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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:2009-018195-33
    Sponsor's Protocol Code Number:D1443L00079
    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:2010-02-19
    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 number2009-018195-33
    A.3Full title of the trial
    Eficacia de quetiapina de liberación prolongada vs. placebo como terapia coadyuvante al tratamiento eutimizante en el control de los síntomas subsindrómicos del trastorno bipolar
    A.4.1Sponsor's protocol code numberD1443L00079
    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 SponsorCentro de Investigación Biomédica en Red en el Área de Salud Mental (CIBERSAM)
    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 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 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: 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 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.3.1Product nameSeroquel Prolong 300 mg comprimidos de liberación prolongada
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Terapia coadyuvante en el control de los síntomas subsindrómicos del trastorno bipolar
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11
    E.1.2Level LLT
    E.1.2Classification code 10057667
    E.1.2Term Trastorno  bipolar
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Ensayo clínico piloto cuyo objetivo principal es evaluar la eficacia de quetiapina de liberación prolongada (quetiapina LP) vs. placebo como terapia coadyuvante al tratamiento eutimizante (litio, valproato o lamotrigina) en el control de los síntomas subsindrómicos del trastorno bipolar.
    E.2.2Secondary objectives of the trial
    Evaluar la eficacia de quetiapina LP vs. placebo como terapia coadyuvante al tratamiento eutimizante:
    1.- Para alcanzar la remisión sintomática de los pacientes con síntomas subsindrómicos.
    2.-Para alcanzar la remisión sindrómica de los pacientes con síntomas subsindrómicos.
    3.-En el funcionamiento global de los pacientes con síntomas subsindrómicos.
    4.-En la calidad de vida de los pacientes con síntomas subsindrómicos.
    5.-Para alcanzar la remisión funcional de los pacientes con síntomas subsindrómicos.
    6.-Para alcanzar una mejoría temprana de los síntomas subsindrómicos depresivos.
    7.- Previo en los pacientes con síntomas subsindrómicos a lo largo de las 12 semanas de tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Firma del consentimiento informado.
    2. Edad mayor o igual 18 y menos o igual 65 años.
    3. Diagnostico de trastorno bipolar I o II (criterios DSM-IV-TR, 4ª Ed).
    4. Haber estado tratado con un estabilizador del estado de ánimo (litio, valproato o lamotrigina) a dosis estables y óptimas durante al menos las 6 semanas previas al inicio del ensayo (esto es, haber estado con la misma dosis y en niveles séricos dentro de los rangos terapéuticos: 0.6-1.2 mEq/l para el litio y 50-100 ug/ml para el valproato).
    5. Puntuación global de la MADRS mayor o igual 8 y menor o igual 14 y de la YMRS < 14 en las visitas de inclusión y aleatorización.
    6. Ser capaz de comprender y cumplir con los requerimientos del ensayo.
    7. Las pacientes de sexo femenino en edad potencial de procrear deberán estar empleando un método anticonceptivo fiable y tener resultado negativo en el test de hormona gonadotropa coriónica (hCG).
    E.4Principal exclusion criteria
    1. Mujeres embarazadas o en periodo de lactancia natural.
    2. Pacientes con retraso mental o que no sean capaces de comprender los requerimientos del ensayo.
    3. Haber presentado un episodio agudo del estado de ánimo (depresivo, maníaco o mixto) según criterios del DSM-IV-TR en las 8 semanas previas al inicio del ensayo.
    4. Pacientes con cualquier diagnóstico actual de los ejes I ó II del DSM-IV-TR diferente del de trastorno bipolar (incluyendo dependencia de sustancias o de abuso de alcohol en el momento de la inclusión en el ensayo, excepto si la dependencia está en fase de remisión completa. No se aplica a la nicotina ni a la cafeína). La ansiedad presente en niveles que no condicionen un diagnostico de trastorno de ansiedad codificado como tal en el DSM-IV no supondrá la exclusión del paciente del estudio.
    5. Abuso de opiáceos, anfetaminas, barbitúricos, cocaína, cannabis o sustancias alucinógenas según criterios DSM-IV-TR en las 4 semanas previas a la aleatorización
    6. Pacientes que, en opinión del investigador, tengan riesgo de suicidio o de auto o hetero-agresividad.
    7. Pacientes que se encuentren en tratamiento con más de un estabilizador del humor o con algún estabilizador del humor diferente de litio, valproato o lamotrigina en el momento de la aleatorización.
    8. Pacientes que se encuentren en tratamiento con algún antidepresivo y/o antipsicótico en el momento de la aleatorización (en el caso de fluoxetina, el periodo se amplía a las 5 semanas previas a la aleatorización).
    9. Tratamiento con algún antipsicótico depot dentro de un intervalo de dosis previo a la aleatorización.
    10. Estar o haber estado en tratamiento con algún inhibidor potente del citocromo P450-3A4 en los 14 días previos a la inclusión, incluyendo -aunque sin limitarse- a: ketoconazol, itraconazol, fluconazol, eritromicina, claritromicina, fluvoxamina, indinavir, nelfinavir, ritonavir y saquinavir.
    11. Estar o haber estado en tratamiento con algún inductor potente del citocromo P450-3A4 en los 14 días previos a la inclusión, incluyendo -aunque sin limitarse- a: fenitoína, carbamazepina, barbitúricos, rifampicina, hierba de San Juan y glucocorticoides.
    12. Cualquier contraindicación para el uso de fumarato de quetiapina o a los excipientes según lo dispuesto en la ficha técnica y en opinión del investigador (incluyendo falta de respuesta a algún intento de tratamiento previo, hipersensibilidad o intolerancia conocida).
    13. Padecer cualquier enfermedad médica qe pueda afectar significativamente a la absorción, distribución, metabolismo o excreción de los tratamientos del ensayo.
    14.Padecer cualquier enfermedad médica en descompensación o que no esté tratada apropiadamente en opinión del investigador (p.e., diabetes, angina de pecho, hipertensión, insuficiencia cardiaca congestiva, valores anormales de laboratorio clínicamente relevantes, etc).
    15. Paciente con Diabetes Mellitus (DM) que cumpla alguno de los criterios establecidos en el protocolo.
    16. Número absoluto de neutrófilos menor o igual 1.5 x 10(9) por litro.
    17. Participación en otro ensayo clínico en las 4 semanas previas a la aleatorización.
    18. Implicación en la planificación y/o realización del ensayo
    E.5 End points
    E.5.1Primary end point(s)
    Cambio en la puntuación global de la escala de Montgomery-Åsberg de depresión (MADRS) desde la visita basal hasta la semana 6 para cada uno de los grupos de tratamiento.
    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 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) Yes
    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 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 Yes
    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 concerned10
    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 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
    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 months1
    E.8.9.1In the Member State concerned 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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-02-19. Yes
    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 state80
    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 Decision2010-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
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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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