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    Summary
    EudraCT Number:2014-001968-35
    Sponsor's Protocol Code Number:SPIROTREAT
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-01-23
    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 number2014-001968-35
    A.3Full title of the trial
    Add-on spironolactone for the treatment of schizophrenia
    Evaluation der Effektivität der add-on Behandlung von Spironolacton bei Patienten mit einer Schizophrenie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Add-on spironolactone for the treatment of schizophrenia
    Evaluation der Effektivität der add-on Behandlung von Spironolacton bei Patienten mit einer Schizophrenie
    A.3.2Name or abbreviated title of the trial where available
    SPIROTREAT
    A.4.1Sponsor's protocol code numberSPIROTREAT
    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 SponsorKlinikum der Universität München - AöR vertreten durch den Vorstand des Bereiches umanmedizinH
    B.1.3.4CountryGermany
    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 organisationMuenchner Studienzentrum
    B.5.2Functional name of contact pointBeate Schossow
    B.5.3 Address:
    B.5.3.1Street AddressIsmaninger Str. 22
    B.5.3.2Town/ cityMuenchen
    B.5.3.3Post code81675
    B.5.3.4CountryGermany
    B.5.4Telephone number00498941406469
    B.5.5Fax number00498941406322
    B.5.6E-mailbeate.schossow@mri.tum.de
    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 Spironolacton HEXAL
    D.2.1.1.2Name of the Marketing Authorisation holderHexal
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSpironolacton HEXAL
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 52-01-7
    D.3.9.2Current sponsor codeSPIROTREAT
    D.3.9.3Other descriptive nameSPIRONOLACTON
    D.3.9.4EV Substance CodeSUB10631MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 2
    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 Spironolacton HEXAL
    D.2.1.1.2Name of the Marketing Authorisation holderHEXAL
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameSpironolacton HEXAL
    D.3.2Product code C03DA01
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 52-01-7
    D.3.9.2Current sponsor codeSPOIROTREAT
    D.3.9.3Other descriptive nameSPIRONOLACTONE
    D.3.9.4EV Substance CodeSUB10631MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 (2x50mg)
    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 placeboCapsule, hard
    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
    Schizophrenie
    E.1.1.1Medical condition in easily understood language
    Schizophrenia
    Schizophrenie
    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 21.1
    E.1.2Level LLT
    E.1.2Classification code 10039643
    E.1.2Term Schizophrenic psychoses
    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
    Primary endpoint: Improvement of working memory in n-back after 3 weeks.
    E.2.2Secondary objectives of the trial
    Secondary endpoints: Improvement of other neurocognitive functions after 3 and 12 weeks (verbal memory, working speed), changes in psychopathology of PANSS and CDSS, changes in CGI and GAF, occurrence of single side effects, changes of cortical inhibition, changes in ERBB4 metabolic pathway
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Essential inclusion Criteria:
    Male and female patients with schizophrenia (ICD-10 Criteria), no longer in acute phase of illness (PANSS Total ≤ 75, CGI ≤ 4), duration of illness > 6 months, age between 18 and 65 years
    Have need for a combination treatment with a maximum of 2 antipsychotics. Excluded antipsychotics can be found under 4.3.
    Wesentliche Einschlusskriterien: Männliche und weibliche Patienten mit Schizophrenie (ICD-10 Kriterien), die sich nicht mehr in der akuten Krankheitsphase befinden (PANSS Total ≤ 75, CGI ≤ 4), Krankheitsdauer > 6 Monate, Alter zwischen 18 und 65 Jahren
    Notwendigkeit für eine Kombinationsbehandlung mit maximal 2 Antipsychotika haben. Ausgeschlossene Antipsychotika finden sich unter 4.3.
    E.4Principal exclusion criteria
    Essential exclusion Criteria:
    Female Patients: Pregnancy, no medically-approved methods of contraception. Current suicidality as well as injuries to others, severe neurological and internistic comorbidities, known and assumed non-compliance regarding intake of medication, current antipsychotic therapy with clozapine, antipsychotic treatment with exclusively a renal eliminable compound (amisulprid), planned antipsychotic combination treatment, no new dosing of mood stabilisers or antidepressants during 3-week intervention phase. An already existing mood stabiliser therapy (excluding lithium) or antidepressant therapy (excluding renal eliminable antidepressant) can be continued in unaltered dose. Alcohol- or substance abuse during the last 6 months before inclusion into study; nicotine and coffee are excluded. Epileptic seizures in anamnesis (only for additional examination TMS with separate Informed Consent Form), known intolerance of the respective study medication, current anuresis or acute kidney failure, kidney insufficiency (creatinine clearance < 30 ml/min per 1.73 m² body surface, resp. serum-creatinine > 1.8 mg/dl), known clinically relevant hyperkalaemia or hyponatraemia, known clinically relevant hypotension (RR < 100/80), simultaneous application of potassium-sparing diuretics, ACE inhibitors or AT-II antagonists, NSAR, thiazide-diuretics, carbenoxolon, digoxin, neomycin, lithium. Missing capacity for consent or hospitalisation of patients against their will, insufficient knowledge of the German language, state of treatment resistance or never treated schizophrenia.
