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    Summary
    EudraCT Number:2009-012031-15
    Sponsor's Protocol Code Number:01KG0910
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-16
    Trial results View 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 ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2009-012031-15
    A.3Full title of the trial
    Efficacy of early antipsychotic switch versus maintenance in patients with schizophrenia poorly responding to two weeks of antipsychotic treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    NA
    A.3.2Name or abbreviated title of the trial where available
    The Switch study
    NA
    A.4.1Sponsor's protocol code number01KG0910
    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 SponsorTechnische Universitaet Munchen, vertreten durch das Klinikum rechts
    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 supportTechnische Universitaet Munchen, vertreten durch das Klinikum rechts
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTangent Data
    B.5.2Functional name of contact pointPaull Radu
    B.5.3 Address:
    B.5.3.1Street AddressPopa nan, no 15
    B.5.3.2Town/ cityBucharest
    B.5.3.3Post code030581
    B.5.3.4CountryRomania
    B.5.4Telephone number0213233224
    B.5.5Fax number0213204432
    B.5.6E-mailpaull.radu@tangentdata.com
    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 Amisulprid Hexal 50 mg
    D.2.1.1.2Name of the Marketing Authorisation holderHEXAL - HEXAL AG Industriestr. 25 83607 Holzkirchen
    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 nameAmisulpride
    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 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 Yes
    D.3.11.13.1Other medicinal product typeantipsychotic
    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 Zyprexa 2.5mg coated tablet
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V., Grootslag 1 – 5, NL-3991 RA Houten, Netherlands
    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 nameOlanzapine
    D.3.2Product code NA
    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 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 Yes
    D.3.11.13.1Other medicinal product typeantipsyhotic
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with a diagnosis of schizophrenia , schizophreniform disorder or schizoaffective disorder according to DSM-IV TR criteria; experiencing an acute episode of their illness
    Schizophrenia, schizo-affective disorder or schizophrenieform disorder
    E.1.1.1Medical condition in easily understood language
    NA
    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 objective of the current trial is to demonstrate the superior effectiveness of an early switch of antipsychotic treatment in patients poorly responding to two weeks of randomized treatment with either olanzapine or amisulpride. The primary endpoint is the number of patients in remission after another six weeks of treatment after either continuing on the initially started antipsychotic or having been switched to the alternative study drug.
    NA
    E.2.2Secondary objectives of the trial
    Change in psychopathology (PANSS total change), overall costs of treatment, treatment safety, subjective well-being under neuroleptic treatment, attitude toward antipsychotic treatment, pharmacogenetics
    NA
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    NA
    E.3Principal inclusion criteria
    1. Male or female inpatients, 18 to 65 years of age. 2. Participants must have a diagnosis of schizophrenia, or schizophreniform disorder or schizoaffective disorder as defined in DSM-IV TR, verified by the M.I.N.I. interview at screening. 3. At study entry a Positive and Negative Syndrome Scale (PANSS, Kay et al. 1987) total score of at least 75 AND a score of ≥ 4 on any two of the items of the positive component factors (i.e. delusions, unusual thought content, hallucinatory behaviour, suspiciousness, grandiosity, lack of judgement and insight) AND at least a rating of "4 = moderately ill" according to the Clinical Global Impression Scale (Guy 1976) to assure that participants are symptomatic. 4. Increase in the level of care due to current acute episode (i.e. outpatient care to inpatient or day-clinic care) and this increase in care took place no longer than 3 working days before study entry 5. Able to give informed consent. 6. The criterion for the second randomisation is less than 25% Positive and Negative Syndrome Scale (PANSS, Kay et al. 1987) total score reduction from baseline.
    NA
    E.4Principal exclusion criteria
    1. Contraindications for amisulpride or olanzapine (allergies, pregnancy etc). 2. Known treatment resistance to study drugs as defined by the American/German/World Federation of Biological Psychiatry schizophrenia practice guidelines (Falkai et al. 2005, Lehman et al. 2004, Gaebel et al. 2006): insufficient response despite a trial of at least 4 to 6 weeks duration with sufficient doses (olan-zapine 15-20mg/day, amisulpride 600-800 mg/day), and despite appropriate compliance. 3. Continuous treatment with study drugs in sufficient doses (olanzapine 15-20mg, amisulpride 600-800mg) and with adequate compliance in the 2 weeks before study entry 4. Increase in the level of care (outpatient care to inpatient or day-clinic care) due to social reasons or side effect burden or >3 working days prior to study entry for any reason 5. Current acute episode remained on a clinically unchanged level for 4 weeks prior to study entry despite adequate treatment and sufficient compliance with the treatment 6. Received depot antipsychotic within 1 dose interval before inclusion, in the case of risperidone Consta last injection within 5 weeks (long half life of depots which would interact with study drugs, risperidone consta has a special metabolism). 7. Actively suicidal (double-blind treatment unethical). 8. Pregnancy (antipsychotic drug treatment very problematic). 9. Patients with an DSM-IV TR diagnosis of a substance dependence (abuse is allowed to enhance gener-alisability) other than nicotine or caffeine within 3 months prior to baseline (these substances can interact with study drugs). 10. Serious medical illnesses (double-blind psychotropic medication unethical)
    NA
    E.5 End points
    E.5.1Primary end point(s)
    Our primary outcome will be the number of participants in remission according to the criteria of the remission in schizophrenia work group (RSWG; Andreasen et al. 2005). According to these criteria remission means that 8 specific symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (Kay et al. 1987) are at the most only mildly present so that they do not interfere with daily life functioning. We will compare the number of patients in remission in the "swicht group" (i.e. patients poorly responded and were randomiserd to the alternative treatment after 2 weeks of initial treatment) and in the "maintenance group" (i.e. patients poorly responded and were randomized to stay with their initially started antipsychotic treatment having received 2 weeks of this drug) after the total treatment duration of 8 weeks.
    NA
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    NA
    E.5.2Secondary end point(s)
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.6.13.1Other scope of the trial description
    NA
    NA
    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 No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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
    The end of the trial is the last visit of the last subject undergoing the trial
    NA
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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 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: 500
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 500
    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)
    30 days followup after the last visit of the trial, for each patient.
    NA
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-02-06
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