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    Summary
    EudraCT Number:2014-003008-53
    Sponsor's Protocol Code Number:80836009820016
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-09-10
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-003008-53
    A.3Full title of the trial
    Clonidine Augmentation Therapy in Schizophrenia
    Clonidine Augmentatie therapie in Schizofrenie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clonidine added to the current treatment of therapy resistant schizophrenia
    Een toevoeging van clonidine aan de huidige behandeling van therapie-resistente schizofrenie
    A.3.2Name or abbreviated title of the trial where available
    CATS (Clonidine Augmentation Therapy in Schizophrenia)
    CATS (Clonidine Augmentatie Therapie in Schizofrenie)
    A.4.1Sponsor's protocol code number80836009820016
    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 support
    B.4.2Country
    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 pointb.oranje-2@umcutrecht.nl
    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.5.6E-mailb.oranje-2@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.2.1.1.1Trade name Clonidine HCL
    D.2.1.1.2Name of the Marketing Authorisation holderACE pharmaceuticals
    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 nameClonidine HCL
    D.3.2Product code RVG nr: 19845=56917
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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) 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
    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, schizophreniform disorder, schizoaffective disorder
    Schizofrenie, schizofreniforme stoornis, schizoaffectieve stoornis
    E.1.1.1Medical condition in easily understood language
    Schizophrenia, psychosis-related disorder
    Schizofrenie, psychose-gerelateerde stoornis
    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
    The primary aim is to investigate whether six weeks augmentation with clonidine of the antipsychotic treatment will reduce positive and negative symptomatology of treatment resistant schizophrenia patients.
    Het primaire doel van de studie is te onderzoeken of augmentatie met clonidine bij therapie-resistente patiënten met schizofrenie vermindering geeft van positieve en negatieve symptomen.
    E.2.2Secondary objectives of the trial
    Secondary goals of this project are to determine whether this treatment will improve cognitive functioning and daily functioning in these treatment resistant schizophrenia patients. Also, parameters of basic information processing, measured with EEG will be assessed as a secondary outcome.

    -General functioning (tested by "Global Assessment of Functioning", GAF)
    -Cognitive functioning (tested by "Brief Assessment in Cognition", BACS and "The Cambridge Neuropsychological Test Automated Battery", CANTAB)
    -Depressive symptoms (tested by "Calgary Depression Scale For Schizophrenia", CDSS)
    -Safety data will be evaluated by comparing incidences (number and percentage of subjects with at least one occurrence) of key SEAs and SUSARs (e.g. hospitalizations)
    -Psychophysiological parameters (tested by "Copenhagen Psychophysiological Test Battery", CPTB)

    Secundaire doelen van deze studie zijn om te onderzoeken of augmentatie van clonidine het cognitief functioneren en het dagelijks functioneren van patiënte met therapie-resistente schizofrenie verbetert. Tevens wordt als secundaire uitkomst het effect van clonidine augmentatie op basale informatieverwerking onderzocht middels EEG.

