CRESTAR

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

 Coordinatore KING'S COLLEGE LONDON 

 Organization address address: Strand
city: LONDON
postcode: WC2R 2LS

contact info
Titolo: Mr.
Nome: Paul
Cognome: Labbett
Email: send email
Telefono: +44 207 848 8184
Fax: +44 207 848 8187

 Nazionalità Coordinatore United Kingdom [UK]
 Sito del progetto http://www.crestar-project.eu/
 Totale costo 7˙989˙912 €
 EC contributo 6˙000˙000 €
 Programma FP7-HEALTH
Specific Programme "Cooperation": Health
 Code Call FP7-HEALTH-2011-two-stage
 Funding Scheme CP-FP
 Anno di inizio 2011
 Periodo (anno-mese-giorno) 2011-11-01   -   2015-10-31

 Partecipanti

# participant  country  role  EC contrib. [€] 
1    KING'S COLLEGE LONDON

 Organization address address: Strand
city: LONDON
postcode: WC2R 2LS

contact info
Titolo: Mr.
Nome: Paul
Cognome: Labbett
Email: send email
Telefono: +44 207 848 8184
Fax: +44 207 848 8187

UK (LONDON) coordinator 923˙251.00
2    ISLENSK ERFDAGREINING EHF

 Organization address address: Sturlugata 8
city: REYKJAVIK
postcode: 101

contact info
Titolo: Mr.
Nome: Bjorgvin
Cognome: Richardsson
Email: send email
Telefono: +354 570 1821

IS (REYKJAVIK) participant 1˙806˙449.00
3    CARDIFF UNIVERSITY

 Organization address address: Newport Road 30-36
city: CARDIFF
postcode: CF24 ODE

contact info
Titolo: Mr.
Nome: Nick
Cognome: Bodycombe
Email: send email
Telefono: +44 29 2087 0171
Fax: +44 29 2087 4189

UK (CARDIFF) participant 663˙214.00
4    AARHUS UNIVERSITET

 Organization address address: Nordre Ringgade 1
city: AARHUS C
postcode: 8000

contact info
Titolo: Ms.
Nome: Karin
Cognome: Lykke
Email: send email
Telefono: 4589428142

DK (AARHUS C) participant 652˙271.00
5    ZENTRALINSTITUT FUER SEELISCHE GESUNDHEIT

 Organization address address: Square J 5
city: MANNHEIM
postcode: 68159

contact info
Nome: Simone
Cognome: Fuchs
Email: send email
Telefono: +49 621 1703 1321
Fax: +49 621 1703 2915

DE (MANNHEIM) participant 605˙647.00
6    MARTIN-LUTHER-UNIVERSITAET HALLE-WITTENBERG

 Organization address address: UNIVERSITAETSPLATZ 10
city: HALLE (Saale)
postcode: 6099

contact info
Titolo: Dr.
Nome: Sigrid
Cognome: Köhne
Email: send email
Telefono: +49 345 5521303
Fax: +49 345 5527396

DE (HALLE (Saale)) participant 510˙155.60
7 Concentris Research Management GmbH DE participant 285˙000.00
8    LANDSPITALI UNIVERSITY HOSPITAL

 Organization address address: Eiriksgata 5
city: REYKJAVIK
postcode: 101

contact info
Titolo: Prof.
Nome: Engilbert
Cognome: Sigurdsson
Email: send email
Telefono: +354 824 5345
Fax: +354 543 4816

IS (REYKJAVIK) participant 241˙000.00
9    LEYDEN DELTA BV

 Organization address address: KERKENBOS 1236 A
city: NIJMEGEN
postcode: 6546 BE

contact info
Titolo: Dr.
Nome: Esther
Cognome: Nijholt-Faber
Email: send email
Telefono: +31 24 3726 272
Fax: +31 24 3726 270

NL (NIJMEGEN) participant 160˙000.00
10    LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN

 Organization address address: GESCHWISTER SCHOLL PLATZ 1
city: MUENCHEN
postcode: 80539

contact info
Titolo: Prof.
Nome: Dan
Cognome: Rujescu
Email: send email
Telefono: +49 89 5160 5756

DE (MUENCHEN) participant 153˙012.40
11    Eli Lilly and Company Limited

 Organization address address: "Lilly House, Priestley Road"
city: Basingstoke
postcode: RG24 9NL

contact info
Nome: Claudio
Cognome: Bertoli
Email: send email
Telefono: +44 1256 775098
Fax: +44 1256 775671

UK (Basingstoke) participant 0.00

Mappa


 Word cloud

Esplora la "nuvola delle parole (Word Cloud) per avere un'idea di massima del progetto.

health    pharmacogenomic    national    trials    treatment    genome    safety    biomarkers    anti    atypical    genetic    responders    drug    economic    clozapine    clinical    http    social    outcome    epidemiological    crestar    final    schizophrenia    tests    data    original    predict    tools    scientists    half    trs    psychotics    reaction    potentially    monitoring    decision    antipsychotic    psychotic    adverse    fatal    resistant    patient    reduce    patients    predictive    antipsychotics   

 Obiettivo del progetto (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.'

Introduzione (Teaser)

Schizophrenia is a debilitating mental illness. EU-funded scientists are developing biomarkers and predictive tests to identify particularly difficult cases early for faster access to the only anti-psychotic that can help.

Descrizione progetto (Article)

A disconcerting third of schizophrenia patients exhibit treatment-resistant schizophrenia (TRS), with up to half of these not responding to any medication. The rest respond only to clozapine, the original atypical anti-psychotic treatment. The earlier the drug is administered, the better the outcome.

The project http://www.crestar-project.eu/ (CRESTAR) (Pharmacogenomic biomarkers as clinical decision-making tools for clozapine treatment of schizophrenia) is exploiting genetics, epigenetics and epidemiological data from patients characterised for treatment response and adverse drug reaction. This approach should help identify patients' refractory to anti-psychotics and those who will develop potentially fatal side-effects from clozapine, particularly worrisome in children and adolescents. The patients most likely to be non-responders to all anti-psychotics were also recorded.

To date, scientists have TRS genotyped some 16 500 patients being treated with clozapine. Integrated analysis across Europe with clinical data, including epidemiological data from the Danish National Registry accelerated the discovery of genetic factors and biomarkers influencing clozapine consumption in schizophrenia patients.

The data has been used to develop a commercially viable array-based pharmacogenetic test for clozapine effects, CLOZACHIP. The researchers have now defined algorithms and are developing the parameters for use in cost-effective risk prediction. This will reduce the economic cost of treatment and improve quality of life for the patient.

Investigators have also defined TRS phenotypes and genotypes in schizophrenia populations and are working toward determining genetic associations and the causes of TRS. The analysis is poised to be complete in the next and final project period.

The researchers expect to be in a positon in the final phase to translate biomarker data analysis into the clinical arena. Such evidence-based guide on the use and monitoring of antipsychotic drugs, particularly clozapine promises to improve drug function and increase longevity for patients with TRS.

CRESTAR deliverables will reduce the need for hospitalisation, lower costs of trials and the economic impact on health systems while increasing safety and success record of clinical tests. Dissemination through the http://www.crestar-project.eu/ (project website), workshops and publications will also help to reduce any social stigma associated with schizophrenia.

Altri progetti dello stesso programma (FP7-HEALTH)

ANTIFLU (2011)

Innovative anti-influenza drugs excluding viral escape

Read More  

IHMS (2011)

International Human Microbiome Standards

Read More  

OSTEOGROW (2012)

Novel Bone Morphogenetic Protein-6 Biocompatible Carrier Device for Bone Regeneration

Read More