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    Summary
    EudraCT Number:2011-003018-17
    Sponsor's Protocol Code Number:SPD489-322
    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:2012-08-07
    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 number2011-003018-17
    A.3Full title of the trial
    The SPD489-322 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination with an Antidepressant in the Treatment of Adults with Major Depressive Disorder with Inadequate Response to Prospective Treatment with an Antidepressant
    Estudio SPD489-322 de fase 3, multicéntrico, aleatorizado, doble ciego, de
    grupos paralelos y controlado con placebo, de ajuste de la dosis flexible, de
    la eficacia y la seguridad de SPD489 en combinación con un antidepresivo
    en el tratamiento de adultos con trastorno depresivo mayor con respuesta
    inadecuada al tratamiento prospectivo con un antidepresivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to examine the study drug, SPD489, in people with major depressive disorder (MDD) who are taking certain types of antidepressants and continuing to have MDD symptoms.
    Se trata de un ensayo para evaluar el fármaco del estudio, SPD489, en
    personas que sufren Trastorno Depresivo Mayor (TDM) que están tomando
    ciertos tipos de antidepresivos y que continúan teniendo síntomas de TDM.
    A.3.2Name or abbreviated title of the trial where available
    SPD489-322
    SPD489-322
    A.4.1Sponsor's protocol code numberSPD489-322
    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 SponsorShire Development LLC
    B.1.3.4CountryUnited States
    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 supportShire Development LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire Pharmaceuticals Ltd
    B.5.2Functional name of contact pointMedical Communications
    B.5.3 Address:
    B.5.3.1Street AddressHampshire International Business Park
    B.5.3.2Town/ cityChineham, Basingstoke, Hampshire
    B.5.3.3Post codeRG24 8EP
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+4408000556614
    B.5.5Fax number+4401256894714
    B.5.6E-mailmedinfoglobal@shire.com
    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 Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-33-3
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameNRP104
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.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 Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-33-3
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameNRP104
    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) 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.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 Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-33-3
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameNRP104
    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) 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.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 Vyvanse
    D.2.1.1.2Name of the Marketing Authorisation holderShire US Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameLisdexamfetamine dimesylate (LDX)
    D.3.2Product code SPD489
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLisdexamfetamine dimesylate
    D.3.9.1CAS number 608137-33-3
    D.3.9.2Current sponsor codeSPD489
    D.3.9.3Other descriptive nameNRP104
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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
    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
    D.8 Placebo: 4
    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
    Major Depressive Disorder
    Trastorno Depresivo Mayor
    E.1.1.1Medical condition in easily understood language
    Depression
    Depresión
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to demonstrate the efficacy of SPD489 when used as augmentation therapy in the treatment of major depressive disorder (MDD) in inadequate responders following an 8-week course of treatment with an antidepressant, as measured by the mean change in Montgomery-?sberg Depression Rating Scale (MADRS) total scores.
    El objetivo primario es demostrar la eficacia de SPD489 al utilizarse
    como terapia potenciadora para el tratamiento del trastorno depresivo
    mayor (TDM) en los pacientes que muestran una respuesta inadecuada
    tras 8 semanas de tratamiento con un antidepresivo (determinada
    mediante el cambio medio de la puntuación total en la Escala de
    valoración de la depresión de Montgomery y Asberg (MADRS).
    E.2.2Secondary objectives of the trial
    Key Secondary
    The key secondary objective is to demonstrate the effect of SPD489, when used as augmentation therapy in the treatment of MDD in inadequate responders following an 8-week course of treatment with an antidepressant, on quality of life (QoL) as measured by the Sheehan Disability Scale (SDS).

    Additional secondary objectives are described in the protocol.
    Secundario fundamental:
    El objetivo secundario fundamental es demostrar el efecto de SPD489 al
    utilizarse como terapia potenciadora para el tratamiento del trastorno
    depresivo mayor (TDM) en los pacientes que muestran una respuesta
    inadecuada tras 8 semanas de tratamiento con un antidepresivo, en
    cuanto a la calidad de vida (CdV) determinada mediante la Escala de
    discapacidad de Sheehan (EDS).

    Los objetivos secundarios adicionales se describen en el protocolo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject has a primary diagnosis of non-psychotic major depressive disorder (single or recurrent) as defined by the Structured Clinical Interview for DSM-IV-TR disorders ? Axis-I (SCID-CT) that has lasted ?8 weeks prior to the Screening Visit (Visit 1).

