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    Summary
    EudraCT Number:2015-004483-11
    Sponsor's Protocol Code Number:80-83600-98-40120
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-09-26
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2015-004483-11
    A.3Full title of the trial
    Raloxifene Augmentation in Patients with a Schizophrenia spectrum Disorder to reduce symptoms and improve cognition
    Raloxifeen augmentatie bij patiënten met een schizofreniespectrumstoornis voor vermindering van symptomen en verbetering van het denkvermogen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Raloxifene in patients with a schizophrenia spectrum disorder
    Raloxifeen bij patienten met een schizofreniespectrumstoornis
    A.3.2Name or abbreviated title of the trial where available
    RAPSODI (Raloxifene Augmentation in Patients with a Schizophrenia spectrum Disorder)
    A.4.1Sponsor's protocol code number80-83600-98-40120
    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 supportZonMw
    B.4.2CountryNetherlands
    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 pointJanna de Boer
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.4CountryNetherlands
    B.5.6E-mailj.n.deboer-18@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 Yes
    D.2.1.1.1Trade name raloxifene hydrochloride
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameRaloxifene hydrochloride
    D.3.2Product code RVG 114381
    D.3.4Pharmaceutical form Coated tablet
    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 INNRaloxifene hydrochloride
    D.3.9.1CAS number 82640-04-8
    D.3.9.3Other descriptive nameRALOXIFENE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB12568MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    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
    schizophrenia, schizoaffective, schizophreniform disorder or psychosis not otherwhise specified (DSM-IV 295.*)
    Schizofrenie, schizofreniforme stoornis, schizoaffectieve stoornis, psychose niet anderszins omschreven
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    Schizofrenie
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10039635
    E.1.2Term Schizophrenia schizoaffective
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10039648
    E.1.2Term Schizophreniform illness
    E.1.2System Organ Class 100000004873
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10039632
    E.1.2Term Schizophrenia NOS
    E.1.2System Organ Class 100000004873
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this trial is to investigate the beneficial effect of raloxifene as compared to placebo when given for twelve weeks in addition to antipsychotic medication. We expect to find lower symptom severity as measured with the Positive And Negative Symptom Scale (PANSS) over the course of twelve weeks.
    Het primaire doel van deze studie is het effect van raloxifene onderzoeken in vergelijking met placebo bij toediening gedurende twaalf weken naast antipsychotische medicatie. We verwachten een lagere ernst van de symptomen zoals gemeten met de Postive and Negative Symptom Scale (PANSS).
    E.2.2Secondary objectives of the trial
    Secondary objectives concern change in functional outcome (PSP), change in negative symptoms (BNSS), change in cognitive symptoms (BACS), change in severity of thought disorder (using the Thought And Language Disorder scale, TALD), change in health-related quality of life and quality adjusted life years (QALY) outcomes using the EQ-5D, change in cognitive control (Stroop Test), change in use of healthcare and non-healthcare resources, change in comorbid depression will be monitored using Beck’s Depression Inventory (BDI), change in productive language tested by analyzing speech recordings, change in psychophysiological parameters of basic information processing will be assessed through an electroencephalogram (EEG, i.e. N100 and P300). Hormone- and deoxyribonucleic acid (DNA)-profiles will be used to analyze the efficacy of raloxifene augmentation in different groups.
    Secundaire doelstellingen zijn verandering in functionele uitkomst (PSP), verandering in negatieve symptomen (BNSS), verandering in cognitie (BACS), verandering in formele denkstoornissen gemeten met de Thought And Language Disorder scale (TALD), verandering in gezondheidsgerelateerde kwaliteit van leven en de kwaliteit gecorrigeerde levensjaren (QALY) resultaten, verandering in het gebruik medische en niet-medische middelen, verandering in comorbide depressie met behulp van Beck's Depression Inventory (BDI), verandering in cognitieve controle gemeten d.m.v. een Stroop Test, verandering in productieve taal getest door het analyseren van spraakopnames, verandering in psychofysiologische parameters van basisinformatieverwerking d.m.v. een elektro-encefalogram (EEG). Hormoon- en DNA-profielen worden gebruikt om de effectiviteit van raloxifeenaugmentatie te bepalen in verschillende groepen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, schizoaffective disorder, or psychotic disorder NOS)
    - Capable of understanding the purpose and details of the study in order to provide written informed consent;
    - On a stable dose of antipsychotic medication for at least two weeks;
    - Age over 18 years.

