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    Summary
    EudraCT Number:2010-018860-17
    Sponsor's Protocol Code Number:31-08-257
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-10-25
    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 number2010-018860-17
    A.3Full title of the trial
    A Multicenter, 52-week, Open-label Study to Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients with Major Depressive Disorder
    Estudio multicéntrico, abierto, de 52 semanas de duración, para evaluar la eficacia y tolerabilidad de un tratamiento combinado de aripiprazol y escitalopram por vía oral en pacientes con trastorno de depresión mayor
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A global study to see how safe, effective and well tolerated a capsule containing Aripiprazole and Escitalopram is in people with depression.
    Estudio global para evaluar el nivel de seguridad, efectividad y tolerabilidad de una cápsula que contiene aripiprazol y escitalopram, en personas que sufren depresión.
    A.3.2Name or abbreviated title of the trial where available
    ACES 257
    ACES 257
    A.4.1Sponsor's protocol code number31-08-257
    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 SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
    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 supportOtsuka Pharmaceutical Development and Commercialization, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCovance
    B.5.2Functional name of contact pointDorota Plewicka, MD
    B.5.3 Address:
    B.5.3.1Street AddressStoretungrova 36
    B.5.3.2Town/ cityForde
    B.5.3.3Post code6800
    B.5.3.4CountryNorway
    B.5.4Telephone number+47578213 25
    B.5.5Fax number+4822 627 69 40
    B.5.6E-maildorota.plewicka@covance.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 No
    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 nameAripiprazole/Escitalopram 3-10 mg Combination Capsule
    D.3.2Product code OPC-14597
    D.3.4Pharmaceutical form Capsule
    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 INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Available
    D.3.9.1CAS number 219861-08-2
    D.3.9.3Other descriptive nameESCITALOPRAM OXALATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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 No
    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 nameAripiprazole/Escitalopram 3-20 mg Combination Capsule
    D.3.2Product code OPC-14597
    D.3.4Pharmaceutical form Capsule
    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 INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 219861-08-2
    D.3.9.3Other descriptive nameESCITALOPRAM OXALATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration 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: 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 No
    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 nameAripiprazole/Escitalopram 6-10 mg Combination Capsule
    D.3.2Product code OPC-14597
    D.3.4Pharmaceutical form Capsule
    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 INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 219861-08-2
    D.3.9.3Other descriptive nameESCITALOPRAM OXALATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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 No
    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 nameAripiprazole/Escitalopram 6-20 mg Combination Capsule
    D.3.2Product code OPC-14597
    D.3.4Pharmaceutical form Capsule
    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 INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 219861-08-2
    D.3.9.3Other descriptive nameESCITALOPRAM OXALATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration 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: 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 No
    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 nameAripiprazole/Escitalopram 12-10 mg Combination Capsule
    D.3.2Product code OPC-14597
    D.3.4Pharmaceutical form Capsule
    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 INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 219861-08-2
    D.3.9.3Other descriptive nameESCITALOPRAM OXALATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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: 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 No
    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 nameAripiprazole/Escitalopram 12-20 mg Combination Capsule
    D.3.2Product code OPC-14597
    D.3.4Pharmaceutical form Capsule
    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 INNARIPIPRAZOLE
    D.3.9.1CAS number 129722-12-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 219861-08-2
    D.3.9.3Other descriptive nameESCITALOPRAM OXALATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration 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.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
    Major Depressive Disorder (MDD)
    Trastorno de depresión mayor
    E.1.1.1Medical condition in easily understood language
    Depression
    Depresión
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    E.1.2Level LLT
    E.1.2Classification code 10025454
    E.1.2Term Major depressive disorder, recurrent episode
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the 52-week safety and tolerability of an oral aripiprazole/escitalopram combination therapy in the treatment of patients with MDD.
    Evaluar la seguridad y tolerabilidad durante 52 semanas de un tratamiento combinado con aripiprazol y escitalopram por vía oral en pacientes con MDD.
    E.2.2Secondary objectives of the trial
    N/A
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who are able to provide written informed consent and/or
    consent obtained from a legally acceptable representative (as required
    by IRB/IEC), prior to the initiation of any protocol-required procedures.
    2. Ability, in the opinion of the principal investigator, to understand the
    nature of the study and follow protocol requirements, including the
    prescribed dosage regimens, tablet/capsule ingestion, and discontinuation of prohibited concomitant medication; to read and
    understand the written word in order to complete subject-reported
    outcomes measures; and to be reliably rated on assessment scales.
    3. Male or female outpatients 18 to 66 years of age, inclusive, at the time
    of informed consent.
