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    Summary
    EudraCT Number:2015-003503-39
    Sponsor's Protocol Code Number:ABR54654
    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:2016-09-09
    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 number2015-003503-39
    A.3Full title of the trial
    Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe
    Ensayo controlado con placebo en sujetos con alto riesgo para la psicosis comparado con ácidos grasos omega-3 en Europa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in subjects at risk for psychosis, treated with fish oil or placebo, in Europe
    Ensayo en sujetos con alto riesgo para la psicosis tratados con ácidos grasos omega-3 o placebo, en Europa
    A.3.2Name or abbreviated title of the trial where available
    PURPOSE
    PURPOSE
    A.4.1Sponsor's protocol code numberABR54654
    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 SponsorUniversity Medical Center Utrecht
    B.1.3.4CountryNetherlands
    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 supportStanley Medical Research Institute
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Utrecht
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584 CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00318875 563 69
    B.5.6E-mailm.bossong@umcutrecht.nl
    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 nameOmega-3 fatty acids
    D.3.4Pharmaceutical form Capsule, soft
    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 INNOMEGA-3 FATTY ACIDS
    D.3.9.3Other descriptive nameOMEGA-3 FATTY ACIDS
    D.3.9.4EV Substance CodeSUB32453
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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 Yes
    D.3.11.13.1Other medicinal product typeOmega-3 is a food supplement. The capsules used in this trial have been studied before. The exact composition (ratio DHA-EPA) slightly differs from the commercially available omega-3 fatty acids.
    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, soft
    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
    Individuals at Ultra High Risk for Psychosis
    Sujetos con alto riesgo para la psicosis
    E.1.1.1Medical condition in easily understood language
    Adolescents who are at risk for developing psychosis.
    Adolescentes con alto riesgo para la psicosis
    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
    To compare transition rates to psychosis during 2 years of follow-up between the omega-3 fatty acids arm and the placebo arm in adolescent subjects who are at risk for developing psychosis. Starting point is the first administration of study medication at the end of visit 2. Endpoint is the moment that a UHR subject makes a transition to psychosis according to the CAARMS criteria, over a period of 2 years.
    Comparar la tasa de transición a trastorno psicótico durante 2 años de seguimiento entre individuos que están en riesgo a desarrollar una psicosis (SRP) que toman ácidos grasos omega-3 versus los individuos en riesgo de psicosis que toman placebo. El punto de inicio es la primera administración de la medicación del estudio al final de la visita 2. La variable es el momento en el cual los sujetos en riesgo a desarrollar una psicosis realizan la transición a psicosis de acuerdo a los criterios de la escala CAARMS
    E.2.2Secondary objectives of the trial
    1. Discontinuation rates - comparison between the two arms
    2. Tolerability - comparison between the two treatment arms
    3. Symptomatology - comparison between the two treatment arms
    4. Psychosocial and cognitive function - comparison between the two treatment arms
    5. Quality of life - comparison between the two treatment arms
    6. Bloodlevels of bioactive lipids - comparison between the two treatment arms
    7. (epi)genetic markers - comparison between the two treatment arms
    8. Brain structure and function - comparison between the two treatment arms as measured wit Magnetic Resonance Imaging (MRI)
    9. Assess the value of MRI and blood parameters as predictive measures for clinical response.
    1.Tasa de discontinuidad- Comparación entre las 2 ramas.
    2.Tolerabilidad- Comparación entre las 2 ramas.
    3.Sintomatología- Comparación entre las 2 ramas.
    4.Funcionamiento psicosocial y funcionamiento cognitivo- Comparación entre las 2 ramas.
    5.Calidad de vida- Comparación entre las 2 ramas.
    6.Niveles de sangre de lípidos bioactivos- Comparación entre las 2 ramas.
    7.Marcadores epigenéticos- Comparación entre las 2 ramas.
    8.Estructura y la función cerebral: Comparación entre las 2 ramas y mesuradas mediante imágenes de resonancia magnética (IRM).
