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    Summary
    EudraCT Number:2010-022184-35
    Sponsor's Protocol Code Number:ATLAS
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-09-06
    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 ConcernedUK - MHRA
    A.2EudraCT number2010-022184-35
    A.3Full title of the trial
    A pragmatic randomised double-blind trial of Antipsychotic Treatment of very LAte-onset Schizophrenia-like psychosis: The ATLAS Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial to test the effect of amisulpride (antipsychotic) on schizoprenia like disease with onset after age 60
    A.3.2Name or abbreviated title of the trial where available
    The ATLAS Trial
    A.4.1Sponsor's protocol code numberATLAS
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN45593573
    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 SponsorKing's College London
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial Service Unit
    B.5.2Functional name of contact pointATLAS Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressRichard Doll Building, Old Road Campus, Roosevelt Drive
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX3 7LF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865743904
    B.5.5Fax number01865765615
    B.5.6E-mailatlas2@ctsu.ox.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorSouth London and Maudsley NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial Service Unit
    B.5.2Functional name of contact pointATLAS Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressRichard Doll Building, Old Road Campus, Roosevelt Drive
    B.5.3.2Town/ cityOxford
    B.5.3.3Post codeOX3 7LF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865743904
    B.5.5Fax number01865765615
    B.5.6E-mailatlas2@ctsu.ox.ac.uk
    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.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 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 INNAMISULPRIDE
    D.3.9.1CAS number 71675-85-9
    D.3.9.4EV Substance CodeSUB05458MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 placeboTablet
    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
    late-onset schizophrenia-like psychosis
    E.1.1.1Medical condition in easily understood language
    Patients who develop schizophrenic symptoms and psychosis later in life
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10037234
    E.1.2Term Psychosis
    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
    (1) Is amisulpride superior to placebo in the treatment of very late-onset schizophrenia-like psychosis over 12 weeks as measured by significant differences between amisulpride and placebo treated groups in improvements in score on the brief psychiatric rating scale (BPRS) largely driven by improvements in the hostility, suspiciousness, hallucinations, tension, uncooperativeness and motor hyperactivity sub-scores?
    (2) Is prolonged treatment after 12 weeks superior to treatment withdrawal to receive placebo over the next 12 weeks as measured by significant differences in BPRS scores between groups and significantly greater numbers of patients in the group randomised to receive placebo being withdrawn to open treatment with amisulpride by their physicians?
    E.2.2Secondary objectives of the trial
    In addition to the two principal questions we will also investigate the associated risks of side-effects and serious adverse events, the effects of treatment upon quality of life and the cost-effectiveness of amisulpride treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (i) Diagnosis of very late-onset schizophrenia-like psychosis as defined by International Consensus Group criteria, including onset of delusions and/or hallucinations after the age of 60 years,
    (ii) BPRS score ≥30, or active psychotic symptoms of a nature and severity that would be consistent with a BPRS score of 30 or greater
    (iii) Capacity to give informed consent to inclusion in trial (in the view of the responsible physician).
    E.4Principal exclusion criteria
    (i) Evidence of significant cognitive impairment and standardised MMSE score <25,
    (ii) Uncontrolled serious concomitant physical illness,
    (iii) Primary diagnosis of affective disorder,
    (iv) Prescribed amisulpride in previous 28 days. (Patients who have been treated with other antipsychotic agents in the previous 28 days but still satisfy the eligibility criteria, and stopping current antipsychotic is considered appropriate, can participate and this will be included as a stratification factor at randomisation);
    (v) Contraindication to amisulpride (e.g. phaeochromocytoma, prolactin dependent tumour or potential drug interactions: e.g. with levodopa - see most recent Summary of Product Characteristics http://emc.medicines.org.uk/);
    (vi) Participation in another Clinical Trial of an Investigational Medicinal Product (IMP) in the previous 28 days; or
    (vii) Conditions which would prevent participants from having a blood test (eg needle phobia), or may lead to distress during attempts to take blood (eg history of poor intravenous access) will exclude participants from taking part in the optional blood test, but will NOT affect their participation in the trial
    E.5 End points
    E.5.1Primary end point(s)
    Brief Psychiatric Rating Scale, a widely used 24-item instrument for assessing positive, negative and affective symptoms in patients with psychotic disorders. Numbers of patients withdrawn from treatment because of perceived ineffectiveness are the trial’s co-primary outcomes for the second (week 12 to 24) stage.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Changes in BPRS score between Baseline and 12 Weeks and between Week 12 and Week 24
    E.5.2Secondary end point(s)
    Extrapyrimidal side-effects, compliance, quality of life and cost-effectiveness
    E.5.2.1Timepoint(s) of evaluation of this end point
    4, 10-12, 16 and 22-24 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 Yes
    E.6.4Safety Yes
    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.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 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 concerned25
    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
    LPLV
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients who are detained as in-patients under the Mental Health Act may be recruited for this trial
    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 100
    F.4.2.2In the whole clinical trial 100
    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)
    Amisulpride is available as a cheap generic preparation and will be made available to participants as part of their usual NHS care if benefits are shown to outweigh the risks.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Mental Health Research Network
    G.4.3.4Network Country United Kingdom
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Dementias and Neurodegenerative Diseases Research Network Coordinating Centre (DeNDRoN CC)
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-14
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