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    Summary
    EudraCT Number:2010-020579-21
    Sponsor's Protocol Code Number:D1443L00082
    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:2010-07-29
    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 number2010-020579-21
    A.3Full title of the trial
    Ensayo Clínico fase IV aleatorizado, prospectivo, doble ciego, enmascarado, cruzado para evaluar el impacto diario en la función cognitiva del fumarato de Quetiapina de liberación inmediata (Seroquel®) dos veces al día y fumarato de Quetiapina de liberación prolongada (Seroquel Prolong®) una vez al día por la noche en pacientes estables con esquizofrenia. A Phase IV Prospective, Double-blind, Double-dummy, Randomised, Crossover Study to Assess the Impact on Daily Cognitive Functioning of Quetiapine Fumarate Immediate Release (Seroquel IR®) Dosed twice Daily and Quetiapine Fumarate Extended Release (Seroquel XR®) Dosed once Daily in the Evening in Patients with Stable Schizophrenia
    A.4.1Sponsor's protocol code numberD1443L00082
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 SEROQUEL 25 mg comprimidos recubiertos con pelicula
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA FARMACEUTICA SPAIN, 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 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 INNQUETIAPINA FUMARATO
    D.3.9.3Other descriptive nameQUETIAPINE FUMARATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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 SEROQUEL 100 mg comprimidos recubiertos con pelicula
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA FARMACEUTICA SPAIN, 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 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 INNQUETIAPINA FUMARATO
    D.3.9.3Other descriptive nameQUETIAPINE FUMARATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 SEROQUEL 200 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA FARMACEUTICA SPAIN, 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 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 INNQUETIAPINA FUMARATO
    D.3.9.3Other descriptive nameQUETIAPINE FUMARATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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: 4
    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 SEROQUEL PROLONG 50 mg comprimidos de liberación prolongada
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA FARMACEUTICA SPAIN, 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 Prolonged-release 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 INNQUETIAPINA FUMARATO
    D.3.9.3Other descriptive nameQUETIAPINE FUMARATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 5
    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 SEROQUEL PROLONG 200 mg comprimidos de liberación prolongada
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA FARMACEUTICA SPAIN, 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 Prolonged-release 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 INNQUETIAPINA FUMARATO
    D.3.9.3Other descriptive nameQUETIAPINE FUMARATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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: 6
    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 SEROQUEL PROLONG 300 mg comprimidos de liberación prolongada
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA FARMACEUTICA SPAIN, 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 Prolonged-release 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 INNQUETIAPINA FUMARATO
    D.3.9.3Other descriptive nameQUETIAPINE FUMARATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 placeboTablet
    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 placeboTablet
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 4
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 5
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 6
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    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
    Esquizofrenia. Schizophrenia
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10039626
    E.1.2Term Schizophrenia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este ensayo es demostrar que los pacientes con esquizofrenia estable presentan un rendimiento cognitivo diurno superior cuando toman quetiapina de liberación prolongada (LP) una vez al día por la noche que cuando toman quetiapina de liberación inmediata (LI) dos veces al día, empleando para ello los dominios de Detección (velocidad de procesamiento) e Identificación (atención/vigilancia) de las pruebas CogState, realizadas conforme a las instrucciones actuales.
    E.2.2Secondary objectives of the trial
    - Evaluar la seguridad y la tolerabilidad durante el tratamiento con quetiapina LP y con quetiapina LI, administradas según la ficha técnica a pacientes con esquizofrenia estable, mediante la incidencia de acontecimientos adversos (AA) y los cambios de los valores de laboratorio, las constantes vitales y el peso desde la inclusión hasta el final del ensayo
    - Evaluar la satisfacción con el tratamiento de los pacientes con esquizofrenia estable tratados con quetiapina LP y con quetiapina LI, mediante el Cuestionario de satisfacción con la medicación (TSQM: Treatment Satisfaction Questionnaire of Medication)
    - Evaluar las diferencias de rendimiento cognitivo diurno con quetiapina LI y quetiapina LP, administradas según la ficha técnica, utilizando las pruebas CogState:
    - Una antes (memoria de trabajo)
    - Tarea de la lista de la compra internacional (aprendizaje verbal)
    - Prueba de aprendizaje del laberinto de Groton (razonamiento y resolución de problemas)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Obtención del consentimiento informado por escrito antes de cualquier procedimiento específico del ensayo
    2. Pacientes de ambos sexos y >/=18 y </= 50 años de edad
    3. Diagnóstico clínico documentado de esquizofrenia de tipo paranoide durante al menos 2 años antes de la aleatorización, que cumpla los criterios del “Manual diagnóstico y estadístico de los trastornos mentales, 4.a edición” (DSM-IV, American Psychiatric Association 2000) para la esquizofrenia (DSM-IV, códigos 295.3) y que esté confirmado con el MINI versión 5.0
    4. Pacientes hospitalizados menos de 7 veces a causa de la esquizofrenia
    5. Puntuación PANSS </= 65 en la inclusión (visita 1) e ICG-G </= 3 es decir, enfermedad leve, y los síntomas deben permanecer estables durante las 4 últimas semanas antes de la aleatorización a juicio del investigador
    6. Los pacientes deben ser capaces de entender y cumplir los requisitos del ensayo, a juicio del investigador
    7. Pacientes ambulatorios en el momento de la inclusión
    8. Período de 56 días (8 semanas) de situación psiquiátrica estable antes de la aleatorización
    E.4Principal exclusion criteria
    1. Diagnóstico de cualquier trastorno del eje I del DSM-IV distinto de los incluidos en los criterios de inclusión ya citados en el plazo de 6 meses antes de la aleatorización (por ejemplo, dependencia del alcohol o dependencia de sustancias psicoactivas sin remisión completa, trastorno mental orgánico concurrente o retraso mental [diagnóstico del eje II]) en grado que pueda interferir con la capacidad del paciente para cooperar.
