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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2004-001900-12
    Sponsor's Protocol Code Number:PFD-ESC
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2004-09-23
    Trial 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 number2004-001900-12
    A.3Full title of the trial
    ENSAYO CLINICA DOBLE CIEGO, ALEATORIZADO Y PARALELO SOBRE EL EFECTO DE ESCITALOPRAM vs REBOXETINA EN LA SENSIBILIDAD SOMATICA Y VISCERAL EN PACIENTES CON TRASTORNO DEPRESIVO MAYOR
    A.3.2Name or abbreviated title of the trial where available
    PFD-ESC
    A.4.1Sponsor's protocol code numberPFD-ESC
    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 SponsorSERVICIO DE PSIQUIATRIA. HOSPITAL UNIVERSITARI VALL D'HEBRON
    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 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 Information not present in EudraCT
    D.2.1.1.1Trade name CIPRALEX
    D.2.1.1.2Name of the Marketing Authorisation holderLUNDBECK
    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 nameCIPRALEX
    D.3.2Product code 246424
    D.3.4Pharmaceutical form Tablet
    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
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    D.2.1.1.1Trade name NOREBOX
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER
    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 nameNOREBOX
    D.3.2Product code 662387
    D.3.4Pharmaceutical form Tablet
    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 INNMESILATO DE REBOXETINA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    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.1.3Condition being studied is a rare disease Information not present in EudraCT
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Estudiar la sensibilidad somática y visceral en pacientes adultos con trastorno depresivo mayor (TDM) (criterios DSM-IV-TR). Para realizar este objetivo se incluirá un grupo control de 12 voluntarios sanos. La sensibilidad somática y visceral será valorada mediante el estudio, previo al inicio del tratamiento antidepresivo, de las siguientes variables:

    - Distensión rectal estandarizada.
    - Estimulación nerviosa eléctrica transcutánea.

    2. Comparar las modificaciones experimentadas en la sensibilidad somática y visceral del grupo tratado con escitalopram respecto al grupo con reboxetina, tras un tratamiento de 6 semanas.
    E.2.2Secondary objectives of the trial
    1. Estudiar, previo al inicio del tratamiento antidepresivo, la asociación existente entre la sintomatología depresiva (intensidad e ítems de la HAM-D) y la sensibilidad somática y visceral.

    2. Estudiar si existe una asociación entre los cambios en la gravedad de la sintomatología depresiva y los cambios en la sensibilidad somática y visceral después de 6 semanas de tratamiento con escitalopram o reboxetina.

    3. Identificar si las alteraciones en la sensibilidad somática y visceral pueden predecir la presencia de efectos secundarios de tipo digestivo en pacientes en tratamiento con escitalopram o reboxetina.

    4. Estudiar la eficacia del escitalopram vs la reboxetina en el tratamiento del TDM. Se considerará que un paciente responde a la medicación si la escala HAM-D disimuye a la sexta semana de tratamiento igual o más al 50% del valor basal.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    6.1.1 Criterios de inclusión para el grupo de pacientes con TDM

    1. Trastorno depresivo mayor, episodio único o recurrente, según criterios DSM-IV-TR.

    2. Duración del trastorno de como mínimo 4 semanas.

    3. Pacientes de ambos sexos, con edad superior o igual a los 18 años e inferior a los 65 años.

    4. Puntuación total antes de iniciar el tratamiento antidepresivo, igual o superior a 22 en la Escala de Hamilton para la Depresión de 21 ítems (HAM-D).

    5. Capacidad suficientemente comprobada para otorgar y firmar el correspondiente consentimiento informado.

    6. Lugar de residencia habitual compatible con la asistencia al centro.

    7. En caso de ser mujer, tomar medidas anticonceptivas eficaces.


    6.1.4 Criterios de inclusión para los sujetos control

    1. Sujetos de ambos sexos, con edad superior o igual a 18 años e inferior o igual a 65 años.

    2. Capacidad suficientemente comprobada para otorgar y firmar el correspondiente consentimiento informado.

    3. Lugar de residencia habitual compatible con la asistencia al centro.

    4. Puntuación total al inicio del estudio igual o inferior a 7 puntos en la Escala de Hamilton para la Depresión de 21 ítems (HAM-D).
    E.4Principal exclusion criteria
    6.2.1. Criterios de exclusión para los sujetos con TDM

    1. Diagnóstico de enfermedades médicas graves o antecedentes de patologías gastrointestinales que puedan interferir en el desarrollo del estudio.

    2. Antecedentes de hipersensibilidad a escitalopram, citalopram o reboxetina o alguno de sus excipientes.

    3. Historia de falta de respuesta antidepresiva a reboxetina o citalopram.

    4. Presencia de otro trastorno psiquiátrico en el Eje I del DSM-IV-TR.

    5. Presentar una puntuación igual o superior a 3 en el ítem suicidio de la HAM-D.

    6. Haber presentado un trastorno por abuso de sustancias dentro de los 6 meses previos a la inclusión en el estudio.

    7. Exposición a un tratamiento con terapia electroconvulsiva dentro de los 6 meses previos a la inclusión en el estudio.

    8. Fracaso en la respuesta antidepresiva en el episodio actual a más de un fármaco antidepresivo.

    9. Embarazo y lactancia natural.

    10. Tratamiento actual, o bien previsión de que el paciente deba iniciarlo durante el desarrollo del estudio, de medicamentos que interfieren en el ensayo. Si el paciente los tomó en el pasado será necesario el transcurso de un mínimo de dos semanas desde el abandono del tratamiento antes de iniciar su participación en el ensayo. En el caso de tratamiento con fluoxetina este periodo será de cinco semanas y para el resto de antidepresivos será de dos semanas.

    11. Participación actual o en los últimos 6 meses en otro proyecto de investigación.


    6.2.2. Criterios de exclusión para los sujetos del grupo control

    1. Presencia de un trastorno psiquiátrico del Eje I del DSM-IV-TR.

    2. Diagnóstico de enfermedades médicas graves o antecedentes de patologías gastrointestinales que puedan interferir en el desarrollo del estudio.

    3. Tratamiento actual, o bien previsión de que el paciente deba iniciarlo durante el desarrollo del estudio, de medicamentos que interfieren en el ensayo. Si el paciente los tomó en el pasado será necesario el transcurso de un mínimo de dos semanas desde el abandono del tratamiento antes de iniciar su participación en el ensayo. En el caso de tratamiento con fluoxetina este periodo será de cinco semanas y para el resto de antidepresivos será de dos semanas.
    E.5 End points
    E.5.1Primary end point(s)
    - Evaluación de la Sintomatología del Trastorno Depresivo Mayor: Escala de Hamilton para la Depresión de 21 ítems (HAM-D) y Beck Depresión Inventory (BDI).

    - Escala de Impresión Clínica Global (ICG).

    - Constantes vitales: peso, frecuencia cardiaca, tensión arterial sistólica y diastólica y temperatura.

    - Efectos indeseables.

    - Acontecimientos adversos.

    - Prueba de distensión rectal estandarizada: mediante la medida del umbral de molestia, medido en milímetros de mercurio.

    - Prueba de estimulación eléctrica transcutánea.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    El ensayo finalizará cuando se hayan incluido los 42 sujetos y hayan transcurridos las 6 semanas de tratamiento en todos ellos
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state42
    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 Decision2004-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-04-23
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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