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    Summary
    EudraCT Number:2019-004548-31
    Sponsor's Protocol Code Number:HUB-PSI-CAMAD
    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:2020-01-14
    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 number2019-004548-31
    A.3Full title of the trial
    A RANDOMIZED, CONTROLLED, OPEN AND UNICENTRIC PHASE II CLINICAL TRIAL, WITH TWO PARALLEL GROUPS, TO EVALUATE THE ANTIDEPRESSANT EFFICACY OF PSYCHOTHERAPY AND CITALOPRAM IN WOMEN DIAGNOSED WITH BREAST CANCER AND MAJOR DEPRESSION. CAMAD PROJECT
    ENSAYO CLÍNICO DE FASE II, ALEATORIZADO, CONTROLADO, ABIERTO Y UNICÉNTRICO, CON DOS GRUPOS PARALELOS, PARA EVALUAR LA EFICACIA ANTIDEPRESIVA DE LA PSICOTERAPIA Y DEL CITALOPRAM EN MUJERES DIAGNOSTICADAS DE CÁNCER DE MAMA Y DEPRESIÓN MAYOR. PROYECTO CAMAD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL TO EVALUATE THE ANTIDEPRESSANT EFFICACY OF PSYCHOTHERAPY AND CITALOPRAM IN WOMEN DIAGNOSED WITH BREAST CANCER AND MAJOR DEPRESSION
    ENSAYO CLÍNICO PARA EVALUAR LA EFICACIA ANTIDEPRESIVA DE LA PSICOTERAPIA Y DEL CITALOPRAM EN MUJERES DIAGNOSTICADAS DE CÁNCER DE MAMA Y DEPRESIÓN MAYOR
    A.4.1Sponsor's protocol code numberHUB-PSI-CAMAD
    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 SponsorCinto Segalàs
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAsociación Española Contra El Cáncer
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCinto Segalàs
    B.5.2Functional name of contact pointCinto Segalàs
    B.5.3 Address:
    B.5.3.1Street AddressFeixa Llarga s/n
    B.5.3.2Town/ cityL'Hopitalet de Llobregat
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number0034932607922
    B.5.5Fax number0034932607658
    B.5.6E-mailcsegalas@bellvitgehospital.cat
    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 PRISDAL 20mg PRISDAL 30mg
    D.2.1.1.2Name of the Marketing Authorisation holderLundbeck España, SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCitalopram
    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 INNCITALOPRAM
    D.3.9.1CAS number 59729-33-8
    D.3.9.4EV Substance CodeSUB07485MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 40
    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
    Female patients diagnosed with breast cancer who, during the first year following the diagnosis of oncological disease, have affective symptomatology that meets DSM-V criteria for major depression.
    Pacientes mujeres diagnosticadas de cáncer de mama que a lo largo del primer año tras el diagnóstico de la enfermedad oncológica presentan sintomatología afectiva que cumple criterios DSM-V de depresión mayor.
    E.1.1.1Medical condition in easily understood language
    Breast cancer and major depression disease.
    Cáncer de mama y depresión mayor.
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10057654
    E.1.2Term Breast cancer female
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy:
    -To provide evidence on the antidepressant efficacy of two therapeutic treatments: pharmacological treatment (citalopram) and psychotherapy treatment, in women diagnosed with breast cancer and major depression.
    Eficacia:
    -Aportar evidencia sobre la eficacia antidepresiva de dos estrategias terapéuticas: tratamiento farmacológico (citalopram) y tratamiento con psicoterapia, en mujeres diagnosticadas de CM y DM.
    E.2.2Secondary objectives of the trial
    Efficacy:
    -To evaluate the antidepressant effect of the therapeutic treatment studied and Quality life impact.
    -To evaluate the antidepressant effect of the therapeutic treatments studied and their socio-labour adaptation impact.
    -To estimate which clinical, sociodemographic and onco-specific treatment variables predict a greater antidepressant response to a specific treatment strategy.
    Biomarkers:
    -To study possible functional neuroimaging and emotional processing biomarkers, specific of major depression in breast cancer that could predict the response to a specific therapeutic treatment
    Safety:
    -Assess the safety (12 weeks) of the two therapeutic treatments studied: pharmacological treatment (citalopram) and psychotherapy treatment.
    Objectives pharmaco-economics
    -To estimate the cost-effectiveness ratio of pharmacological treatment with citalopram regarding psychological treatmen with breast cancer and major depression, as well as its economic impact on back to work.
    Eficacia:
    -Evaluar el efecto antidepresivo de las estrategias terapéuticas estudiadas y su impacto en la calidad de vida.
    -Evaluar el efecto antidepresivo de las estrategias terapéuticas estudiadas y su impacto en la adaptación socio-laboral.
    -Estimar qué variables clínicas, sociodemográficas y de tratamiento oncoespecífico predicen una mayor respuesta antidepresiva a una estrategia de tratamiento concreta.
    Biomarcadores:
    -Estudiar posibles biomarcadores de neuroimagen funcional y procesamiento emocional específicos de la DM en el CM y que permitan predecir la respuesta a una estrategia terapéutica determinada.
    Seguridad:
    -Evaluar la seguridad (12 semanas) de las dos estrategias terapéuticas estudiadas: tratamiento farmacológico (citalopram) y tratamiento con psicoterapia.
    Objetivos fármaco-economía
    -Relación coste-efectividad del tratamiento farmacológico con citalopram respecto al tratamiento psicológico, así como su impacto económico en la reincorporación laboral.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Female patients first time diagnosed with breast cancer (stage I, II, III, or IV) between ages 18 and 75 (both inclusive)
    - Patients with a "moderate-severe" level of emotional distress who meet the diagnostic criteria of major depression for at least two weeks or adaptive disorder with depressive mood for at least two months, according to DSM-V criteria, during the twelve months following the diagnose of breast cancer.
    - Minimum score of 14 on the Hamilton Depression Scale (HDRS)
    - Informed Consent Form Signature
    • Pacientes mujeres diagnosticadas de novo de CM (estadio I, II, III o IV) entre 18 y 75 años (ambos inclusive)
    • Pacientes que presenten nivel de malestar emocional “moderado-severo” y cumplan criterios diagnósticos de depresión mayor durante como mínimo dos semanas o de trastorno adaptativo con ánimo depresivo durante un mínimo de dos meses, según criterios DSM-V, durante los doce meses tras el diagnóstico de CM
    • Puntuación mínima de 14 en la escala Hamilton de depresión (HDRS)
    • Firma del consentimiento informado
    E.4Principal exclusion criteria
    • Women who are pregnant or breastfeeding.
    • Suicide risk.
    • Brain metastatic disease.
    • Personal history of oncological disease.
    • Personal History of serious somatic disease (cardiac, hepatic, respiratory, endocrinological, neurological and haematological).
    • Personal History of organic brain disorder, substance abuse/dependence.
    • Personal History of psychotic disorder, bipolar disorder and/or mental retardation.
    • Contraindications of citalopram treatment
    • Taking antidepressants after the breast cancer diagnosis.
    • psychotherapy treatment after breast cancer diagnosis .
    • Mujeres embarazadas o que realicen lactancia.
    • Riesgo suicida.
    • Enfermedad metastásica cerebral.
    • Antecedentes personales de enfermedad oncológica.
    • Historia de enfermedad somática grave (cardíaca, hepática, respiratoria, endocrinológica, neurológica y hematológica).
    • Historia de trastorno orgánico cerebral, abuso/dependencia de sustancias.
    • Antecedentes de trastorno psicótico, trastorno bipolar y/o retraso mental.
    • Contra-indicaciones para recibir tratamiento con citalopram.
    • Toma de antidepresivos después del diagnóstico del CM.
    • Realización de psicoterapia después del diagnóstico del CM.
    E.5 End points
    E.5.1Primary end point(s)
    -Antidepressant efficacy: Score on the HDRS scale.
    - Eficacia antidepresiva: Puntuación en la escala HDRS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The assessment of the main end point is in visit end of cure.
    La valoración de la variable principal es en la visita fin de tratamiento.
    E.5.2Secondary end point(s)
    Antidepressant efficacy: Quality of life questionnaire score EQ-5D-3L.
    -Socio-labour adaptation: number of days off work.
    -Predictive factors:
    • Sociodemographic endpoints.
    • Quality of life and social adaptation at the time of diagnosis.
    • Clinical endpoints: oncological disease stage, onco-specific treatment (surgery, radiotherapy, chemotherapy and/or hormone therapy).
    •Psychosocial support.