    Subject has a Montgomery Asburg Depression Rating Scale (MADRS) total score ?24 at the Lead-in Baseline Visit (Visit 2).
    El paciente tiene un diagnóstico primario de trastorno depresivo mayor
    no psicótico (único o recurrente), de acuerdo con la Entrevista Clínica
    Estructurada del Manual Diagnóstico y Estadístico de los Trastornos
    Mentales, Cuarta Edición - Revisión del Texto (SCID-CT), que se ha
    prolongado ? 8 semanas con anterioridad a la visita de selección (Visita
    1).
    El paciente presenta una puntuación total en la MADRS? 24 en la visita
    basal de inicio de antidepresivos (visita 2).
    E.4Principal exclusion criteria
    Subject whose current episode of MDD has not responded to an adequate
    treatment regimen (at least 6 weeks of treatment at the maximum
    tolerated adult dose approved for the indication) with 2 or more
    approved single antidepressant agents. Any subjects whose current
    episode of MDD has not responded to an approved adjunctive treatment
    strategy is to be excluded.

    Subject who has a lifetime history of treatment-resistant depression,
    defined as having not responded to adequate treatment (at least 8
    weeks at the maximum tolerated adult dose approved for the indication)
    with 2 or more treatment regimens, including, distinct classes of
    approved single antidepressant agents and adjunctive treatment
    stategies.

    Subject is considered a suicide risk in the opinion of the Investigator,
    has previously made a suicide attempt within the past 3 years, or is
    currently demonstrating active suicidal ideation.