    4. Subjects who have participated in Protocol 31-08-255, 31-08-256 or
    31-08-263 and who, in the opinion of the investigator, could potentially
    benefit form the administration of oral aripiprazole/escitalopram
    combination therapy. Eligible subjects include those who:
    a) completed participation in the Randomization Phase (Phase C, Week
    14 Visit) or
    b) met criteria for a response at the end of the Prospective treatment
    Phase (Phase B, Week 8 Visit) and at the end of Phase B+ (Week 14
    Visit) did not meet criteria for remission (defined as a MADRS Total
    Score =<10).
    1. Pacientes que puedan proporcionar el consentimiento informado por escrito u obtención del consentimiento de un representante legalmente aceptable (según lo requiera el IRB/IEC), antes de comenzar ningún procedimiento requerido por el protocolo.
    2. Capacidad, según la opinión del investigador principal, de comprender la naturaleza del estudio y cumplir los requisitos del protocolo, inclusive los regímenes posológicos prescritos, la toma de comprimidos o cápsulas y la interrupción de los medicamentos concomitantes prohibidos; también de leer y comprender textos escritos para poder rellenar las mediciones de resultados comunicados por el paciente y recibir una puntuación fiable en las escalas de evaluación.
    3. Pacientes ambulatorios de ambos sexos de 18 a 66 años de edad, ambas inclusive, en el momento del consentimiento informado.
    4. Pacientes que hayan participado en los protocolos 31-08-255, 31-08-256 o 31-08-263 y que, en la opinión del investigador, podrían obtener beneficios de la administración del tratamiento combinado con aripiprazol o escitalopram por vía oral. Los pacientes elegibles son los que: a) completaron su participación en la fase de aleatorización (fase C, visita de la semana 14) o b) cumplen los criterios de respuesta al final de la fase de tratamiento prospectivo (fase B, visita de la semana 8) y, al finalizar la fase B+ (visita de la semana 14), no cumplen los criterios de remisión (definida como una puntuación MADRS total =<10).
    E.4Principal exclusion criteria
    Sex and Reproductive Status
    1. Sexually active males or females of childbearing potential who are not
    practicing two different methods of birth control during the study and for
    90 or 30 days respectively after the last dose of study medication or who
    will not remain abstinent during the study and for 90 or 30 days
    respectively after the last dose. (*)
    2. Females who are breast-feeding and/or who have a positive
    pregnancy test result prior to receiving study drug.
    Target Disease
    3. Subjects with a current need for involuntary commitment or who have
    been hospitalized <= 28 days of the Baseline Visit for the current major
    depressive episode.
    4. Subjects with a current Axis I (DSM-IV-TR) diagnosis of any of the
    disorders listed in the protocol (*)
    5. Subjects with a clinically significant current Axis II (DSM-IV-TR)
    diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or
    histrionic personality disorder.
    6. Subjects experiencing hallucinations, delusions or any psychotic
    symptomatology in the current depressive episode.
    Medical History and Concurrent Diseases
    7. Subjects with a significant risk of committing suicide based on history,
    investigator's judgement, and/or evaluation based on the C-SSRS.
    8. Subjects who have met DSM-IV-TR criteria for substance abuse in the
    past 6 months (prior to the Baseline Visit) and/or dependence up to and
    including the past 12 months (prior to Baseline Visit), including alcohol
    and benzodiazepines, but excluding caffeine and nicotine. (*)
    9. Subjects with hypothyroidism or hyperthyroidism (unless condition
    has been stabilized with medications for at least 90 days prior to the
    Baseline Visit). (*)
    10. Subjects who currently have clinically significant neurological,
    hepatic, renal, metabolic, haematological, immunological,
    cardiovascular, pulmonary, or gastrointestinal disorders. (*)
    11. Subjects with insulin-dependant diabetes mellitus (IDDM) are
    excluded. Subjects with non-IDDM may be eligible for the study if their
    condition is stable as determined by satisfying ALL of the criteria in
    protocol. (*)
    12. Subjects with epilepsy or significant history of seizure disorders,
    except a single childhood febrile seizure, posttraumatic, etc. An alcohol
    withdrawal seizure up to and including 24 months of the Baseline Visit is
    exclusionary.
    Physical and Laboratory Results
    13. Subjects with two positive drug screens for cocaine or other drugs of
    abuse (excluding stimulants and other prescribed medications and
    marijuana) (*)
    14. The following laboratory test are exclusionary: Platelets =<
    75,000/mm3; Hemoglobin =< 9 g/dL; Neutrophils, absolute =<
    1000/mm3; AST > 3x upper limit of normal as defined by the central
    laboratory; ALT > 3x upper limit of normal as defined by the central
    laboratory; Creatinine >= 2 mg/dL; (*)
    Prohibited Therapies or Medications
    15. Subjects who would be likely to require prohibited prior or
    concomitant therapy during the trial (*)
    16. Anticipated need for diphenylhydramine or hydroxyzine during the
    study and other antihistamines for the treatment of agitation, anxiety or
    insomnia.