    -Het algemeen functioneren (getest met de "Global Assessment of Functioning", GAF)
    -Het cognitief functioneren (getest met de "Brief Assessment in Cognition", BACS en de "The Cambridge Neuropsychological Test Automated Battery, CANTAB)
    -Depressieve symptomen (getest met "Calgary Depression Scale For Schizophrenia, CDSS)
    -Veiligheidsinformatie, waarbij specifieke SAE's/SUSAR worden vergeleken met betrekking tot o.a. aantal (bijv. hospitalisaties).
    -Het effect op psychofysiologische parameters van basale informatieverwerking (Getest met de "Copenhagen Psychophysiological Test Battery, CPTB")
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A DSM-IV-R diagnosis of: 295.x (schizophrenia, schizophreniform disorder, or
    schizoaffective disorder)
    2. No or only partial response to clozapine as defined by a total PANSS score of at least 80.
    3. Age 18-45 years.
    4. Patients are treated with antipsychotic medication
    5. Written informed consent
    1. Een DSM-IV-TR diagnose van: 295.x (schizofrenie, schizofreniforme stoornis of schizoaffectieve stoornis.
    2. Geen of nauwelijks respons bij behandeling met clozapine, gedefinieerd als een totaale PANSS score van tenminste 80
    3. Leeftijd tussen 18-15 jaar
    4. Patienten worden behandeld met antipsychotische medicatie
    5. Geschreven informed consent
    E.4Principal exclusion criteria
    1. Presence of any of the contra-indications of clonidine as reported in the Summary of Product Characteristics (SPC).
    2. Supine systolic blood pressure (SSBP) < 85 mm HG
    3. Pre-existent orthostatic hypotension with a drop of systolic blood pressure of > 20 mmHg or a drop of diastolic blood pressure of >10 mmHg.
    4. Supine heart rate (SHR) < 50 beats/min
    5. Severe brady-arhytmias such as sick-sinussyndroom, second or third degree AV-block.
    6. Pregnancy or breast-feeding. A urine pregnancy test will be performed at screening.
    1. De aanwezigheid van contra-indicaties voor clonidine, beschreven in de samenvatting van product eigenschappen (SPC)
    2. Liggend gemeten bloeddruk <85 mmHg
    3. Pre-existente orthostatische hypotensie met een daling van >20 mmHg systolisch of een daling van >10 mmHG diastolisch
    4. Liggende hartfrequentie <50 slagen/min
    5. Ernstige brady-arhytmieën zoals sich-sinussyndroon, tweede of derdegraads AV-blok
    6 Zwangerschap, of borstvoeding geven. Urine-zwangerschapstest wordt uitgevoerd bij de screening.
    E.5 End points
    E.5.1Primary end point(s)
    Change in total score on the Positive and Negative Symptom Scale (PANSS) from baseline to endpoint (6 weeks)
    Verandering in totale score op de Positive and Negative Symptom Scale (PANSS) vanaf baseline tot eindpoint (6 weken)
    E.5.1.1Timepoint(s) of evaluation of this end point
    PANSS will be measured at baseline, halftime (3 weeks after baseline) and at the end (6 weeks after baseline) of the study.
    PANSS wordt gemeten bij baseline, halverwege (3 weken na baseline) en aan het eind (6 weken na baseline) van de studie.
    E.5.2Secondary end point(s)
    Secondary objectives concern the comparison of the 2 groups with regards to changed in:
    -General functioning (tested by "Global Assessment of Functioning", GAF)
    -Cognitive functioning (tested by "Brief Assessment in Cognition", BACS and "The Cambridge Neuropsychological Test Automated Battery", CANTAB)
    -Depressive symptoms (tested by "Calgary Depression Scale For Schizophrenia", CDSS)
    -Safety data will be evaluated by comparing incidences (number and percentage of subjects with at least one occurrence) of key SEAs and SUSARs (e.g. hospitalizations)
    -Psychophysiological parameters (tested by "Copenhagen Psychophysiological Test Battery", CPTB)
    Secundaire objectieven vergelijken de 2 groepen met betrekking tot veranderingen in:
    -Het algemeen functioneren (getest met de "Global Assessment of Functioning", GAF)
    -Het cognitief functioneren (getest met de "Brief Assessment in Cognition", BACS en de "The Cambridge Neuropsychological Test Automated Battery, CANTAB)
    -Depressieve symptomen (getest met "Calgary Depression Scale For Schizophrenia, CDSS)
    -Veiligheidsinformatie, waarbij specifieke SAE's/SUSAR worden vergeleken met betrekking tot o.a. aantal (bijv. hospitalisaties).
    -Het effect op psychofysiologische parameters van basale informatieverwerking (Getest met de "Copenhagen Psychophysiological Test Battery, CPTB")
    E.5.2.1Timepoint(s) of evaluation of this end point
    BACS: Baseline and final (6 weeks after baseline) visit
    CANTAB: Baseline and final (6 weeks after baseline) visit
    GAF: Baseline and final (6 weeks after baseline) visit.
    CPTB: Baseline, halftime (3 weeks after baseline) and final (6 weeks after baseline) visit
    CDSS: Baseline, halftime (3 weeks after baseline) and final (6 weeks after baseline) visit
    BACS: Baseline en laatste (6 weken na baseline) visite
    CANTAB: Baseline en laatste (6 weken na baseline) visite
    GAF: Baseline en laatse (6 weken na baseline) visite
    CPTB: Baseline, halftime (3 weken na baseline) en laatste (6 weken na baseline) visite
    CDSS: Baseline, halftime (3 weken na baseline) en laatste (6 weken na baseline) visite
    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 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 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 No
    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
    The last visit of the last subject
    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 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: 75
    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 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 state75
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 75
    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 6 weeks clonidine/placebo treatment, there is no option to continue with the use of clonidine within the study. The unblinding will be performed after database closure; in case we find at that moment that clonidine has been very effective for individual patients, we can discuss the situation with the patients' treating physician at that time.
    Na de 6 weken behandeling met clonidine/placebo is er geen mogelijkheid om door te gaan met clonidine 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 clonidine, 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 Decision2014-09-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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