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    Summary
    EudraCT Number:2019-001326-10
    Sponsor's Protocol Code Number:18315A
    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:2019-12-02
    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 number2019-001326-10
    A.3Full title of the trial
    Interventional, open-label study of flexible doses of vortioxetine on depressive symptoms in patients with major depressive disorder and early dementia
    Estudio intervencionista sin enmascaramiento para la evaluación de dosis flexibles de vortioxetina en los síntomas depresivos de pacientes con trastorno depresivo mayor y demencia precoz
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vortioxetine in Patients With Depression and Early Dementia
    Vortioxetina en pacientes con depresión y demencia precoz
    A.4.1Sponsor's protocol code number18315A
    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 5 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.3.4Pharmaceutical 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.3.9.4EV Substance CodeSUB88928
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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.3.4Pharmaceutical 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.3.9.4EV Substance CodeSUB88928
    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: 3
    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.3.4Pharmaceutical 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.3.9.4EV Substance CodeSUB88928
    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
    Depressive symptoms in patients with major depressive disorder (MDD) and early dementia
    Síntomas de depresión en pacientes con trastorno depresivo mayor (TDM) y demencia precoz
    E.1.1.1Medical condition in easily understood language
    Depression and dementia
    Depresión y demencia
    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 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
    To assess the effectiveness of 12-week acute treatment with flexible dose 5-20 mg/day vortioxetine on depressive symptoms in patients with major depressive disorder (MDD) and early dementia
    Evaluar la eficacia de un tratamiento breve de 12 semanas de duración con dosis flexibles de entre 5 y 20 mg/día de vortioxetina en los síntomas depresivos de pacientes con trastorno depresivo mayor (TDM) y demencia precoz
    E.2.2Secondary objectives of the trial
    To assess the effectiveness of 12-week acute treatment with 5-20 mg/day vortioxetine on:
    • cognitive function
    • functioning
    • global clinical impression
    • depression
    • health-related quality of life
    Evaluar la eficacia de un tratamiento breve de 12 semanas de duración con dosis de entre 5 y 20 mg/día de vortioxetina en los aspectos siguientes:
    - funcionamiento cognitivo
    - capacidad funcional
    - impresión clínica global
    - depresión
    - calidad de vida relacionada con la salud
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The patient has a primary diagnosis of recurrent Major Depressive Disorder (MDD) with onset before age of 55, diagnosed 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 <6 months.
    • The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Baseline Visit.
    • The diagnosis of onset of dementia has occurred at least 6 months prior to screening and after already being diagnosed with MDD. The diagnosis of dementia must be documented in patient’s medical records. When deemed necessary per investigator judgement of patient clinical status and early dementia, the patient must be accompanied by a caregiver to study visits.
    • Patients with dementia associated with vitamin B12 or folate deficiency should not be enrolled.
    • Patients with or without treatment for dementia can be enrolled. For patients on treatment for dementia, there must be no change in treatment during the study and patients must be on stable dose for at least 3 months prior to the Screening Visit.
    • The patient has Mini Mental State Examination (MMSE) total score 20-24, inclusive.
    • El paciente tiene un diagnóstico principal de trastorno depresivo mayor (TDM) recurrente aparecido antes de los 55 años de edad. El diagnóstico debe haberse realizado con arreglo al DSM 5®.
    • El episodio depresivo mayor (EDM) actual debe confirmarse mediante la Minientrevista neuropsiquiátrica internacional (MINI).
    • El paciente lleva sufriendo el EDM actual <6 meses.
    • El paciente tiene una puntuación total ≥26 en la Escala de clasificación de la depresión de Montgomery y Asberg (MADRS) en la visita basal.
    • El diagnóstico del inicio de la demencia se ha producido al menos 6 meses antes de la selección y después de haber recibido ya el diagnóstico de TDM. El diagnóstico de demencia debe figurar en la historia clínica del paciente. El paciente debe acudir a las visitas del estudio acompañado de un cuidador cuando el investigador lo considere necesario teniendo en cuenta su estado clínico y lo avanzado de la demencia precoz.
    • No debe incluirse a pacientes con demencia asociada a la carencia de vitamina B12 o folato.
    • Puede incluirse a pacientes con o sin tratamiento para la demencia. En el caso de los pacientes en tratamiento para la demencia, no debe realizarse ningún cambio en el tratamiento durante el estudio, y la dosis debe haber permanecido estable durante, como mínimo, los 3 meses anteriores a la visita de selección.
    • El paciente tiene una puntuación total de entre 20 y 24 (ambas incluidas) en el Miniexamen del estado mental (MMSE).
    E.4Principal exclusion criteria
    • The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria), established as the primary diagnosis, other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview.
    • El paciente padece algún trastorno psiquiátrico actualmente o trastorno de Eje I (criterios DSM-5®), establecido como diagnóstico principal y diferente al TDM, según evaluación mediante la Entrevista neuropsiquiátrica internacional breve (MINI) u otra entrevista de diagnóstico.
    E.5 End points
    E.5.1Primary end point(s)
    Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
    Cambio en la puntuación total de la Escala de clasificación de la depresión de Montgomery y Asberg (MADRS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to Week 12
    Desde el inicio hasta la semana 12
    E.5.2Secondary end point(s)
    • Change in Digit-Symbol Substitution Test (DSST) Substitution Test (DSST) score*
    • Change in Rey Auditory Verbal Learning Test (RAVLT) score*
    • Change in Instrumental Activities of Daily Living (IADL) score*
    • Change in Clinical Global Impression - Severity (CGI-S) score*
    • Clinical Global Impression - Improvement (CGI-I) score**
    • Response (defined as a 50% decrease from baseline in MADRS total score)**
    • Remission (MADRS ≤10)**
    • Change in Bath Assessment of Subjective Quality of Life in Dementia (BASQID) score*
    • Cambio en la puntuación de la prueba de sustitución de dígitos y símbolos (DSST)*
    • Cambio en la puntuación de la prueba de aprendizaje auditivo verbal de Rey (RAVLT)*
    • Cambio en la puntuación de las Actividades instrumentales de la vida diaria (IADL)*
    • Cambio en la puntuación de la Impresión clínica global sobre la gravedad (CGI-S)*
    • Puntuación de la Impresión clínica global sobre la mejoría (CGI-I)**
    • Respuesta (definida como una reducción del 50 % en la puntuación total de la MADRS respecto al valor inicial)**
    • Remisión (MADRS ≤10)**
    • Cambio en la puntuación de la Evaluación de Bath sobre la calidad de vida subjetiva en la demencia (BASQID)*
    E.5.2.1Timepoint(s) of evaluation of this end point
    * From baseline to Week 12
    ** At Week 12
    * Desde el inicio hasta la semana 12
    ** En la semana 12
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    Estonia
    Finland
    France
    Italy
    Korea, Republic of
    Spain
    Switzerland
    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
    The overall end of the study is defined as the last protocol-specified contact with the last patient ongoing in the study. The last protocol-specified contact is a safety follow-up. This may be a telephone contact, unless an SAE has occurred since the previous visit. The safety follow-up must be conducted 4 weeks after the last dose of IMP.
    El fin del estudio general se define como el último contacto especificado en el protocolo con el último paciente que participe en el estudio. El último contacto especificado en el protocolo es un seguimiento de seguridad y puede ser un contacto telefónico, a menos que haya habido algún AAG desde la visita anterior. El seguimiento de seguridad debe realizarse 4 semanas después de la última dosis de PEI.
    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 months9
    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 months9
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 72
    F.4.2.2In the whole clinical trial 100
    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 Decision2019-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
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