    2. Pacientes con abuso o dependencia de sustancias según lo definido por los criterios del DSM-IV y sin remisión completa si el abuso o dependencia de sustancias le hayan causado anteriormente deterioro cognitivo. Se realizará una prueba de detección de drogas en orina en el momento de la inclusión. El investigador evaluará los resultados toxicológicos junto con la historia clínica para determinar si el paciente cumple o no con los criterios del DSM-IV relativos al abuso de sustancias. Los pacientes serán excluidos a partir de un único resultado positivo del análisis toxicológico en orina (ATO) para cocaína, heroína o PCP
    3. Uso estable previo de dosis elevadas de benzodiazepinas durante un año o más
    4. Pacientes con >2 episodios psicóticos con hospitalización en los 6 meses previos a la aleatorización
    5. Uso de fármacos que induzcan o inhiban claramente las enzimas hepáticas (CYP) 3A4 del citocromo metabolizador P450 en los 14 días previos a la aleatorización. Inductores prohibidos: carbamazepina, fenitoína, barbitúricos, rifampicina, rifabutina, glucocorticoides orales, tioridazina e hipérico. Inhibidores prohibidos: ketoconazol (salvo uso tópico), itraconazol, fluconazol, eritromicina, claritromicina, indinavir, nelfinavir, ritonavir, fluvoxamina, nefazodona, troleandomicina, y saquinavir.
    6.Uso de los siguientes medicamentos:
    - otro antipsicótico distinto de quetiapina en los 28 días previos a la aleatorización
    - una inyección de antipsicóticos depot en dos intervalos posológicos (para el depot) antes de la aleatorización (Visita 2)
    - otros fármacos psicoactivos en los 14 previos a la aleatorización (hipnóticos o ansiolíticos distintos de los permitidos; véase la Tabla 6)7. Uso de tratamientos concomitantes que probablemente afecten a la cognición
    Medicación prohibida 28 días antes de la aleatorización: benzodiazepinas, anfetaminas, reboxitina, atomoxinetina, buspirona, donepezilo, duloxetina, galantamina, ginko biloba, memantina, metilfenidato, modafinilo, rivastigmina, tacrina, varenciclina para dejar de fumar y cualquier forma farmacéutica que sirva como tratamiento sustitutivo de la nicotina
    Medicación prohibida 14 días antes de la aleatorización: inhibidores de la monoaminooxidasa (IMAO) irreversibles, antidepresivos tricíclicos (ATC), biperideno, fármacos anticolinérgicos (aunque las indicaciones sean síntomas extrapiramidales o síntomas urinarios)
    8. Inhibidor selectivo de la recaptación de serotonina (ISRS) e inhibidor de la recaptación de serotonina/noradrenalina (IRSN) (permitido en caso dosis estable, por ejemplo, si la dosis no ha cambiado en los 28 previos a la aleatorización y no se prevé ningún cambio durante la realización del ensayo; véase la sección 5.6, Tabla 6)
    9.Las contraindicaciones que se detallen en la ficha técnica de quetiapina en cada país.
    10.Deterioro de la visión o la audición que dificulte la evaluación cognitiva a juicio del investigador
    11.Antecedentes de cualquier enfermedad maligna en los 2 años anteriores a la aleatorización excepto las enfermedades cutáneas superficiales leves a juicio del investigador (ej, carcinoma de células basales y carcinoma epidermoide).
    12. Tratamiento electroconvulsivo (TEC) en los 90 días previos a la aleatorización (Visita 2)
    13. Pacientes que en opinión del investigador requieran una psicoterapia formal durante el período del ensayo, a menos que ya lleven en psicoterapia un mínimo de 90 días antes de la aleatorización (Visita 2)
    14. Pacientes que, a juicio del investigador, presenten actualmente un grave riesgo de suicidio u homicidio, o que hayan cometido un intento de suicidio en los 6 últimos meses antes de la aleatorización
    15. Embarazo o lactancia
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal será el rendimiento relativo en las pruebas cognitivas CogState, batería n.º 1 –tarea de detección (velocidad de procesamiento) y tarea de identificación (atención/vigilancia)–, determinado mediante una puntuación combinada normalizada de los pacientes tratados con quetiapina LP una vez al día por la noche y con quetiapina LI dos veces al día. La puntuación combinada del cambio podrá derivarse de las puntuaciones en cada una de las tareas.
    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 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 No
    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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    doble simulación
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    N/A
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    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 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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    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)
    N/A
    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 Decision2010-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-02
    P. End of Trial
    P.End of Trial StatusOngoing
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