    Subject has any current co-morbid psychiatric disorder that is either
    controlled with medications prohibited in this study or is uncontrolled
    and associated with significant symptoms. Excluded are: any significant
    Axis II disorders, any bipolar disorder, any current or lifetime psychosis,
    post-traumatic stress disorder, anorexia nervosa, and blumia nervosa. A
    history of serious cardiac problems that may place them at increased
    vulnerability to the sympathomimetic effects of a stimulant medication,
    a history of moderate to severe hypertension or an average (of 3
    readings) resting sitting systolic blood pressure >139mmHg or an
    average (of 3 readings) diastolic blood pressure >89mmHg the
    Screening Visit (Visit 1) and/or Lead-in Baseline Visit (Visit 2), or a
    concurrent chronic or acute illness or unstable medical condition that
    may deteriorate that could confound the results of safety assessments,
    increase risk to the subject, or lead to difficulty complying with the
    protocol.
    - Paciente cuyo episodio actual de trastorno depresivo mayor no ha
    respondido a un régimen de tratamiento adecuado (como mínimo 6
    semanas de tratamiento a la dosis máxima tolerada en adultos aprobada
    para la indicación) compuesto por dos o más fármacos antidepresivos
    únicos aprobados. Se excluirá todo paciente cuyo episodio de TDM no haya respondido a una estrategia de tratamiento adyuvante aprobada.
    -Pacientes con antecedentes de depresión resistente al tratamiento,
    definida como la ausencia de respuesta a un tratamiento adecuado
    (como mínimo 8 semanas de tratamiento a la dosis máxima tolerada en
    adultos aprobada para la indicación) con dos o más regímenes de
    tratamiento compuestos por fármacos antidepresivos únicos aprobados
    de distintas clases.
    - Paciente que en opinión del investigador se considera en riesgo de
    suicidio, ya ha llevado a cabo un intento de suicidio en los últimos 3
    años, o muestra actualmente pensamientos de suicido activos.
    - Pacientes que presentan otro trastorno psiquiátrico concomitante que: o bien se controla con medicamentos prohibidos en este estudio, o bien no está controlado y se asocia a síntomas significativos. Las patologías excluidas son: cualquier trastorno significativo del Eje II (incluyendo el trastorno límite de la personalidad), cualquier trastorno bipolar, cualquier psicosis (actual o aparecida durante la vida del paciente), trastorno de stress postraumático, trastorno obsesivo-compulsivo, anorexia nerviosa y bulimia nerviosa. Pacientes que tienen antecedentes de problemas cardíacos graves que podrían hacerlos más vulnerables a los efectos simpaticomiméticos de un medicamento estimulante. Pacientes con antecedentes de hipertensión moderada a grave, un promedio (de 3 lecturas) de la tensión arterial sistólica en sedestación > 139 mmHg o un promedio (de 3 lecturas) de la tensión arterial diastólica > 89 mmHg en la visita de selección (visita 1) o en la visita basal de inicio (visita 2). Pacientes que presenten una enfermedad concurrente aguda o crónica o una condición médica inestable que pudiera empeorar y dar lugar a errores en los resultados de las evaluaciones de seguridad, aumentar el riesgo para el paciente, o dar lugar a dificultades para cumplir con el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Augmentation Baseline Visit (Visit 8 [Week 8]) to Visit 14 (Week 16/Any) in Montgomery-Asberg Depression Rating Scale (MADRS) total score.
    Cambio en la puntuación total de EDS desde la visita basal del
    tratamiento de potenciación (Visita 8 [Semana 8]) hasta la Visita 14
    (Semana 16/otras) en la escala de clasificación de la depresión de
    Montgomery-?sberg (MADRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    ? Randomized Subjects: Week -4 to -1, 0, 6, 8, 9, 10, 11, 12, 14, 16/Any
    ? Non-Randomized Subjects: Week -4 to -1, 0, 6, 8, 10, 12, 16/Any
    ? Pacientes aleatorizados: Semana -4 a -1, 0, 6, 8, 9, 10, 11, 12, 14,
    16/otras
    ? Pacientes no aleatorizados: Semana -4 a -1, 0, 6, 8, 10, 12, 16/Otras
    E.5.2Secondary end point(s)
    1) Change from the Augmentation Baseline Visit (Visit 8 [Week 8]) to Visit 14 (Week 16/Any) in Sheehan Disabillity Scale (SDS) total score.
    2) Safety and tolerability as based on a) occurrence of treatment-emergent adverse events (TEAEs), b) response to Columbia Suicide Severity Rating Scale (C-SSRS), evaluations of blood pressure and pulse, c) clinical laboratory evalutions, and d) electrocardiograms (ECG)
    3) Percent of Participants Achieving a 25% Response on the MADRS at Visit 14 (Week 16/Any)
    4) Percent of Participants Achieving a 50% Response on the MADRS at Visit 14 (Week 16/Any)
    5) Percent of Participants Achieving Remission on the MADRS at Visit 14 (Week 16/Any)
    6) Change from Augmentation Baseline Visit (Visit 8 [Week 8]) over time in MADRS total score.
    7) Change in the Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR)
    8) Change from the Augmentation Baseline Visit (Visit 8 [Week 8]) to Visit 14 (Week 16/Any) in the Short Form-12 Health Survey V2 (SF-12V2)
    9) Change from the Augmentation Baseline Visit (Visit 8 [Week 8]) to Visit 14 (Week 16/Any) in the EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L index score)
    10) Change from the Augmentation Baseline Visit (Visit 8 [Week 8]) to Visit 14 (Week 16/Any) in the Quality of Life Enjoyment Satisfaction Questionnaire Short Form (QLES-Q-SF)
    11) Clinical Global Impressions - Severity of Illness (CGI-S) at Visit 2 (Week 0) and Visit 8 (Week 8)
    12) Change in Clinical Global Impressions - Global Improvement (CGI-I) at Visit 14 (Week 16/Any)
    13) Change in the Patient Resource Utilization Questionnaire (PRUQ)
    14) Amphetamine Cessation Symptom Assessment (ACSA) at Visit 15 (Week 17/Any)
    1)Cambio en la puntuación total Escala de discapacidad de Sheehan
    (EDS) desde la visita basal del tratamiento de potenciación (Visita 8
    [Semana 8]) hasta la Visita 14 (Semana 16/otras)
    2) Evaluar la Seguridad y tolerabilidad basados en a) la aparición de
    acontecimientos adversos emergentes relacionados con el tratamiento
    (AASDT), b) la respuesta a la Escala Columbia para evaluar el riesgo de
    suicidio, Columbia Suicide Severity Rating Scale (C-SSRS), c)
    evaluaciones clínicas de laboratorio, y d) electrocardiogramas (ECG)
    3) porcentaje de pacientes que alcanzan un 25% en la Respuesta al
    MADRS en la Visita 14 (Semana16/Otras)
    4) porcentaje de pacientes que alcanzan un 50% en la Respuesta al
    MADRS en la Visita 14 (Semana16/Otras)
    5) Porcentaje de pacientes que consigan la Remisión en la Respuesta al
    MADRS en la Visita 14 (Semana16/Otras)
    6) Cambio desde la visita basal del tratamiento de potenciación (Visita 8
    [Semana 8]) a lo largo del tiempo en la puntuación total de MADRS.
    7) Cambio en el Inventario rápido de la sintomatología depresiva -
    autoinforme (QIDS-SR).
    8) Cambio desde la la inicial del tratamiento de potenciación (Visita 8
    [Semana 8]) a la Visita 14 (Seamana 16/Otras) en la encuesta de salud
    SF-12 versión 2, forma breve (SF-12V2) .
    9) Cambio desde la la inicial del tratamiento de potenciación (Visita 8
    [Semana 8]) a la Visita 14 (Semana 16/Otras) en el cuestionario de
    autoevaluación del grupo EuroQOL de 5 dimensiones y 5 niveles (EQ-5D-
    5L).
    10) Cambio desde la la inicial del tratamiento de potenciación (Visita 8
    [Semana 8]) a la Visita 14 (Semana 16/Otras) el Cuestionario de calidad
    de vida, satisfacción y placer, forma breve (Q LES-Q-SF).
    11) Impresión Clínica Global - Mejoría Global (ICG-MG) en la Visita 2
    (Semana 0) y Visita 8 (Semana 8).
    12) Cambio en la Impresión Clínica Global - Mejoría Global (ICG-MG) en
    la Visita 14 (Semana 16/Otras)
    13) Cambio en el cuestionario de utilización de recursos del paciente
    (Patient Resource Utilization Questionnaire (PRUQ))
    14) Evaluación de los síntomas de abandono de las anfetaminas (ACSA)
    en la Visita 15 (Semana 17/Otras)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 ) SDS
    ? Randomized (R): Week (Wk) 0, 8, 9, 10, 11, 12, 14, 16/Any
    ? Non-randomized (NR): 0, 8, 10, 12, 16/Any

