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    Summary
    EudraCT Number:2016-004970-16
    Sponsor's Protocol Code Number:CS15-033
    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:2017-04-14
    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 number2016-004970-16
    A.3Full title of the trial
    Imaging the functional and molecular impact of poly-unsaturated fatty acids on dopamine-dependent cognitive functions: a combined [11C]-(+)-PHNO PET/MRI study at different stages of cognitive impairment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A neuro-imaging study on the role of fatty acids in cognition
    A.3.2Name or abbreviated title of the trial where available
    Fatty acids in cognition
    A.4.1Sponsor's protocol code numberCS15-033
    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 SponsorMedizinische Universität Wien
    B.1.3.4CountryAustria
    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 supportMedizinische Universität Wien
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedizinische Universität Wien
    B.5.2Functional name of contact pointDept. of Psychiatry & Psychotherapy
    B.5.3 Address:
    B.5.3.1Street AddressWaehringer Guertel 18-20
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1090
    B.5.3.4CountryAustria
    B.5.4Telephone number004314040035680
    B.5.5Fax number004314040035990
    B.5.6E-mailbiol-psy@meduniwien.ac.at
    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 1000 mg Kapseln
    D.2.1.1.2Name of the Marketing Authorisation holderGoerlich Pharma
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameEPAX 6000 TG 1000 mg Kapseln
    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 INNDOCOSAHEXAENOIC ACID
    D.3.9.1CAS number 6217-54-5
    D.3.9.4EV Substance CodeSUB121918
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEICOSAPENTAENOIC ACID
    D.3.9.1CAS number 25378-27-2
    D.3.9.4EV Substance CodeSUB13664MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 typeEPAX is a dietary supplement containing crude fish oil suitable for human consumption (Regulation EC No. 853/2004).
    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
    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
    This study will assess the effects of poly-unsaturated fatty acids on working memory (measured using an n-back test) in healthy volunteers, in subjects who are at high risk for developing a psychotic disorder and in patients with first-episode schizophrenia.
    E.1.1.1Medical condition in easily understood language
    This study will assess the effects of fatty acids on working memory in healthy volunteers, in subjects at high risk for developing psychosis and in patients with first-episode schizophrenia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10039628
    E.1.2Term Schizophrenia and other psychotic disorders
    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 study the effects of dietary supplementation with poly-unsaturated fatty acids(PUFAs) and of amphetamine-induced dopamine-release on dopamine-dependent, working-memory related brain networks.
    To develop a [11C]-(+)-PHNO positron-emission tomography (PET) paradigm for the 3T Siemens mMRBiograph system for studying amphetamine-induced dopamine release in a single scanning session.
    To develop an in-vitro model of altered dopamine function in schizophrenia by transorming fibroblasts derived from study participants viy skin punch biopsy into dopaminergic neuron-like cells.
    To study the impact of phospholipase-2 (PLA2) stimulation by melittin and PUFAs on the dopamine transporter in HEK 293 cells and later in fibroblast-derived neuron-like cells; initiation of molecular dynamics (MD) simulations on the impact of dopamine transporter conformations.
    E.2.2Secondary objectives of the trial
    To relate the magnitude of amphetamine-induced dopamine-release measured with [11C]-(+)-PHNO PET on specific functional brain networks (for example default-mode network) using functional magnetic resonance imaging (fMRI) and connectivity analyses.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All subjects
    • age 18-65
    • good general health
    • absence of relevant abnormalities in laboratory screening, ECG or vital signs
    • no regular use of drugs of abuse or alcohol based on history and urine drug screen.
    Healthy subjects
    • Absence of psychiatric disorders according to M.I.N.I.
    ARMS subjects
    • CAARMS above ARMS threshold
    Patients with schizophrenia
    • diagnosis of SCZ or other non-affective psychotic disorder according to DSM-5
    • minimum Positive and Negative Syndrome Scale (PANSS) total score of 55 (> 3 on at least two or >4 on one psychosis item
    • ability to give informed consent
    E.4Principal exclusion criteria
    All subjects
    • severe or unstable medical or neurologic disorders or clinically significant abnormality on screening laboratory studies
    • clinically relevant abnormalities in the electro-cardiogram (ECG)
    • history of myocardial infarction or angina pectoris, arterial hypertension or paroxysmal hypertensive states
    • established diagnosis of advanced arteriosclerosis or hyperthyroidism
    • current substance use disorder (except nicotine)
    • lifetime use of stimulants exceeding 5 or more exposures
    • pregnancy or breast feeding
    • known hypersensitivity to sympathomimetics
    • history of severe head trauma
    • positive urine drug screen
    • presence of MRI exclusion criteria
    • if participation in this study would exceed annual radiation dose limits (30mSv)
    • known allergy to any ingredients of the PUFA or placebo capsules
    • Patients with schizophrenia
    • previous oral antipsychotic treatment for more than 2 weeks, or antipsychotics within two weeks prior to PET scan; previous treatment with antipsychotic depot preparation.
    • ARMS subjects
    • psychotic disorder according to DSM-5 (CAARMS above psychosis threshold)
    E.5 End points
    E.5.1Primary end point(s)
    1) To measure an increased amphetamine-induced reduction in binding of the dopamine D2/3 agonist radioligand [11C]-(+)-PHNO in patients with schizophrenia and part of the at risk mental state (ARMS) collective as compared to healthy control subjects.
    2) To measure a significant amphetamine-induced reduction in working memory performance assessed using an n-back paradigm in subjects with presumed high baseline dopamine activity (patients with schizophrenia and part of the ARMS collective).
    3) To measure a normalization of amphetamine-induced reductions in [11C]-(+)-PHNO binding in ARMS subjects with increased baseline response after PUFA intakeas compared to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) and 2) at baseline (i.e. before PUFA or placebo intake)
    3) after intake of PUFA (EPAX 6000) capsules for 8-12 weeks and after intake of placebo for 8-12 weeks
    E.5.2Secondary end point(s)
    1) To measure alterations in dopamine-related brain networks (at rest and while performing an n-back test) in patients with schizophrenia or ARMS as compared to healthy control subjects using functional magnetic resonance imaging
    2) To relate amphetamine-induced changes in these networks to amphetamine-induced dopamine release as measured by reductions in [11C]-(+)-PHNO binding
    3) To image changes in the response of dopamine-related brain networks to amphetamine after PUFA (EPAX 6000) supplementation in healthy and ARMS subjects
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) and 2) at baseline (i.e. before PUFA or placebo intake)
    3) after intake of PUFA (EPAX 6000) capsules for 8-12 weeks and after intake of placebo for 8-12 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety 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 Yes
    E.6.13.1Other scope of the trial description
    To study the role of dopamine in psychosis and cognitive function; to study a possible impact of PUFA supplementation on dopamine-related cognitive networks
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 66
    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 2017-04-14. Yes
    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 state66
    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)
    For patients only: treatment as usual according to clinical standards at the Department of Psychiatry and Psychotherapy, Medical University of Vienna
    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 Decision2017-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-27
    P. End of Trial
    P.End of Trial StatusOngoing
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