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    Summary
    EudraCT Number:2015-003503-39
    Sponsor's Protocol Code Number:ABR54654
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-06
    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 ConcernedGermany - BfArM
    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
    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
    A.3.2Name or abbreviated title of the trial where available
    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 number003188755 0695
    B.5.6E-mailI.E.Slot-3@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 INNFish oil 33/22 TG
    D.3.9.3Other descriptive nameOMEGA-3 FATTY ACIDS
    D.3.9.4EV Substance CodeSUB32453
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOCOPHEROLS MIXED
    D.3.9.1CAS number 8000025-00-5
    D.3.9.3Other descriptive nameTOCOPHEROLS MIXED
    D.3.9.4EV Substance CodeSUB15583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    E.1.1.1Medical condition in easily understood language
    Adolescents who are at risk for developing psychosis.
    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, as determined through the CAARMS, or when a subject exceeds the maximally allowed dose of antipsychotics during the study (i.e. equivalent of a total haloperidol use of 10 mg within two months) over a period of 2 years.
    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. Blood levels of bioactive lipids - comparison between the two treatment arms
    7. (epi)genetic markers - comparison between the two treatment arms
    8. Immune parameters - comparison between the two treamtent arms
    9. Assess the value of MRI and blood parameters as predictive measures for clinical response
    10. Cross-sectional and longitudinal comparisons of study parameters - comparsion between UHR subjects and healthy controls.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 13 - 20 (inclusive)
    •Written informed consent of the subject. For individuals below the age of legal capacity 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.
    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.
    • Pregnancy.
    •Allergy with sensitisation to coconut oil, fish oil other components of the IMP
    •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
    •Intake of an antipsychotic or mood-stabilising agent in the two weeks prior to study inclusion, except for situations as described in Protocol Version 3.7-GER, dated December 23th 2021 section 5.2
    •Intake of an antipsychotic agent equivalent to a total haloperidol use of >50 mg in the six months prior to study inclusion, except for situations as described in Protocol Version 3.7-GER, dated December 23th 2021 section 5.2
    •A first-degree relative (i.e. parents, offspring or siblings) participating in this study
    •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.
    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, or when a subject exceeds the maximally allowed dose of antipsychotics during the study (i.e. equivalent of a total haloperidol use of 10 mg within two months, except for situations as described in Protocol Version 3.7-GER, dated December 23th 2021 section 5.2).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The endpoint will evaluated at each study visit.
    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. Blood levels 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. Immune parameters
    [Time Frame: 2 years] [Safety Issue: No]
    Comparison between the two treatment arms

    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
    Comparison between the two treatment arms

    10. A subset of study parameters, including symptomatology, cognitive function and MRI
    [Time Frame: 2 years] [Safety Issue: No]
    Cross-sectional and longitudinal comparisons of study parameters
    Comparison between UHR subjects and healthy controls
    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.
    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
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Israel
    Austria
    Netherlands
    Spain
    Switzerland
    Germany
    Italy
    Norway
    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 determined through the CAARMS, or when a subject exceeds the maximally allowed dose of antipsychotics during the study (i.e. equivalent of a total haloperidol use of 10 mg within two months), over a period of 2 years. 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.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    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 2016-10-06. 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). The 110 healthy controls will have a similar age distribution but are not included in the numbers entered above as they will not undergo treatment.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    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
    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 Decision2018-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-02-01
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