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Pharmacogenomic biomarkers as clinical decision making tools for clozapine treatment of schizophrenia

Objective

Treatment resistant schizophrenia (TRS) is the most disabling of all psychiatric illnesses, affecting about 1/3 of patients (~1 million Europeans), a considerable economic and social burden. First-line treatments include atypical (e.g. olanzapine) and typical (e.g. haloperidol) antipsychotics. The original atypical, clozapine, is a final option, and although it is the only antipsychotic shown to be effective in TRS, about half of TRS patients are also resistant to clozapine. CRESTAR is an SME-driven projected, focusing on the development of pharmacogenomic biomarkers for schizophrenia. It aims to develop tools to predict i) who will NOT respond to usual antipsychotics, indicating treatment with clozapine as early as possible, ii) the 1% of patients who will develop potentially fatal side effects, agranulocytosis, which is the main factor limiting clozapine use, and diabetic ketoacidosis, occurring in up to 2% of patients, and often fatal. We will also predict patients likely to be non-responders to all antipsychotics, i.e. extreme TRS, so that they can be stratified in clinical trials. CRESTAR will address these questions by examining genome-wide association data, genome sequence, epigenetic biomarkers and epidemiological data in European patient cohorts characterized for treatment response, and adverse drug reaction using data from clozapine therapeutic drug monitoring and linked National population medical and pharmacy databases, alongside existing European projects (e.g. PSYCNVs and EU-GEI) national initiatives (e.g. UK10K genome sequencing) to identify predictive factors. In parallel CRESTAR will perform health economic research on potential benefits, and ethics and patient-centered research with stakeholders. The outcome of CRESTAR will be a genomic test and associated clinical decision making tools, designed to improve pharmacological treatment of schizophrenia in both efficacy and safety, piloted with existing and new clinical trials such as OPTiMiSE.

Call for proposal

FP7-HEALTH-2011-two-stage
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Coordinator

KING'S COLLEGE LONDON
Address
Strand
WC2R 2LS London
United Kingdom

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Paul Labbett (Mr.)
EU contribution
€ 923 251

Participants (10)

ISLENSK ERFDAGREINING EHF
Iceland
EU contribution
€ 1 843 949
Address
Sturlugotu 8
101 Reykjavik

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Bjorgvin Richardsson (Mr.)
LANDSPITALI UNIVERSITY HOSPITAL
Iceland
EU contribution
€ 241 000
Address
Eiriksgata 5
101 Reykjavik

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Engilbert Sigurdsson (Prof.)
LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN

Participation ended

Germany
EU contribution
€ 153 012,40
Address
Geschwister Scholl Platz 1
80539 Muenchen

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Dan Rujescu (Prof.)
CARDIFF UNIVERSITY
United Kingdom
EU contribution
€ 642 964
Address
Newport Road 30 36
CF24 0DE Cardiff

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Nick Bodycombe (Mr.)
AARHUS UNIVERSITET
Denmark
EU contribution
€ 652 271
Address
Nordre Ringgade 1
8000 Aarhus C

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Karin Lykke (Ms.)
ZENTRALINSTITUT FUER SEELISCHE GESUNDHEIT
Germany
EU contribution
€ 605 647
Address
Square J 5
68159 Mannheim

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Simone Fuchs
CONCENTRIS RESEARCH MANAGEMENT GMBH
Germany
EU contribution
€ 285 000
Address
Ludwigstr. 4
82256 Furstenfeldbruck

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ameli Schwalber (Ms.)
LEYDEN DELTA BV
Netherlands
EU contribution
€ 142 750
Address
Kerkenbos 1236 A
6546 BE Nijmegen

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Esther Nijholt-Faber (Dr.)
MARTIN-LUTHER-UNIVERSITAT HALLE-WITTENBERG
Germany
EU contribution
€ 510 155,60
Address
Universitatsplatz 10
6108 Halle

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Activity type
Higher or Secondary Education Establishments
Administrative Contact
Sigrid Köhne (Dr.)
ELI LILLY AND COMPANY LTD
United Kingdom
Address
Lilly House Basingview
RG21 4FA Basingstoke

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Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Claudio Bertoli