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    Summary
    EudraCT Number:2008-005004-13
    Sponsor's Protocol Code Number:NEURAPRO-E FINAL Protocol
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-10-06
    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 ConcernedAustria - BASG
    A.2EudraCT number2008-005004-13
    A.3Full title of the trial
    Add-on Therapie mit Omega-3 Fettsäuren bei Jugendlichen mit hohem Risiko
    für Schizophrenie und andere psychotische Störungen: eine Multizentren-
    Replikationsstudie
    Omega-3 Fatty Acids for Symptomatic Patients at Ultra-High Risk for Early Progression to Schizophrenia and Other Psychotic Disorders: A Multicentre Replication
    Study
    A.3.2Name or abbreviated title of the trial where available
    Omega-3 fatty acids for indicated prevention of psychotic disorders
    A.4.1Sponsor's protocol code numberNEURAPRO-E FINAL Protocol
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOrygen Research Centre
    B.1.3.4CountryAustralia
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name EPAX 6000 TG
    D.2.1.1.2Name of the Marketing Authorisation holderEPAX AS
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 (EPA, DHA)
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 8000055007
    D.3.9.3Other descriptive nameOMEGA-3 MARINE TRIGLYCERIDES
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.4
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the 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
    In view of recent data and after a careful review of potentially neuroprotective treatment options in early psychotic illness, we have decided to replicate the findings of a randomized controlled trial of Amminger et al. (ClinicalTrials.gov, number NCT00396643) studying the efficacy of omega-3 fatty acids (EPA/DHA) in young patients at ultra-high-risk for psychosis preventing the onset of schizophrenia or other psychotic disorders.
    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
    1) Are in addition to standard “state-of-the-art” treatment, omega-3 fatty acids EPA/DHA significantly more effective than placebo in reducing the rate of transition to a first episode of psychosis in an ‘at-risk’ cohort over a 12-month period?

    2) Does the use of EPA/DHA result in a higher percentage of responders (i.e., symptomatic and functional improvement) compared to placebo?
    E.2.2Secondary objectives of the trial
    Are to determine:
    1) If any clinical or demographic risk factors predict response to EPA/DHA treatment in the ‘at-risk’ group?

    2) If lipid metabolism characteristics which have been observed in people with schizophrenia (e.g., reduced AA, increased iPLA2 activity) significantly more prevalent in those individuals who make a transition to psychosis?

    3) If pre/post intervention changes in red blood cell fatty acids related to symptomatic and/or functional improvement?

    4) If the use of EPA/DHA significantly improve cognitive functions (frontal cortex: executive function, attention; hippocampus: working memory) compared to placebo?
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Indicated Prevention With Omega-3 Fatty Acids in Adolescents With 'At-Risk-Mental-State' for Psychosis:

    Neuroprotective treatment options in early psychotic illness; A randomized controlled trial of Amminger et al. (ClinicalTrials.gov, number NCT00396643) studying the efficacy of omega-3 fatty acids (EPA/DHA) in young patients at ultra-high-risk for psychosis preventing the onset of schizophrenia or other psychotic disorders.
    E.3Principal inclusion criteria
    Inclusion criteria

    A. General inclusion criteria:
    i. Ability to give informed consent
    ii. Age 13-25 years

    B. Membership of one of the following three ‘at-risk’ groups:
    i. Attenuated Psychotic Symptoms Group (APS) Individuals with subthreshold (intensity or frequency) positive psychotic symptoms. The symptoms must have been present during the past year and be associated with a significant reduction in functioning.
    ii. Brief Limited Intermittent Psychotic Symptoms Group (BLIPS) Individuals with a recent history of frank psychotic symptoms that resolved spontaneously (without antipsychotic medication) within one week. The symptoms must have been present during the past year and be associated with a significant reduction in functioning.
    iii. Trait and State Risk Factor Group Individuals with a combination of a trait risk factor (such as schizotypal personality disorder or a family history of psychotic disorder in a first degree relative) and a significant deterioration in mental state and/or functioning for at least one month at the time of intake. Operationalized intake criteria based on the Comprehensive Assessment of At-Risk Mental State (CAARMS; Yung et al, 1998) are presented in Table 1.