    For female patients:
    - Female patients who are sexually active must be willing and capable to use a non-hormonal contraceptive (intrauterine device, cervical cap, condom, diaphragm) in case of sexual intercourse for the complete duration of the study;
    - Female patients with post coital uterine bleeding must have documented normal PAP smear and pelvic examination in the preceding five years.
    - Female patients between the age of 52 and 75 must have a normal documented mammogram.
    - Een DSM-IV-R diagnose: 295.x (schizofrenie, schizofreniforme stoornis, schizo-affectieve stoornis, of psychotische stoornis NOS)
    - In staat om het doel en de details van het onderzoek te begrijpen en om schriftelijk toestemming verlenen;
    - Op een stabiele dosis van antipsychotische medicatie voor ten minste twee weken;
    - Leeftijd meer dan 18 jaar.

    Voor vrouwelijke patiënten:
    - Vrouwelijke patiënten die seksueel actief zijn moeten bereid en in staat zijn om een niet-hormonale anticonceptie (spiraaltje, pessarium, condooms, diafragma) gebruiken in geval van geslachtsgemeenschap voor de volledige duur van de studie zijn;
    - Vrouwelijke patiënten met post-coïtale bloedingen moeten een gedocumenteerd normaal uitstrijkje en onderzoek van de pelvis hebben in de voorgaande vijf jaar.
    - Vrouwen tussen de 52 en 75 jaar moeten een normaal gedocumenteerd mammogram hebben.
    E.4Principal exclusion criteria
    - Pre-existing cardiovascular disease;
    - History of thrombo-embolic events;
    - Familial tendency to form blood clots (such as familial factor V Leiden);
    - Use of vitamin K antagonists;
    - Use of cholestyramine or other anion exchange resins;
    - Use of levothyroxine or other thyromimetics;
    - Hypertriglyceridemia (triglycerides > 3 times the upper limit of normal (ULN));
    - History of breast cancer;
    - Liver function or enzyme disorders (serum bilirubin, alkaline phosphatase (AF), gamma-glutamyl transpeptidase (γ - GT), aspartate aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 3 times the ULN as measured at baseline);
    - Severe kidney failure (eGFR <30 ml/min as measured at baseline)
    - Use of any form of estrogen, progestin or androgen as hormonal therapy, or antiandrogen including tibolone or use of phytoestrogen supplements as powder or tablet in the past three months.

    For female patients:
    - Pregnancy or breast feeding;
    - Reeds bestaande hart- en vaatziekten;
    - Geschiedenis van trombo-embolische voorvallen;
    - Familial neiging om bloedstolsels (zoals erfelijke factor V Leiden) te vormen;
    - Het gebruik van vitamine K-antagonisten;
    - Gebruik van colestyramine of andere anionenuitwisselingsharsen;
    - Gebruik van levothyroxine of andere thyreomimetica
    - Geschiedenis van hypertriglyceridemie (triglyceriden > 3 keer de bovengrens van normaal);
    - Geschiedenis van borstkanker;
    - Leverfunctiestoornissen of leverenzymstoornissen (serum bilirubine, alkalisch fosfatase (AF), gamma-glutamyl transpeptidase (γ - GT), aspartaat aminotransferase (ASAT) or alanine aminotransferase (ALAT) > 3 keer de bovengrens van normaal, zoals gemeten op baseline)
    - Ernstige nierinsufficiëntie (GFR <30 ml / min, zoals gemeten op baseline).
