Voditelj:
Prof.dr.sc. Neven Henigsberg
Hrvatski institut za istraživanje mozga
Šalata 12, 10000 Zagreb

Odsjek za psihofarmakologiju i neurobiologiju ponašanja je posvećen etičkoj studiji i sudjelovanju u pronalaženju novih lijekova za psihijatrijske poremećaje kroz klinička istraživanja. Ciljevi Odjela su da stimulira kvalitetu kliničkih ispitivanja, da usmjeri istraživačke procese, od dizajna do objavljivanja protokola, te da educira istražitelje o dobroj kliničkoj praksi, regulatornim pitanjima i menadžmentu. Hrvatski institut za istraživanje mozga (HIIM) je osnovao Institucionalni odbor za recenziju svih predloženih istraživanja na ljudima kako bi se osiguralo da ispitanici i njihova prava i dobrobiti budu adekvatno zaštićeni. Odsjek za psihofarmakologiju i neurobiologiju ponašanja je multidisciplinarna skupina, koja je uključena u integrativna neuroznanstvena istraživanja moždanih mehanizama psihijatrijskih poremećaja. Odjel je odgovoran za istraživanje, obrazovanje i liječenje koje uključuje kliničku psihofarmakologiju, ali nije samo na nju ograničeno. Danas je HIIM poticajno okruženje u kojem akademska istraživanja i nastava dolaze zajedno kako bi unaprijedili znanje o terapijskim mogućnostima u duševnim smetnjama. Glavna snaga HIIM-a je kapacitet za proučavanje mozga pomoću kombiniranih perspektiva - kliničkih i temeljnih istraživanja. Ovo istraživačko okruženje aktivno potiče suradnju između istraživača koji imaju različita područja stručnosti. Više od 50 članova nastavnog osoblja pridonose svojim istraživačkim i kliničkim kapacitetom u multidisciplinarnim timovima. Studije na ljudima koriste bihevioralnu, spoznajnu, i elektrofiziološku metodologiju, kao i slikovni prikaz mozga.

ORGANIZACIJA

Odsjek za psihofarmakologiju i neurobiologiju ponašanja funkcionalno je integriran s Odjelom za kliničko ispitivanje Poliklinike "Neuron", zdravstvenoj ustanovi koja pruža usluge specijalista u svim srodnim područjima poremećaja centralnog živčanog sustava. Osim svojih obveza pri HIIM-u, istraživači su svojim istraživanjima povezani sa svim sveučilišnim zavodima i klinikama. U cilju promicanja integrativne suradnje između najpriznatijih institucija u kliničkim istraživanjima, Odsjek koordinira "Mrežu kliničkih istraživanja pri HIIM-u", kao multi-partnersku inicijativu za promicanje kliničkih istraživanja u Hrvatskoj, izgradnjom istraživačke infrastrukture i profesionalnih resursa, te pojednostavljenjem upravljanja i regulatornih procesa. Četiri vodeće institucije pridružile su se Mreži, s ukupnim kapacitetom od 2.000 bolničkihkreveta, što predstavlja znatan potencijal za brzu aktivaciju istraživanja u gotovo svakom području vezanom za središnji živčani sustav, a s ciljem poboljšanja brzine, kvalitete i integracije kliničkih istraživanja.

ZNANSTVENI INTERESI

Znanstveni interesi Odjela su uglavnom usmjereni na: 1. Prepoznavanje neurobioloških prediktora, kao i parametara u slikovnom prikazu mozga za učinkovitost i sigurnosti psihoaktivnih lijekova; 2. Sudjelovanje u razvoju genomske terapije u depresiji, shizofreniji i progresivnoj demenciji. Kao jedino kliničko mjesto izvan zemalja Europske unije, Odsjek za psihofarmakologiju i neurobiologiju ponašanja, sudjelovao je u razdoblju između 2004. i 2008. kao punopravni član Europske komisije u znanstvenom projektu " Genomic- based therapies for depression /GENDEP/“, financiranom putem FP6, koji je uključivao 12 kliničkih centara u 9 europskih zemalja. Poštujući sva etička načela, znanstvena ispitivanja u psihijatrijskoj genetici dodatno su osnažena suradnjom s Hrvatskim zavodom za javno zdravstvo, koji održava jedan od najstarijih registara psihijatrijskih bolesnika u Europi.

SURADNJA S INDUSTRIJOM

Istraživači s Odsjeka imaju više od 70 multicentričnih, međunarodnih kliničkih ispitivanja te proučavaju mnoge nove metode liječenja koje će se naknadno odobriti za kliničku primjenu kako u djece, odraslih i adolescenata, tako i u gerijatrijskoj populaciji s dijagnozom različitih duševnih smetnji. Odsjek za psihofarmakologiju i neurobiologiju ponašanja nudi svojim partnerima niz usluga vezanih uz regulatornu prijavu ispitivanja, njegovo izvođenje i praćenje, uključujući: izradu izvješća i ostale potrebne dokumentacije regulatornim tijekima,

• Razvoj protokola u kliničkim ispitivanjima
• Pregled izvedivosti novih studija
• Odgojno-obrazovne mogućnosti za kliničke istražitelje i koordinatore
• Koordinacija i izvođenje kompletnih studija,
• Kompletna klinička, laboratorijska i tehnička podrška, uključujući i pripremu uzoraka, obradu i dostavu
• Računalno upravljanje i vođenje ispitivanja
• Analiza podataka i izrada izvješća pojedinih studija i meta-analize kliničkih ispitivanja
• Farmakoekonomske analize
• Edukacija pacijenata
• Odsjek jamči osiguranje kvalitete,s ciljem jačanja i poštivanja dobre kliničke prakse i zakonskih zahtjeva u vođenju ispitivanja.

