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OPTIMISE

OPtimization of Treatment and Management of Schizophrenia in Europe (OPTiMiSE)

Coordinatore	UNIVERSITAIR MEDISCH CENTRUM UTRECHT Organization address address: HEIDELBERGLAAN 100 city: UTRECHT postcode: 3584 CX contact info Titolo: Ms. Nome: Mirjam Cognome: Lormans Email: send email Telefono: -7944 Fax: -6255
Nazionalità Coordinatore	Netherlands [NL]
Sito del progetto	http://www.optimisetrial.eu/
Totale costo	14˙900˙190 €
EC contributo	11˙187˙685 €
Programma	FP7-HEALTH Specific Programme "Cooperation": Health
Code Call	FP7-HEALTH-2009-single-stage
Funding Scheme	CP-IP
Anno di inizio	2010
Periodo (anno-mese-giorno)	2010-02-01 - 2016-07-31

Partecipanti

#	participant	country	role	EC contrib. [€]
1	UNIVERSITAIR MEDISCH CENTRUM UTRECHT Organization address address: HEIDELBERGLAAN 100 city: UTRECHT postcode: 3584 CX contact info Titolo: Ms. Nome: Mirjam Cognome: Lormans Email: send email Telefono: -7944 Fax: -6255	NL (UTRECHT)	coordinator	3˙205˙464.06
2	KING'S COLLEGE LONDON Organization address address: Strand city: LONDON postcode: WC2R 2LS contact info Titolo: Mrs. Nome: Silke Cognome: Blohm Email: send email Telefono: +44 (0) 20 7848 0121. Fax: +44 020 7848 0671	UK (LONDON)	participant	1˙725˙194.26
3	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	970˙695.00
4	SERVICIO MADRILENO DE SALUD Organization address address: PLAZA CARLOS TRIAS BERTRAN 7 city: MADRID postcode: 28020 contact info Titolo: Dr. Nome: Albino Cognome: Navarro Email: send email Telefono: +34 91 426 51 15 Fax: +34 91 400 81 56	ES (MADRID)	participant	742˙961.28
5	REGION HOVEDSTADEN Organization address address: KONGENS VAENGE 2 city: HILLEROD postcode: 3400 contact info Titolo: Prof. Nome: Birte Cognome: Glenthøj Email: send email Telefono: +45 43233431	DK (HILLEROD)	participant	714˙003.64
6	INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) Organization address address: 101 Rue de Tolbiac city: PARIS postcode: 75654 contact info Titolo: Mr. Nome: Didier Cognome: Lemoine Email: send email Telefono: 33145170315 Fax: 33148995407	FR (PARIS)	participant	591˙356.36
7	KLINIKUM RECHTS DER ISAR DER TECHNISCHEN UNIVERSITAT MUNCHEN Organization address address: ISMANINGER STRASSE 22 city: MUENCHEN postcode: 81675 contact info Nome: Renate Cognome: Rädlein Email: send email Telefono: +49 89 4140 2842 Fax: +49 89 4140 4926	DE (MUENCHEN)	participant	450˙136.00
8	TANGENT DATA SRL Organization address address: CALEA VICTORIEI 91-93 SC C ET P AP city: BUCURESTI postcode: 10091 contact info Titolo: Mr. Nome: Rodica Cognome: Gonen Email: send email Telefono: +40 723 586675 Fax: +40 21 2128105	RO (BUCURESTI)	participant	446˙620.20
9	THE UNIVERSITY OF MANCHESTER Organization address address: OXFORD ROAD city: MANCHESTER postcode: M13 9PL contact info Titolo: Ms. Nome: Liz Cognome: Fay Email: send email Telefono: 441613000000 Fax: +44 161 275 2445	UK (MANCHESTER)	participant	408˙047.00
10	Nome Ente NON disponibile Organization address address: VIALE BENEDUCE 10 city: CASERTA postcode: 81100 contact info Titolo: Ms. Nome: Luciana Cognome: Taliento Email: send email Telefono: -5666545 Fax: -5666565	IT (CASERTA)	participant	234˙899.76
11	MEDICAL RESEARCH INFRASTRUCTURE DEVELOPMENT AND HEALTH SERVICES FUND BY THE SHEBA MEDICAL CENTER Organization address address: TEL HASHOMER SHEBA MEDICAL CENTER city: RAMAT GAN postcode: 52621 contact info Titolo: Prof. Nome: Michael Cognome: Davidson Email: send email Telefono: 972527000000 Fax: na	IL (RAMAT GAN)	participant	224˙072.95