    9.Búsqueda de potenciales biomarcadores (IRM i parámetros en sangre) que puedan predecir la respuesta clínica de los sujetos en riesgo de psicosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Written informed consent of the subject. For individuals younger than 18 years of age the parents / legal representatives need to give consent, and the subject can provide assent (whether the latter is required depends on local laws and regulations).
    -UHR diagnosis as made using the Comprehensive Assessment of At-Risk Mental States (CAARMS) (Yung et al., 2005). Subjects have to meet one or more of the following criteria: (a) attenuated psychotic symptoms, (b) brief limited intermittent psychotic symptoms (a history of one or more episodes of frank psychotic symptoms that resolved spontaneously within 1 week in the past year), or (c) either the presence of schizotypal personality disorder or a family history of psychosis in a first-degree relative, all three together with a recent decline in function.
    -Que tengan el consentimiento informado firmado. Para los sujetos menores a 18 años deberán firmar el consentimiento informado sus padres o tutores legales. Los pacientes deberán firmar un asentimiento informado.
    -Que cumplan con los criterios definidos para el riesgo de psicosis evaluados mediante la entrevista Comprehensive Assessment of At-Risk Mental States (CAARMS, Yung et al 2005). Los sujetos tienen que cumplir uno o más de los siguientes criterios: (a) Síntomas psicóticos atenuados, (b) síntomas psicóticos breves e intermitentes, (c) presentar o bien un trastorno de personalidad esquizotipica o bien tener historia de psicosis en un familiar de primer grado, todos ellos acompañados por una reciente disminución en la funcionalidad.
    E.4Principal exclusion criteria
    •Any clinically significant medical condition that may influence the results of the trial or affect the ability to take part in a trial.
    •Laboratory screening values considered clinically relevant by a medical doctor for transaminases, thyroid hormones or coagulation parameters
    •Current or past DSM-IV diagnosis of psychosis, as measured with K-SADS-PL
    •Current treatment with an antipsychotic or mood-stabilising agent
    •Intake of an antipsychotic or mood-stabilising agent in the two weeks prior to study inclusion
    •Intake of an antipsychotic agent equivalent to a total haloperidol use of >50 mg in the six months prior to study inclusion
    •UHR diagnosis on the basis of attenuated psychotic symptoms that are entirely explained by acute intoxication
    •Current aggression or dangerous behaviour (PANSS G14 score 5 or above)
    •Current suicidality / self-harm (PANSS G6 score 7)
    •Current DSM-IV diagnosis of alcohol or substance dependence as measured with K-SADS-PL
    •Any current or previous neurological disorder, including epilepsy
    •History of head injury resulting in unconsciousness lasting at least 1 hour
    •IQ < 70
    •More than 4 weeks of regular omega-3 supplementation (>2 daily capsules standard strength providing >600 mg combined EPA/DHA) within the last 6 months.
    -Cualquier condición médica que pueda influenciar en los resultados del ensayo clínico.
    -Valores del cribaje de laboratorio considerados clínicamente significantes por un doctor para transaminasas, hormonas tiroideas o parámetros de coagulación.
    -Poseer algún diagnostico presente o pasado de psicosis, según criterios DSM-IV.
    -Estar en tratamiento antipsicótico o un estabilizador del estado de ánimo.
    -Toma de antipsicóticos o estabilizadores del estado de ánimo en las dos semanas anteriores al inicio del estudio.
    -Haber tomado antipsicóticos equivalente a una dosis de haloperidos mayor a 50 mg en los seis meses previos al estudio.
    -Que los síntomas SRP solo aparezcan en el contexto de una intoxicación aguda.
    -Comportamiento agresivo o peligroso (puntuación de 5 o más en el ítem G14 de la PANSS)
    -Conductas suicidas o autolesiones (ítem G6 de la PANSS puntuación de 7)
    -Diagnostico actual de dependencia de alcohol o substancias medido con la entrevista K-SADS-PL
    -Cualquier diagnóstico actual o previo de trastorno neurológico, incluyendo epilepsia
    -Historia de traumatismo craneoencefálico con pérdida de conciencia de como mínimo 1 hora.
    -CI<70
    -Más de 4 semanas de toma de suplemento regular con omega-3 (>2 cápsulas diarias que proporcionen una combinación de >600 mg de EPA/DHA).
    E.5 End points
    E.5.1Primary end point(s)
    The moment that a UHR subject makes a transition to psychosis according to the CAARMS criteria.
    Momento en el cual los sujetos en riesgo a desarrollar una psicosis realizan la transición a psicosis de acuerdo a los criterios de la escala CAARMS
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endpoint will evaluated at each study visit.
    La variable será medida en cada visita del estudio
    E.5.2Secondary end point(s)
    1. Discontinuation rate
    [Time Frame: 2 years] [Safety Issue: No]
    Comparison between the two arms

