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    Summary
    EudraCT Number:2008-002319-42
    Sponsor's Protocol Code Number:F1J-EW-HMGD
    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:2008-09-23
    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 number2008-002319-42
    A.3Full title of the trial
    Comparación de dos estrategias de tratamiento diferentes en pacientes con trastorno depresivo mayor en tratamiento con escitalopram que no presentan mejoría: Estrategia de intervención temprana versus estrategia de intervención tardía

    Comparison of Two Different Treatment Strategies in Patients with Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy
    A.3.2Name or abbreviated title of the trial where available
    HMGD
    A.4.1Sponsor's protocol code numberF1J-EW-HMGD
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLilly S.A.
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 CYMBALTA 30 mg cápsulas duras gastrorresistentes
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NETHERLAND BV
    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.3.4Pharmaceutical form Gastro-resistant capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDULOXETINA HIDROCLORURO
    D.3.9.3Other descriptive nameDULOXETINA HIDROCLORURO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 RoleComparator
    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 CIPRALEX 10 mg comprimidos con cubierta pelicular
    D.2.1.1.2Name of the Marketing Authorisation holderLUNDBECK ESPAÑA, S.A.
    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.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNESCITALOPRAM OXALATO
    D.3.9.3Other descriptive nameESCITALOPRAM OXALATE
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 CYMBALTA 60 mg cápsulas duras gastrorresistentes
    D.2.1.1.2Name of the Marketing Authorisation holderELI LILLY NETHERLAND BV
    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.3.4Pharmaceutical form Gastro-resistant capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNDULOXETINA HIDROCLORURO
    D.3.9.3Other descriptive nameDULOXETINA HIDROCLORURO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    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
    Trastorno depresivo mayor
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10025453
    E.1.2Term Major depressive disorder NOS
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Este estudio tiene dos objetivos principales: 1) Evaluar la hipótesis de que el tiempo transcurrido hasta que se produzca la respuesta confirmada es menor cuando se aplica la estrategia de intervención temprana, en comparación con la estrategia de intervención tardía, en pacientes que sufren TDM y que no presentan mejoría tras 4 semanas de tratamiento con escitalopram, y 2) evaluar la hipótesis de que el tiempo transcurrido hasta que se produzca la remisión confirmada será menor en la estrategia
    E.2.2Secondary objectives of the trial
    Comparar la eficacia de ambas estrategias de intervención, medidas por el tiempo transcurrido hasta: La respuesta confirmada, definida como una reducción >/= 50% en la puntuación basal de la escala QIDS-SR, que se mantenga en dos visitas consecutivas. La remisión confirmada, definida como una puntuación en la QIDS-SR </= 5 que se mantenga en dos visitas consecutivas.
    Comparar la eficacia a lo largo del estudio de ambas estrategias, medido mediante las escalas CGI-S, EVA, HAMD17, SDS, CPFQ, EQ-5D, sus costes directos e indirectos, y la seguridad de ambas estrategias medidas por AAST y AAG
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    [1] Pacientes ambulatorios de ambos sexos, de al menos 18 años de edad, que cumplan los criterios de episodio único o recurrente de TDM, según los criterios diagnósticos de la enfermedad del DSM-IV®-TR.
    [2] Pacientes (independientemente de que estén recibiendo tratamiento antidepresivo) que, según los criterios del investigador, comiencen en la visita 1 tratamiento con escitalopram o cambien su tratamiento antidepresivo actual a escitalopram, para tratar el episodio actual de TDM.
    [3] Deben presentar en la visita 1 una puntuación basal en la escala HAM-D17 >/=19.
    [4] Deben presentar en la visita 1 una puntuación basal en la Escala de la impresión clínica global de gravedad (CGI-S) >/= 4.
    [5] Deben tener un nivel suficiente de entendimiento para proporcionar el ICD, y para comunicarse con el investigador y el personal del centro.
    [6] Han de considerarse fiables, y estar de acuerdo en acudir a todas las visitas clínicas y en realizar los procedimientos requeridos en el protocolo.
    E.4Principal exclusion criteria
    [7] Presentar en la actualidad un trastorno primario del eje I (excepto el TDM), incluida la distimia.
    [8] Presentar un diagnóstico de demencia, enfermedad de Alzheimer o síndrome cerebral orgánico; o presentar disfunción cognitiva o problemas de lenguaje que les impidan entender y / o proporcionar respuestas válidas a las escalas de evaluación.
    [9] Participar simultáneamente en otros estudios con productos en investigación o comercializados.