12	Fondation FondaMental Organization address address: "Rue de Mesly, Hopital Chenevier, Pole de Psychiatrie 40" city: Creteil postcode: 94000 contact info Nome: Maria Cognome: Chovet Email: send email Telefono: +33 1 49 81 34 30	FR (Creteil)	participant	215˙537.23
13	Clienia Schloessli AG Organization address city: Oetwil am See postcode: 8618 contact info Titolo: Dr. Nome: Gregor Cognome: Berger Email: send email Telefono: +41 (0)44 929 81 11 Fax: +41 44 929 84 50	CH (Oetwil am See)	participant	214˙537.80
14	HELMHOLTZ ZENTRUM MUENCHEN DEUTSCHES FORSCHUNGSZENTRUM FUER GESUNDHEIT UND UMWELT GMBH Organization address address: Ingolstaedter Landstrasse 1 city: MUENCHEN postcode: 85764 contact info Titolo: Dr. Nome: Juergen Cognome: Ertel Email: send email Telefono: -6249 Fax: -7093	DE (MUENCHEN)	participant	213˙204.00
15	LUDWIG-MAXIMILIANS-UNIVERSITAET MUENCHEN Organization address address: GESCHWISTER SCHOLL PLATZ 1 city: MUENCHEN postcode: 80539 contact info Titolo: Mr. Nome: Alexander Cognome: Vogl Email: send email Telefono: -5925 Fax: -5938	DE (MUENCHEN)	participant	200˙319.90
16	UNIWERSYTET MEDYCZNY IM KAROLA MARCINKOWSKIEGO W POZNANIU Organization address address: Ul. Fredry 10 city: POZNAN postcode: 61 701 contact info Titolo: Prof. Nome: Janusz Cognome: Rybakowski Email: send email Telefono: 48600321411 Fax: na	PL (POZNAN)	participant	175˙846.80
17	UNIVERZITA KARLOVA V PRAZE Organization address address: Ovocny trh 5 city: PRAHA 1 postcode: 11636 contact info Titolo: Ms. Nome: Eva Cognome: Macourkova Email: send email Telefono: +420 495 816 136 Fax: +420 495 513 597	CZ (PRAHA 1)	participant	103˙949.44
18	SPETSIALIZIRANA BOLNITSA ZA AKTIVNO LECHENIE PO NEVROLOGIA I PSIHIATRIA SV NAUM AD Organization address address: TSARIGRADSKO SHOSSE BULEVARD IV KILOMETER city: SOFIA postcode: 1113 contact info Nome: Luchezar Cognome: Hranov Email: send email Telefono: 35929702230	BG (SOFIA)	participant	92˙376.80
19	MEDIZINISCHE UNIVERSITAET INNSBRUCK Organization address address: Christoph-Probst Platz 1 city: INNSBRUCK postcode: 6020 contact info Titolo: Dr. Nome: Peter Cognome: Josten Email: send email Telefono: +43 512 9003 70070 Fax: +43 512 9003 73001	AT (INNSBRUCK)	participant	78˙705.36
20	MARTIN-LUTHER-UNIVERSITAET HALLE-WITTENBERG Organization address address: UNIVERSITAETSPLATZ 10 city: HALLE (Saale) postcode: 6099 contact info Titolo: Prof. Nome: Dan Cognome: Rujescu Email: send email Telefono: +49 3455573651	DE (HALLE (Saale))	participant	71˙900.40
21	UNIVERSITAETSKLINIKUM HEIDELBERG Organization address address: IM NEUENHEIMER FELD 672 city: HEIDELBERG postcode: 69120 contact info Titolo: Mr. Nome: Thorsten Cognome: Brietz Email: send email Telefono: +49 6221 567086 Fax: +49 6221 565460	DE (HEIDELBERG)	participant	71˙900.40
22	KATHOLIEKE UNIVERSITEIT LEUVEN Organization address address: Oude Markt 13 city: LEUVEN postcode: 3000 contact info Titolo: Dr. Nome: Elke Cognome: Lammertyn Email: send email Telefono: +32 16 32 06 21 Fax: +32 16 326515	BE (LEUVEN)	participant	22˙784.38
23	PSYCHIATRICKE CENTRUM PRAHA Organization address address: Ustavni 91 city: PRAHA postcode: 18103 contact info Titolo: Mr. Nome: Alexandr Cognome: Borovi?ka Email: send email Telefono: +420 266 003 400 Fax: +420 266 003 420	CZ (PRAHA)	participant	13˙172.40

