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    Summary
    EudraCT Number:2017-004829-33
    Sponsor's Protocol Code Number:17797A
    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:2018-07-30
    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 number2017-004829-33
    A.3Full title of the trial
    Interventional, open-label, flexible-dose study of vortioxetine on emotional functioning in patients with major depressive disorder with inadequate response to SSRI/SNRI treatment
    Estudio abierto, intervencionista y de dosis flexible de vortioxetina sobre la función emocional de los pacientes con trastorno depresivo mayor y respuesta inadecuada al tratamiento con ISRS/IRSN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study With Vortioxetine on Emotional Functioning in Patients With Depression
    Estudio con vortioxetina sobre la función emocional de los pacientes con Depresión
    A.4.1Sponsor's protocol code number17797A
    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 SponsorH. Lundbeck A/S
    B.1.3.4CountryDenmark
    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 supportH. Lundbeck A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationH. Lundbeck A/S
    B.5.2Functional name of contact pointLundbeckClinicalTrials@lundbeck.com
    B.5.3 Address:
    B.5.3.1Street AddressOttiliavej 9
    B.5.3.2Town/ cityValby
    B.5.3.3Post code2500
    B.5.3.4CountryDenmark
    B.5.4Telephone number004536301311
    B.5.5Fax number004536301940
    B.5.6E-mailLundbeckClinicalTrials@lundbeck.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 Brintellix 10 mg Film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderH. Lundbeck A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBrintellix
    D.3.4Pharmaceutical form Film-coated 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 INNvortioxetine
    D.3.9.1CAS number 508233-74-7
    D.3.9.3Other descriptive nameAA21004
    D.3.9.4EV Substance CodeSUB129930
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Brintellix 20 mg Film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderH. Lundbeck A/S
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameBrintellix
    D.3.4Pharmaceutical form Film-coated 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 INNvortioxetine
    D.3.9.1CAS number 508233-74-7
    D.3.9.3Other descriptive nameAA21004
    D.3.9.4EV Substance CodeSUB129930
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Emotional functioning in patients with MDD
    Función emocional en pacientes con trastorno depresivo mayor
    E.1.1.1Medical condition in easily understood language
    Many patients with MDD experience a restriction in the range of their emotions where they cannot feel either happy or sad. A numbness of feelings.
    Muchos pacientes con TDM experimentan una restricción en la gama de sus emociones y no pueden sentirse felices o tristes. Una sensación de entumecimiento de las emociones
    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 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 study will evaluate effectiveness of flexible dose vortioxetine 10-20 mg/day
    on emotional functioning in patients with MDD with an inadequate response to
    SSRIs/SNRIs.
    El estudio evaluará la efectividad de una dosis flexible de 10 o 20 mg de vortioxetina al día con respecto a la funcionalidad emocional en pacientes con un trastorno depresivo mayor (TDM) y una respuesta inadecuada al tratamiento con inhibidores selectivos de la recaptación de serotonina o con inhibidores de la recaptación de serotonina y noradrenalina (ISRS/IRSN)
    E.2.2Secondary objectives of the trial
    NA
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patient has a primary diagnosis of single or recurrent MDD according
    to DSM-5®. The current major depressive episode (MDE) must be
    confirmed using the Mini International Neuropsychiatric Interview (MINI).
    • The patient has had the current MDE for <12 months.
    • The patient has a Montgomery and Åsberg Depression Rating Scale
    (MADRS) total score ≥ 22 and ≤ 28 at the Baseline Visit.
    • The patient has been treated with SSRI/SNRI monotherapy (citalopram,
    escitalopram, paroxetine, duloxetine or venlafaxine) for at least 6 weeks at
    adequate dose for the current MDE and with an inadequate response and
    is a candidate for a switch in the investigator’s opinion.
    • The patient wants to switch antidepressant treatment.
    • The patient has an ODQ total score ≥50 at baseline, while on SSRI/SNRI
    monotherapy (prior to switch).
    • The patient answered “Yes “to the screening question on emotional effects.
    • El paciente tiene un diagnóstico principal de TDM único o recidivante según el DSM-5®. El episodio depresivo mayor (EDM) actual debe confirmarse utilizando la Minientrevista neuropsiquiátrica internacional, MINI (Mini International Neuropsychiatric Interview).
    • El paciente ha presentado el EDM actual durante < 12 meses.
    • En la visita inicial, el paciente ha obtenido una puntuación total ≥ 22 y ≤ 28 en la escala de clasificación de la depresión de Montgomery y Åsberg, MADRS (Montgomery and Åsberg Depression Rating Scale).
    • El paciente ha recibido tratamiento con ISRS/IRSN en monoterapia (citalopram, escitalopram, paroxetina, duloxetina o venlafaxina) durante un mínimo de 6 semanas con una dosis adecuada para el EDM actual y ha obtenido una respuesta inadecuada, además de ser candidato para cambiar de medicación, a juicio del investigador.
    • El paciente desea cambiar de tratamiento antidepresivo.
    • En la visita inicial, el paciente tiene una puntuación total ≥ 50 en el Cuestionario de depresión de Oxford, ODQ (Oxford Depression Questionnaire), durante la monoterapia con ISRS/IRSN (antes de cambiar de tratamiento).
    • El paciente respondió afirmativamente a la pregunta de selección sobre efectos emocionales.
    E.4Principal exclusion criteria
    The patient has a significant risk of suicide according to the investigator’s
    clinical judgment or has made an actual suicide attempt in the previous 6
    months prior to Baseline
    El paciente tiene un riesgo significativo de suicidio de acuerdo con el criterio clínico del investigador o ha realizado un intento de suicidio real en los 6 meses anteriores al inicio.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline to Week 8 in Oxford Depression Questionnaire (ODQ) total score
    Cambio desde el inicio del estudio hasta la semana 8 en la puntuación total obtenida en el Cuestionario de depresión de Oxford (ODQ)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 8
    Desde el inicio hasta la semana 8
    E.5.2Secondary end point(s)
    Change from baseline to Week 8 in MEI total score
    Change from baseline to Week 8 in DSST total score
    Change from baseline to Week 8 in ODQ domain scores (NC, ED, PR, GR, and AC)
    Change from baseline to Week 8 in MADRS total score
    Change from baseline to Week 8 in SDS individual item scores (family, work, and social life)
    Change from baseline to Week 8 in SDS total scores
    Change from baseline to Week 8 in CGI-S score
    CGI-I score at Week 8
    Cambio desde el inicio del estudio hasta la semana 8 en la puntuación total obtenida en el MEI
    Cambio desde el inicio del estudio hasta la semana 8 en la puntuación total obtenida en el DSST
    Cambio desde el inicio del estudio hasta la semana 8 en las puntuaciones obtenidas en el ODQ en cada dominio (NC, ED, PR, GR y AC)
    Cambio desde el inicio del estudio hasta la semana 8 en la puntuación total obtenida en MADRS
    Cambio desde el inicio del estudio hasta la semana 8 en las puntuaciones individuales obtenidas en el SDS (vida familiar, laboral y social)
    Cambio desde el inicio del estudio hasta la semana 8 en las puntuaciones totales obtenidas en el SDS
    Cambio desde el inicio del estudio hasta la semana 8 en la puntuación obtenida en el CGI-S
    Puntuación obtenida en el CGI-I en la semana 8
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to Week 8
    Desde el inicio hasta la semana 8
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 150
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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
    Ninguno
    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 Decision2018-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-02-21
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