    Known clinical need for antipsychotic combination treatment with more than two antipsychotics.
    Wesentliche Ausschlusskriterien:
    Bei weiblichen Teilnehmern: Bestehende Schwangerschaft , keine sichere Verhütungsmetholde entsprechend der CTFG-Leitlinie
    Gegenwärtige Suizidalität sowie Fremdgefährdung, schwere neurologische und internistische Komorbiditäten, bekannte oder vermutete non-compliance hinsichtlich der Medikamenteneinnahme, aktuelle antipsychotische Therapie mit Clozapin, antipsychotische Behandlung mit einem auschließlich renal eliminierbaren Präparat (z.B. Amisulprid), bekannte klinische
    bekannte klinische Notwendigkeit einer antipsychotischen Kombinationsbehandlung mit mehr als zwei Antipsychotika.
    Geplante Eindosierung von Stimmungsstabilisierern oder Antidepressiva während der 3-wöchigen Interventionsphase.
    Eine vorher bestehende Therapie mit einem Stimmungsstabilisierer (außer Lithium) oder einem Antidepressivum (außer renal eliminierbarer Antidepressiva) kann in unveränderter Dosis fortgesetzt werden. Alkohol- oder Substanzabhängigkeit innerhalb der letzten sechs Monate vor Studieneinschluss. Nikotin und Koffein sind hiervon ausgenommen. Epileptische Anfälle in der Anamnese (gilt nur für die TMS Zusatzuntersuchung mit separater Patienteninformation/Einwilligungserklärung), bekannte Unverträglichkeit zu einem der Studienmedikamente, bestehende Anurie oder akutes Nierenversagen, Niereninsuffizienz (Kreatinin Clearance unter 30 ml/min pro 1.73 m² Körperoberfläche bzw. Serum-Kreatinin über 1.8 mg/dl), bekannte klinisch relevante Hyperkaliämie oder Hyponatriämie, bekannte klinisch relevante Hypotonie (RR < 100/80), gleichzeitige Anwendung von Kalium-sparenden Diuretika, ACE-Hemmern oder ATII-Antagonisten, NSAR, Thiaziddiurektika, Carbenoxolon, Digoxin, Neomycin, Lithium, fehlende Einwilligungsfähigkeit oder Unterbringung gegen den Willen des Patienten, unzureichende Kenntnis der deutschen Sprache, Zustand der Behandlungsresistenz oder noch nie behandelte Schizophrenie
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: Improvement of working memory in n-back (2-back hits) after 3 weeks.
    Verbesserung des Arbeitsgedächtnisses im n-back (2-back Treffer) nach drei Wochen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 weeks
    3 Wochen
    E.5.2Secondary end point(s)
    Secondary endpoints: Improvement of other neurocognitive functions after 3 and 12 weeks (further parameters of working memory) verbal memory, working speed), changes in psychopathology of PANSS and CDSS, changes in CGI and GAF, occurrence of single side effects, changes of cortical inhibition, changes in ERBB4 metabolic pathway. Comparison of both verum arms vs. placebo
    Verbesserung anderer neurokognitiver Funktionen nach drei und acht Wochen (weitere Arbeitsgedächtnisparameter, verbales Gedächtnis, Arbeitsgeschwindigkeit), Veränderung in der Psychopathologie nach PANSS und CDSS, Veränderung im CGI und GAF, Auftreten von einzelnen Nebenwirkungen, Veränderung der kortikalen Inhibition, Veränderung im ERBB4 Stoffwechselweg. Vergleich der beiden Verum-Arme gepoolt vs. Plazeboarm
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 3 and 12 weeks
    nach drei und acht Wochen
    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 No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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 trial3
    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 concerned3
    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
    Last Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 90
    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 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 state90
    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 end of the study patients regardless of whether the study end according to the protocol or early / non-terminated according to protocol, the patient get the antipsychotic therapy which they had taken. Even switching to a different medication is possible.
    Nach Ende der Studie können Patienten unabhängig davon, ob die Studie protokollgemäß oder vorzeitig/nicht-protokollgemäß beendet wurde, mit demjenigen Antipsychotikum weiterbehandelt werden, das sie eingenommen hatten. Auch eine Umstellung auf ein anderes Medikament ist möglich.

    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 Decision2015-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-11
    P. End of Trial
    P.End of Trial StatusOngoing
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