    [10] No se prevea que puedan ser monitorizados durante la totalidad del período del estudio por razones no relacionadas con su enfermedad (por ejemplo, cambio de domicilio o centro de salud de referencia).
    [11] Hayan presentado o estén presentado una respuesta al tratamiento antidepresivo del episodio depresivo actual previamente a la visita basal.
    [12] Ser personal del centro del estudio directamente relacionado con el estudio y/o familiares cercanos. La familia inmediata se define como el cónyuge, los padres, los hijos o los hermanos, tanto naturales como adoptados legalmente.
    [13] Ser empleados de Lilly o de Boehringer Ingelheim (BI) (es decir, trabajadores con un contrato fijo o temporal o representantes responsables de la ejecución del estudio). Los familiares inmediatos de los trabajadores de Lilly o de BI podrán participar en los ensayos clínicos promovidos por Lilly o BI pero no dentro de las instalaciones de Lilly o BI. La familia inmediata se define como el cónyuge, los padres, los hijos o los hermanos, tanto naturales como adoptados legalmente.
    [14] Mujeres en edad fértil que no utilicen un método anticonceptivo médicamente aceptado (por ejemplo, dispositivo intrauterino, anticonceptivo oral, parche anticonceptivo, implante, Depo-Provera ® [suspensión inyectable de acetato de medroxiprogesterona, Pharmacia & Upjohn], o dispositivos de barrera) cuando mantengan relaciones sexuales. Las mujeres embarazadas o en periodo de lactancia no deberán participar en el estudio.
    [15] Haber recibido tratamiento en los últimos 30 días con un fármaco que no haya recibido la aprobación de las autoridades reguladoras para ninguna indicación en el momento de la inclusión en el estudio.
    [16] Presentar, según el criterio del investigador, un riesgo grave de suicidio, y/o presentar una puntuación basal (visita 1) en el ítem 3 de la escala HAMD17 >/= 3.
    [17] Haber recibido tratamiento con un inhibidor de la monoamino-oxidasa (IMAO) dentro de los 14 días previos a la visita 1, o ser susceptible de utilizar un IMAO durante el estudio, o en los 5 días posteriores a la discontinuación de la administración del fármaco del estudio.
    [18] Requerir que se inicie o se interrumpa la psicoterapia dentro de las 6 semanas previas al reclutamiento (visita 1) o en cualquier momento durante el estudio.
    [19] Presentar cualquier contraindicación para el uso de duloxetina, basándose en el Resumen de Características del Producto de duloxetina (RCP), o cualquier contraindicación para el uso de escitalopram, basándose en el RCP de escitalopram.
    [20] Presentar antecedentes de falta de respuesta a duloxetina o escitalopram, en dosis clínicamente adecuadas, durante un mínimo de 4 semanas, o haber finalizado o haber sido retirado previamente de este estudio o de cualquier otro estudio en el que se investigue duloxetina o escitalopram.
    [21] Presentar diagnóstico previo de trastorno bipolar, esquizofrenia u otros trastornos psicóticos.
    [22] Antecedentes de abuso o dependencia de sustancias (según los criterios del DSM-IV) dentro del último año, con excepción de la nicotina y la cafeína.
    [23] Sufrir enfermedades cardiovasculares, hepáticas, renales, respiratorias o hematológicas, graves o inestables; enfermedad vascular periférica sintomática u otro trastorno médico (incluida la hipertensión inestable y la ausencia de eutiroidismo clínico) o psicológico que, en opinión del investigador, dificulte la participación o pueda provocar la hospitalización durante el transcurso del estudio.
    [24] Haber recibido terapia electroconvulsiva o estimulación magnética transcraneal durante el año previo.
    E.5 End points
    E.5.1Primary end point(s)
    Este estudio tiene dos criterios principales de valoración: 1) el tiempo transcurrido hasta la respuesta confirmada, definida como >/= 50% de reducción en la puntuación basal de la escala HAMD17, que se mantenga durante dos visitas consecutivas, y 2) el tiempo transcurrido hasta la remisión confirmada, definida como una puntuación </= 7 en la escala HAMD17, que se mantenga durante dos visitas consecutivas.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    estrategia de intervencion temprana vs estrategia intervencion tardia
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA59
    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 Information not present in EudraCT
    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
    Ultima visita del ultimo paciente del estudio
    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 months7
    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 months7
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1160
    F.4.2.2In the whole clinical trial 1160
    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)
    El tratamiento a seguir despues de la finalizacion del estudio sera el que administre el medico responsable
    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 Decision2008-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-03-08
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