    Table 1: Operationalized intake criteria
    Group 1: Attenuated Psychotic Symptoms Group
    1a) Subthreshold intensity:
    Intensity: Severity Scale Score of 3-5 on Disorders of Thought Content subscale, 3-4 on Perceptual Abnormalities subscale and/or 4-5 on Disorganised Speech subscales of the CAARMS
    Frequency: Frequency Scale Score of 3-6 on Disorders of Thought Content, Perceptual Abnormalities and/or Disorganised Speech subscales of the CAARMS
    Duration : symptoms present for at least one week
    Recency: symptoms present in past year
    Impact: SOFAS score currently and for the last month a at least 30% below previous level of functioning .
    1b) Subthreshold frequency:
    Intensity: Severity Scale Score of 6 on Disorders of Thought Content subscale, 5-6 on Perceptual Abnormalities subscale and/or 6 on Disorganised Speech subscales of the CAARMS
    Frequency: Frequency Scale Score of 3 on Disorders of Thought Content, Perceptual Abnormalities and/or Disorganised Speech subscales of the CAARMS
    Duration: symptoms present for at least one week
    Recency: symptoms present in past year
    Impact: SOFAS score currently and for the last month a at least 30% below previous level of functioning .

    Group 2: BLIPS Group
    Intensity: Severity Scale Score of 6 on Disorders of Thought Content subscale, 5 or 6 on Perceptual Abnormalities subscale and/or 6 on Disorganised Speech subscales of the CAARMS
    Frequency: Frequency Scale Score of 4-6 on Disorders of Thought Content, Perceptual Abnormalities and/or Disorganised Speech subscales
    Duration: Symptoms present for less than one week and spontaneously remit.
    Recency: symptoms present in past year
    Impact: SOFAS score currently and for the last month a at least 30% below previous level of functioning

    Group 3: Vulnerability Group
    Family history of psychosis in first degree relative OR Schizotypal Personality Disorder (as defined by DSM IV) in identified patient
    Recency: Change in functioning occurred within last year
    Impact: SOFAS score currently and for the last month a at least 30% below previous level of functioning
    E.4Principal exclusion criteria
    Exclusion criteria include:
    i. Past history of a treated or untreated psychotic episode of one week’s duration or
    longer
    ii. Organic brain disease, e.g. epilepsy, inflammatory brain disease
    iii. Abnormal coagulation profile parameters or thyroid function test results >10% above or below the limits of the normal range.
    iv. Any physical illness with psychotropic effect, if not stabilized
    v. Current treatment with lithium, methyl phenidate or ketamine, or recreational use of
    ketamine.
    vi. Past neuroleptic exposure equivalent to a total lifetime haloperidol dose of >50 mg.
    [Refer to Appendix IV of the protocol for a list of equivalent doses for other neuroleptic agents.]
    vii. Diagnosis of a serious developmental disorder, e.g. Asperger's syndrome
    viii. Premorbid IQ < 70 and a documented history of developmental delay or intellectual
    disability
    ix. Current aggression/dangerous behaviour (CAARMS 5.4 severity score 6)
    x. Current suicidality/self harm (CAARMS 7.3 severity score 6)
    xi. Current pregnancy
    xii. Current attenuated symptoms that are entirely explained by acute intoxication (e.g., current attenuated symptoms entirely explained by LSD use).
    xiii. > than 4 weeks of regular omega-3 supplementation (>2 capsules standard strength providing >600 mg combined EPA/DHA) within the last 6 months.
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point is a transition to a first episode of psychosis. Transition is operationally defined via rating scales, as in previous studies, as one of:
    1. Abnormal thoughts held with delusional intensity occurring every day for one week or longer
    2. True hallucinations in any modality occurring every day for one week or longer
    3. Formal thought disorder to the degree of incoherence and/or loose associations occurring every day for one week or longer
    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 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 Yes
    E.6.13.1Other scope of the trial description
    indicated prevention
    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 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 No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months0
    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 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.1.1.1In 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.1.2Adults (18-64 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 180
    F.4.2.2In the whole clinical trial 320
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-10-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-04
    P. End of Trial
    P.End of Trial StatusOngoing
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