    Allergies and Adverse Drug Reactions
    17. History of allergy or hypersensitivity to aripiprazole or escitalopram.
    18. Subjects with a history of neuroleptic malignant syndrome or serotonin syndrome.
    Other
    19. Prisoners or subjects who are compulsorily detained (involuntarily
    incarcerated) for treatment of either a psychiatric or physical (eg.
    infectious disease) illness must not be enrolled into this study.
    20. Any subject who, in the opinion of the investigator, should not
    participate in the study.
    Note: Subjects who do not qualify for Protocol 31-08-257 at the last visit
    of Protocol 31-08-255, 31-08-256, 31-08-263 may not be rescreened.
    * please see protocol for further information
    Actividad sexual y capacidad de reproducción
    1. Hombres sexualmente activos que no utilicen dos métodos anticonceptivos diferentes durante el estudio y 90 días después de recibir la última dosis del medicamento del estudio o que no practiquen la abstinencia sexual durante el estudio y 90 días después de recibir la última dosis, o mujeres sexualmente activas en edad de procrear que no utilicen dos métodos anticonceptivos diferentes durante el estudio y 30 días después de recibir la última dosis del medicamento del estudio o que no practiquen la abstinencia durante el estudio y 30 días después de recibir la última dosis. (*)
    Enfermedad objetivo
    3. Pacientes que necesiten actualmente estar recluidos involuntariamente o que hayan sido hospitalizados hasta 28 días antes de la visita basal debido al episodio de depresión actual. 4.Pacientes con un diagnóstico actual de eje I (DSM-IV-TR) descritos en el protocolo (*). 5. Pacientes con un diagnóstico actual clínicamente importante de Eje II (DSM-IV-TR) de trastorno de personalidad límite, antisocial, paranoide, esquizoide, esquizotípico o histriónico. 6. Pacientes que hayan experimentado alucinaciones, delirios o cualquier sintomatología psicótica durante el episodio de depresión actual.
    Antecedentes clínicos y enfermedades simultáneas
    7.Pacientes con un riesgo importante de suicidarse, según sus antecedentes, el criterio del investigador o la evaluación basada en la C-SSRS. 8.Pacientes que reúnan los criterios del DSM-IV-TR para toxicomanía en los últimos 6 meses (antes de la visita basal) o dependencia en los últimos 12 meses (antes de la visita basal), incluyendo alcohol y benzodiacepinas, pero no cafeína y nicotina (*) 9. Pacientes con hipo o hipertiroidismo (a menos que la afección se haya estabilizado con medicamentos durante al menos 90 días antes de la visita basal) (*) 10.Pacientes que presenten actualmente trastornos neurológicos, hepáticos, renales, metabólicos, hematológicos, inmunitarios, cardiovasculares, pulmonares o gastrointestinales clínicamente importantes (*) 11. Los pacientes con diabetes mellitus insulinodependiente (IDDM) serán excluidos. Los pacientes con diabetes mellitus no insulinodependiente pueden ser aptos para el estudio si su afección es estable, lo que debe determinarse por el cumplimiento de TODOS los criterios descritos en el protocolo (*) 12. Pacientes con epilepsia o antecedentes importantes de trastornos convulsivos, excepto una convulsión febril aislada en la infancia, postraumática, etc. Una convulsión por abstinencia del alcohol en los 24 meses anteriores a la visita basal es causa de exclusión.
    Resultados físicos y de laboratorio
    13. Pacientes con resultados positivos en dos determinaciones de drogas para cocaína u otras drogas (se excluyen los estimulantes, otros medicamentos recetados y la marihuana) (*) 14. Los siguientes resultados de análisis de laboratorio son factores de exclusión: 1) Plaquetas =<75.000/mm3; 2) Hemoglobina =<9 g/dl; 3) Neutrófilos, recuento absoluto =<1.000/mm3 4) AST superior a tres veces el límite superior de lo normal definido por el laboratorio central; 5) ALT superior a tres veces el límite superior de lo normal definido por el laboratorio central; 6) Creatinina >=2 mg/dl (*) Tratamientos o medicamentos prohibidos. 15. Pacientes que probablemente requerirán durante el ensayo tratamientos prohibidos anteriores o concomitantes (consulte la sección 4.1). 16. Previsión de la necesidad de usar difenhidramina o hidroxicina y otros antihistamínicos durante el estudio para tratar la agitación, la ansiedad o el insomnio.
    Alergias y reacciones adversas a medicamentos
    17. Antecedentes de alergia o hipersensibilidad al aripiprazol o al escitalopram. 18. Pacientes con antecedentes de síndrome neuroléptico maligno o de síndrome serotonínico.
    Otros
    19. Los prisioneros o pacientes que se encuentren confinados de forma obligatoria (encarcelados involuntariamente) para el tratamiento de una enfermedad psiquiátrica o física (p. ej., una enfermedad infecciosa) no deben incluirse en este estudio.
    20. Cualquier paciente que, en opinión del investigador, no deba participar en el estudio.
    Nota: Los pacientes que no reúnan los requisitos para el protocolo 31-08-257 en la última visita de los protocolos 31-08-255, 31-08-256 o 31-08-263 no podrán ser sometidos a una nueva selección.
    (*) para mas detalles consulte el protocolo del estudio
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome variable of safety will be the frequency and severity of AEs, including serious AEs (SAEs) and discontinuations from the study due to AEs.
    El criterio de valoración principal de seguridad será a la frecuencia y gravedad de los AA, incluyendo los AA graves (AAG) y los abandonos del estudio debidos a AA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Refer to E.5.1
    Ver E.5.1
    E.5.2Secondary end point(s)
    Key secondary efficacy variables will include the mean Clinical Global Impression - Severity of Illness Scale (CGI-S) score, and the mean Patient Global Impression of Severity (PGI-S) score at baseline and at each time point.
    In addition to AEs, safety variables examined in this study will include physical examinations, vital signs, body weight, body mass index (BMI), clinical laboratory tests (including, but not limited to, prolactin and hemoglobin A1c),
    electrocardiograms (ECGs), the Abnormal Involuntary Movement Scale (AIMS), the Simpson Angus Scale (SAS), the Barnes Akathisia Rating Scale (BARS), the Columbia-Suicide Severity Rating Scale (C-SSRS), and the Massachusetts General Hospital Sexual
    Functioning Inventory (MGH SFI).
    Outcome variables will be evaluated for the mean Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) scores, the mean Sheehan Disability Scale (SDS) score, and the Massachusetts General
    Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) score.
    Responses to the Resource Utilization Form will be summarized appropriately to explore the impact of treatment on health care resources.
    Las variables secundarias de eficacia importantes incluirán la puntuación media de la Impresión Clínica Global: escala de gravedad de la enfermedad (CGI-S) y la puntuación media de la Impresión global de gravedad del paciente (PGI-S) en la visita basal y en cada momento del estudio.
    Además de los EA, las variables de seguridad que se examinarán en este estudio incluirán las exploraciones físicas, constantes vitales, peso corporal, índice de masa corporal (IMC), análisis de laboratorio clínico (entre otros, prolactina y hemoglobina A1c), electrocardiogramas (ECG), la escala de movimientos anormales involuntarios (Abnormal Involuntary Movement Scale, AIMS), la escala de Simpson-Angus (Simpson Angus Scale, SAS), la escala de puntuación de la acatisia de Barnes (Barnes Akathisia Rating Scale, BARS), la Escala de puntuación de la intensidad de la intención suicida de Columbia (Columbia-Suicide Severity Rating Scale, C-SSRS) y el inventario de funcionamiento sexual del Massachusetts General Hospital (Massachusetts General Hospital Sexual Functioning Questionnaire, MGH SFI).
    Los criterios de valoración se evaluarán mediante las puntuaciones medias del cuestionario de calidad de vida: satisfacción y placer ? formulario corto (Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q-SF), de la escala de discapacidad de Sheehan (Sheehan Disability Scale, SDS) y del cuestionario de funcionamiento cognoscitivo y físico (Cognitive and Physical Functioning Questionnaire, CPFQ) del Massachusetts General Hospital. Las respuestas al formulario de utilización de recursos se resumirán adecuadamente para explorar la influencia del tratamiento sobre los recursos sanitarios.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Multiple timepoints (refer to Table 3.6.1 in the protocol for details)
    En momentos múltiples (para más detalle, véase en el protocolo, la tabla 3.6.1)
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other 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 EEA84
    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
    Australia
    Bulgaria
    Canada
    Croatia
    Estonia
    Finland
    France
    Germany
    Hungary
    India
    Italy
    Korea, Republic of
    Malaysia
    Mexico
    Philippines
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Sweden
    Taiwan
    Ukraine
    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
    Provided in protocol
    En el protocolo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1500
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 600
    F.4.2.2In the whole clinical trial 1500
    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)
    Normal standard of care
    Tratamiento estándar
    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 Decision2011-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2011-07-12
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