    2. Tolerability
    [Time Frame: 2 years] [Safety Issue: No]
    Comparison between the two treatment arms

    3. Symptomatology
    [Time Frame: 2 years] [Safety Issue: No]
    Comparison between the two treatment arms

    4. Psychosocial and cognitive function
    [Time Frame: 2 years] [Safety Issue: No]
    Comparison between the two treatment arms

    5. Quality of life
    [Time Frame: 2 years] [Safety Issue: No]
    Comparison between the two treatment arms

    6. Bloodlevels of bioactive lipids
    [Time Frame: 2 years] [Safety Issue: No]
    Comparison between the two treatment arms

    7. (epi)genetic markers
    [Time Frame: 2 years] [Safety Issue: No]
    Comparison between the two treatment arms

    8. Brain structure and function
    [Time Frame: 2 years] [Safety Issue: No]
    Comparison between the two treatment arms as measured with Magnetic Resonance Imaging (MRI)

    9. MRI and blood parameters
    [Time Frame: 2 years] [Safety Issue: No]
    The ability of MRI and blood parameters to serve as potential biomarkers that may predict clinical response
    1. Tasa de discontinuidad
    (Periodo de tiempo: 2 años, Incidente de seguridad: No)
    Comparación entre las 2 ramas.
    2.Tolerabilidad
    (Periodo de tiempo: 2 años, Incidente de seguridad: No)
    Comparación entre las 2 ramas.
    3.Sintomatología
    (Periodo de tiempo: 2 años, Incidente de seguridad: No)
    Comparación entre las 2 ramas.
    4.Funcionamiento psicosocial y funcionamiento cognitivo
    (Periodo de tiempo: 2 años, Incidente de seguridad: No)
    Comparación entre las 2 ramas.
    5.Calidad de vida
    (Periodo de tiempo: 2 años, Incidente de seguridad: No)
    Comparación entre las 2 ramas.
    6.Niveles de sangre de lípidos bioactivos
    (Periodo de tiempo: 2 años, Incidente de seguridad: No)
    Comparación entre las 2 ramas.
    7.Marcadores epigenéticos
    (Periodo de tiempo: 2 años, Incidente de seguridad: No)
    Comparación entre las 2 ramas.
    8.Estructura y la función cerebral:
    (Periodo de tiempo: 2 años, Incidente de seguridad: No)
    Comparación entre las 2 ramas y mesuradas mediante imágenes de resonancia magnética (IRM).
    9. IRM y parámetros en sangre:
    (Periodo de tiempo: 2 años, Incidente de seguridad: No)
    Potenciales biomarcadores que pueden predecir la respuesta clínica de los sujetos en riesgo de psicosis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the study, the subject sample will be grouped into those who made the transition versus those who did not make the transition to psychosis. The secondary endpoints will be compared at each available timepoint between the 2 groups.
    Al final del estudio, la muestra objeto se agruparán en los que han hecho la transición en comparación con los que no hacen la transición a la psicosis. Los criterios de valoración secundarios se compararon en cada punto disponible entre los 2 grupos.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 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 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 Yes
    E.8.2.3.1Comparator description
    Controles sanos
    Healthy controls
    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 EEA16
    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
    Austria
    Germany
    Israel
    Italy
    Netherlands
    Norway
    Spain
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    For each subject, participating in the trial ends when a transition to psychosis is made, as confirmed through the CAARMS. This moment of transition can take place any time between shortly after the start of the trial up until the end of the 2-years follow-up period.
    La participación de cada sujeto finaliza cunado la transición ha psicosis se ha realizado según la escala CAARMS. Dicho momento de transición puede darse en cualquier momento desde el inicio del ensayo o final del mismo en los 2 años de seguimiento.
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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 Yes
    F.1.1Number of subjects for this age range: 160
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 160
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations 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 2016-09-09. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors are to be included in the treatment trial (n=220, about 70% is expected to be 13-18 years old). Additionally, 110 health controls will be included (similar age distribution)
    Se incluirán menores en el ensayo en la rama de tratamiento ( n=220 de los cuales el 70% se estiman menores de 13 a 18 años de edad). Adicionalmente serán incluidos 110 pacientes de control sanos (distribución de edades similar)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 190
    F.4.2.2In the whole clinical trial 220
    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)
    none
    Ninguno
    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 Decision2016-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-28
    P. End of Trial
    P.End of Trial StatusOngoing
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