    - Het gebruik van een vorm van oestrogeen, progesteron of androgeen als hormoontherapie, of anti-androgeen waaronder tibolon of het gebruik van fyto-oestrogeen supplementen als poeder of tablet in de afgelopen drie maanden.

    Voor vrouwelijke patiënten:
    - Zwangerschap of borstvoeding;
    E.5 End points
    E.5.1Primary end point(s)
    Symptom severity as measured with the Positive And Negative Symptom Scale (PANSS)
    Ernst van de symptomen, zoals gemeten met de Positive and Negative Symptom Scale (PANSS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, after 6 and 12 weeks of treatment, 6 months follow-up after end of treatment.
    Baseline, na 6 en 12 weken behandeling en na 6 maanden follow-up na afloop van de behandeling.
    E.5.2Secondary end point(s)
    - cognitive decline as measured with the Brief Assessment of Cognition in Schizophrenia (BACS) from baseline to endpoint (12 weeks)
    - symptom severity as measured with the Brief Negative Symptom Scale (BNSS) from baseline to endpoint (12 weeks)
    - functional outcome (PSP),
    - formal thought disorder (TALD)
    - health-related quality of life and quality adjusted life years (QALY) outcomes (EQ-5D)
    - use of healthcare and non-healthcare resources (iMTA-PCQ and iMTA-MCQ)
    - comorbid depression (TDI)
    - cognitive control (Stroop Test)
    - productive language abilities will be tested by analyzing speech recordings
    - Electro-encephalogram (EEG)
    - Deoxyribonucleic acid (DNA)-profile
    - Hormonal and inflammatory parameters
    - Cognitieve achteruitgang zoals gemeten met de korte beoordeling van cognitie bij schizofrenie (BACS) van baseline tot eindpunt (12 weken)
    - Ernst van de symptomen, zoals gemeten met de Brief Negative Symptom Scale (BNSS) van baseline tot eindpunt (12 weken)
    - Functionele uitkomst (PSP)
    - Formele denkstoornissen (TALD)
    - Gezondheidsgerelateerde kwaliteit van leven en de kwaliteit gecorrigeerde levensjaren (QALY) resultaten (EQ-5D)
    - Gebruik van de gezondheidszorg en niet-medische middelen (iMTA-PCQ en iMTA-MCQ)
    - Comorbide depressie (TDI)
    - Cognitieve controle (Stroop Test)
    - Productieve taalvaardigheid zal worden getest door het analyseren van spraakopnamen
    - Elektro-encephalogram (EEG)
    - Desoxyribonucleïnezuur (DNA)-profielbepaling
    - Hormonale en inflammatoire parameters
    E.5.2.1Timepoint(s) of evaluation of this end point
    At baseline, at 6 weeks of treatment, at end of treatment and at 6 months follow-up after end of treatment
    Baseline, na 6 en 12 weken behandeling en na 6 maanden follow-up na afloop van de behandeling.
    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 No
    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 Yes
    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 No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Last visit of the last subject undergoing the trial (including follow-up)
    De laatste visite van de laatste deelnemer
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 154
    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 state109
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 154
    F.4.2.2In the whole clinical trial 154
    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)
    After the 12 weeks raloxifene/placebo treatment, there is no option to
    continue with the use of raloxifene within the study. The unblinding will
    be performed after database closure; in case we find at that moment
    that raloxifene has been very effective for individual patients, we can
    discuss the situation with the patients' treating physician at that time.
    Na de 12 weken behandeling met raloxifeen/placebo is er geen
    mogelijkheid om door te gaan met raloxifeen binnen studieverband.
    Deblindering vindt plaats na het sluiten van de database. Wanneer we
    op dat moment zien dar een individuele patiënt bijzonder goed heeft
    gereageerd op raloxifeen, dan zullen we contact opnemen met de
    behandelend arts.
    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 Decision2016-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-14
    P. End of Trial
    P.End of Trial StatusOngoing
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