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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

Bergen Psychosis Project 2

Awarded: NOK 6.6 mill.

The Bergen Psychosis Project 2 (BP2) is a prospective, randomized, controlled comparison of antipsychotic drugs amisulpride, aripiprazole, and olanzapine, conducted independently of the pharmaceutical industry. BP2 developed into a multi-centre study with sites in Bergen, Trondheim, Stavanger and Innsbruck (Austria), and therefore received the additional name of BP2/ the Bergen-Stavanger-Innsbruck-Trondheim (Best Intro)study. The Project follows patients with psychosis for 12 months with repeated assessments and tests. The inclusion started in 2012, and the last included participant had the visit in December 2017. The project is now in the analysis-phase, and the results of the primary outcomes, which are changes and differences among the study drugs, is expected to be published at the end of 2018/ early 2019. Several other articles are underway or under submission. The Project has been presented in national media including the Bergens Tidende http ://www.lmi.no/media/2823249/bt_040312.pdf and NRK Kveldsnytt http://tv.nrk.no/serie/kveldsnytt/nnfa23051913/19-05-2013.

Man har gjennomført en legemiddelutprøving uavhengig av legemiddelindustri/ kommersielle aktører i form av en multisenterstudie, der også et ledende europeisk psykoseforskningsmiljø har deltatt aktivt. På nasjonalt nivå har man gjennom studien etablert et nettverk og en infrastruktur for gjennomføring av nye uavhengige legemiddelstudier. Videre har forskergruppen blitt invitert inn i sentrale europeiske forskningsnettverk og -studier. Man har også gjennomfør prosjektets translasjonelle elementer, det vil si samtidig repetert registrering av kliniske, kognitive, molekylære og hjerneavbildningsmål. Siden juli 2018 er forskergruppen ny partner i SFF NORMENT, med ansvar for farmakologi og intervensjonsforskning. En rekke artikkelprosjekter er under ferdigstilling basert på innsamlede data.

Currently it is not possible to predict which antipsychotic drug will be optimal with regards to effects and side effects for a patient with psychosis. In the Bergen Psychosis Project 2 (BP2) the first-line antipsychotic drugs AMISULPRIDE, ARIPIPRAZOLE an d OLANZAPINE will, independently of the pharmacoindustry, be compared head-to-head in a randomized, pragmatic effectiveness trial with a 12-months follow-up for the first time. The main objectives are to compare effects and side effects in a clinically re levant sample with schizophrenia spectrum and delusional disorders including also patients with comorbid substance abuse in order to establish which should be the preferred antipsychotic agent. The BP2 has also a strong translational emphasis with repeat ed measurements at the same time points of clinical variables, neurocognitive functioning, gene expression, gene products, and functional and structural MRIs. About half of the patients are expected to be drug-naïve at baseline making pre-treatment invest igations and repeated assessments feasible in a substantial proportion. The distinctly different receptor affinities of the drugs facilitate a translational approach whereby different drug effects on the molecular, functional, and structural levels can be associated with specific symptoms and functioning in the search for critical biological substrates of psychosis and drug effects. The results are expected to unveil mechanisms of etiological significance in psychosis and pave the way for a more targeted pharmacotherapy. Patients will be recruited consecutively in three major sites with a joint catchment population of 1,4 million inhabitants: the catchment areas of the Haukeland University Hospital and the St. Olavs Hospital, Trondheim University Hospita l, Norway; and the Medizinische Universität, Innsbruck, Austria, thus facilitating both national and international cooperation with one of the leading European schizophrenia research groups.

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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering