) durante la fase de tratamiento con ketamina intravenosa.
    3 Cambio de la puntuación total de la escala MADRS con respecto al valor basal (día 1 antes de la administración) después de la fase de tratamiento con ketamina intravenosa.
    4 Tasa de respuesta (reducción ≥ 50% de la puntuación total de la escala MADRS con respecto al valor basal) durante la fase de tratamiento con ketamina intravenosa.
    5 Tiempo hasta la recaída (entre los pacientes con respuesta) después de la finalización de la pauta de infusión de ketamina intravenosa.
    6 Efectos sobre la escala de valoración de la gravedad de la conducta suicida de Columbia (C-SSRS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. From Day 12 to Day 54.
    2. Days 1, 3, 5, 8, 10, and 12.
    3. Days 1, 20, 27, 34, 41, 48, and 54.
    3. Days 1, 3, 5, 8, 10 and 12.
    4. Day 12 to Day 54.
    5. Day 1, 12 & 54.
    1. Desde día 12 a día 54
    2. Días 1, 3, 5, 8, 10, y 12.
    3. Días 1, 20, 27, 34, 41, 48, y 54.
    3. Días 1, 3, 5, 8, 10 y 12.
    4. Día 12 a día 54.
    5. Día 1, 12 y 54.
    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 Yes
    E.6.13.1Other scope of the trial description
    Biomarker Marker Analysis
    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 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 trial3
    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 EEA15
    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
    Belgium
    France
    Moldova, Republic of
    Netherlands
    Spain
    Romania
    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
    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 months2
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days25
    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: 64
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    All subjects can return to standard of care treatment following the End-of-Study (EOS) visit.
    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 Decision2014-01-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-07-10
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