    2a)
    ? R: Wk 8, 9, 10, 11, 12, 14, 16/Any, 17/Any
    ? NR: 8, 10, 12, 16/Any, 17/Any
    2b)
    ? R: Wk -1 to -4, 0, 1, 2, 3, 4, 6, 8, 9, 10, 11, 12, 14, 16/Any, 17/Any
    ? NR: -1 to -4, 0, 1, 2, 3, 4, 6, 8, 10, 12, 16/Any, 17/Any
    2c)
    ? R & NR: Wk -4 to -1, 0, 8, 12, 16/Any
    2d)
    ? R & NR: Wk -4 to -1, 0, 8, 16/Any
    3-6)
    ? R: Wk -4 to -1, 0, 6, 8, 9, 10, 11, 12, 14, 16/Any
    ? NR: -4 to -1, 0, 6, 8, 10, 12, 16/Any
    7-10) R & NR: Wk 0, 8, 16/Any
    11) R & NR: Week 0 and 8
    12)
    ? R: Wk 1, 2, 3, 4, 6, 8, 9, 10, 11, 12, 14, 16/Any
    ? NR: 1, 2, 3, 4, 6, 8, 10, 12, and 16/Any
    13) R & NR: Wk 0, 8, 12, 16/Any
    14) R & NR: Wk 17/Any
    1 ) EDS-Escala de discapacidad de Sheehan
    ? Aleatorizados (A): Semana (Sem) 0, 8, 9, 10, 11, 12, 14, 16/Otra
    ? No aleatorizados (NA): 0, 8, 10, 12, 16/Otras
    2a)
    ? A: Sem 8, 9, 10, 11, 12, 14, 16/Otras, 17/Otras
    ? NA: 8, 10, 12, 16/Otra, 17/Otras
    2b) ? A: Sem -1 a -4, 0, 1, 2, 3, 4, 6, 8, 9, 10, 11, 12, 14, 16/Otras,
    17/Otras
    ? NA: -1 a -4, 0, 1, 2, 3, 4, 6, 8, 10, 12, 16/Otras, 17/Otras
    2c)
    ? A y NA: Sem -4 a -1, 0, 8, 12, 16/Otras
    2d)
    ? A y NA: Sem -4 a -1, 0, 8, 16/Otras
    3-6) ? A: Sem -4 a -1, 0, 6, 8, 9, 10, 11, 12, 14, 16/Otras
    ? NA: -4 a -1, 0, 6, 8, 10, 12, 16/Otras
    7-10) A y NA: Sem 0, 8, 16/Otras
    11) A y NA: Sem 0 y 8
    12) ? A: Sem 1, 2, 3, 4, 6, 8, 9, 10, 11, 12, 14, 16/Otras
    ? NA: 1, 2, 3, 4, 6, 8, 10, 12, y 16/Otras
    13) A y NA: Sem 0, 8, 12, 16/Otras
    14) A y NA: Sem 17/Otras
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Withdrawal symptoms
    Síntomas de abstinencia
    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) 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 Yes
    E.8.1.7.1Other trial design description
    Flexible Dose Titration
    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.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Croatia
    France
    Mexico
    Spain
    United States
    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 Subject Last Visit
    Último Paciente Última Visita
    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 months8
    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 months8
    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 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: 1012
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 1034
    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)
    Eligible subjects will have the option to enter a 12-month extension safety and tolerability study.
    Los pacientes elegibles tendrán la opción de continuar en un estudio
    de extensión de 12 meses de duración para evaluar la seguridad y la
    tolerabilidad.
    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 Decision2012-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-23
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