    Biomarkers:
    -Functional neuroimaging (functional MR will evaluate the activity of certain brain structures such as ACC) and emotional processing with BMT: Response Predictors.

    Safety:
    -Number of patients with medical complications not directly related to the base disease.
    -Total number of adverse events.
    -Number of citalopram /psychological treatment related adverse events.
    Eficacia antidepresiva: Puntuación en el cuestionario de calidad de vida EQ-5D-3L.
    - Adaptación socio-laboral: número de días de baja laboral.
    - Factores predictivos:
    • Variables sociodemográficas.
    • Calidad de vida y adaptación social en el momento del diagnóstico.
    • Variables clínicas: estadio de la enfermedad oncológica, tratamiento oncoespecífico (cirugía, radioterapia, quimioterapia y/o hormonoterapia).
    • Soporte psicosocial.

    Biomarcadores:
    - Neuroimagen funcional (con la RMf se evaluará la actividad de determinadas estructuras cerebrales como el CCA) y procesamiento emocional con el BMT: Predictores de respuesta.

    Seguridad:
    - Número de pacientes con complicaciones médicas no directamente relacionadas con la enfermedad de base.
    - Número total de acontecimientos adversos
    - Número de acontecimientos adversos relacionados con el citalopram/tratamiento psicológico.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The assessment of the secondary end points is thoughout the study.
    La valoración de la variable principal es durante todo el estudio.
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    psicoterapia
    psychotherapy
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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
    Last visit last subject
    Último paciente última visita
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state40
    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)
    Patients at the end of the trial treatment will continue treatment according to usual clinical practice.
    Patients at the end of the trial treatment will continue treatment according to usual clinical practice.
    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 Decision2020-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-06-29
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