Mappa

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impact treatment psychotic treatments basis optimization mri trials outcome patients drug markers goals anti imaging therapeutic guidelines functional prediction psychosocial choice experimental evidence deficits drugs cannabidiol schizophrenia strategies genetic interventions optimise determine cognitive clinical relapse first explore taken

Obiettivo del progetto (Objective)

'OPTiMiSE (OPtimization of Treatment and Management of Schizophrenia in Europe) will focus on two goals: optimising current treatments in Schizophrenia and explore novel therapeutic options for schizophrenia. The project intends to both address basic, but so far unanswered, questions in the treatment of schizophrenia and develop new and experimental interventions. It is expected that the project will lead to evidence that is directly applicable to treatment guidelines, will explore the development of novel treatments and will identify potential mechanisms for new drug development. To achieve these goals we have assembled a European team of experts that is second to none in the world. Together we will pursue the following objectives: -To use MRI to optimise treatment outcome and to facilitate prediction of response to treatment; - To provide a rational basis for antipsychotic choices in the treatment of first episode schizophrenia or schizophreniform disorder; - To improve functional outcome and reduce drug discontinuation by means of psychosocial interventions. - To explore the potential of cannabidiol CBD, a modulator of endocannabinoid functioning, as an alternative to D2 based antipsychotics - To validate a new approach to improve cognitive performance in patients with cognitive deficits on the basis of their genetic make up; - To use theoretically driven neurochemical imaging (MRS) and empirically driven genetic/genomic markers as predictors of response to treatment.'

Introduzione (Teaser)

A large European consortium is working to improve existing treatments for schizophrenia and implement new ones. Through clinical trials, the OPTIMISE study will determine treatment response, while novel imaging and biomarker tools will facilitate response prediction.

Descrizione progetto (Article)

The first drugs to treat schizophrenia were developed nearly 50 years ago and were designed to tackle the psychotic episodes of patients. Although in most instances these drugs have proved efficacious in treating psychosis, their overall functional impact is limited. As a result, patients suffer from cognitive deficits and those who discontinue the drugs quickly relapse.

In order to improve current treatment strategies, the EU-funded 'Optimization of treatment and management of schizophrenia in Europe' (http://www.optimisetrial.eu/ (OPTIMISE)) project will perform clinical trials. At the same time, it will test novel therapeutics in a series of experimental studies.

Treatment optimisation is based on concomitant examination of patients with magnetic resonance imaging (MRI) for the detection of any underlying pathological aetiology. The idea is that patients with pathophysiological causes should not receive anti-psychotic drugs. MRI, alongside proteomics and metabolomics markers, will also be used to assess how patients respond to treatment. Taken together, this information will determine the predictive role of MRI and molecular analysis.

An important part of OPTIMISE work is to provide evidence for the choice of anti-psychotic treatments. For this purpose, partners will evaluate if amilsulpride is a justified first-choice drug and what course of action should be taken for patients who fail to respond. Administration of clozapine will be assessed in this context.

In order to improve the functional outcome of existing treatments, the consortium will test the impact of various psychosocial interventions. Furthermore, novel therapeutic strategies such as cannabidiol will be evaluated. The trial protocols have been established and approved, and partners are in the process of recruiting patients.

The outcome of the OPTIMISE trials will significantly impact current diagnostic and therapeutic practice in schizophrenia. These evidence-based treatment guidelines are expected to improve treatment responses, while the psycho-educational package will improve adherence and prevent relapse.