BUDUĆI RAZVOJ

Integracija kliničke psihofarmakologije s predkliničkom psihofarmakologijom istraživanja predstavlja jedan od glavnih interesa istražitelja unutar Odsjeka. Istraživači imaju veliko iskustvo u ranim fazama razvoja lijekova. Opseg kliničkih istraživanja na HIIM-u širi se na rane faze kliničkih ispitivanja i razvoj lijekova. Cilj je daljnje jačanje već postojećih farmakogenetičkih istraživanja pri HIIM-u s drugim skupinama u Hrvatskoj, koje uključuju vodeće istraživače u psihijatriji, molekularnoj genetici, slikovnom prikazu mozga, anatomiji i molekularnoj biologiji.

Head:
Prof. Neven Henigsberg, MD, PhD
Croatian Institute for Brain Research
Šalata 12, HR-10000 Zagreb

The Department of Psychopharmacology and Neurobiology of Behaviour is dedicated to ethical studies and participation in finding new drugs for psychiatric disorders through clinical trials. The goals of the Department are the stimulation of the quality of clinical trials, directing the research processes from design to protocol finalization and education of researchers about Good clinical practice in regulatory issues and management. Croatian Institute for Brain Research (CIBR) has founded The Institutional Board for the review of all proposed research on humans as to ensure the adequate protection of research subjects, their rights and their well-being. The Department for Psychopharmacology and Neurobiology of Behaviour is a multidisciplinary team that is involved in integrative neuroscientific research of brain mechanisms of psychiatric disorders. The Department is responsible for research, education and treatment which includes clinical psychopharmacology but is not limited to it.
Today, CIBR is a stimulating environment in which academic research and teaching come together to advance the knowledge about therapeutic possibilities in mental disorders. CIBRS’s main strength is the capacity to study brain through combined perspectives – clinical and basic research. This research environment actively encourages collaboration between researchers of different areas of expertise. More than 50 members of teaching staff contribute with their research and clinical capacity in multidisciplinary teams. Studies conducted on humans utilise behavioural, cognitive and electrophysiological methodology, as well as brain imaging techniques.

ORGANIZATION

The Department of Psychopharmacology and Neurobiology of Behaviour is functionally integrated with the Department for Clinical Trials of Polyclinic “Neuron”, medical institution which provides the services of the specialists related to central nervous system disorders. The researchers are associated to all university departments and clinics, as well as CIBR. Aiming to promote integrative cooperation between most recognized institutions in clinical trials, the Department is coordinating “The Network of Clinical Trials at CIBR” as a multi-partner initiative for promoting clinical trials in Croatia by establishing research infrastructure and professional resources together with the simplification of governing and regulatory processes. Four of the leading institutions have joined The Network with the combined capacity of almost 2000 hospital beds which represents considerable potential for quick activation of research in almost every area related to central nervous system, with the aim to improve the rate, quality and integration of clinical trials.

SCIENTIFIC INTERESTS

Scientific interests of the Department are mostly related to:
1. Recognising neurobiological predictors and parameters in brain imagining for the effectiveness and the safety of psychoactive drugs.
2. Participation in the development of the genome therapy in depression, schizophrenia and progressive dementia. From 2004 to 2008, The Department of Psychopharmacology and Neurobiology of Behaviour participated, as the only clinical centre outside of the European Union, as a full member in the European Commission with the scientific project "Genomic- based therapies for depression /GENDEP/“, FP6 financed, which included 12 clinical centres in 9 European countries. Complying with all ethical principles, scientific research in psychiatric genetics is further strengthened in collaboration with Croatian Institute for Public Health which holds one of the oldest registers of psychiatric patients in Europe.

COLABORATION WITH THE INDUSTRY

• The researchers from the Department have performed more than 70 multicentre, international clinical trials studying new methods of treatments which will subsequently be approved in clinical application in child, adolescent, adult and the geriatric population with the diagnoses of different mental disorders. The Department of Psychopharmacology and Neurobiology of Behaviour offers its partners a variety of services related to regulatory application of clinical trials, clinical trial conduction, as well as:
• Development of reports and other necessary documentation for regulatory bodies
• The development of the protocol in clinical trials
• Feasibility studies
• Educational possibilities for investigators and coordinators in clinical trials
• Coordination and performance of complete studies
• Complete clinical, laboratory and technical support, including the preparation, analysis and delivery of samples
• Computer management and conduction of the trial
• Data analysis and development of reports and meta-analysis of clinical trials
• Pharmaco-economic analysis
• Education of patients
• The Department guarantees quality assurance aiming to strengthen and comply with Good Clinical Practice and the legislative demands in conduction of clinical trials

FUTURE DEVELOPMENT

The integration of clinical psychopharmacology with the preclinical psychopharmacology research presents one of the main interests within the Department. The researchers have vast experience in early phases of drug development. The span of clinical research in CIBR is expanding to early phases of clinical trials and drug development. The aim is to further strengthen the already existing pharmacogenetic research in CIBR with the other groups in Croatia which include the leading researchers in psychiatry, molecular genetics, brain imaging, anatomy and molecular biology.

IZABRANE PUBLIKACIJE / SELECTED PUBLICATIONS:

• Sarac H, Henigsberg N, Markeljević J, Pavlisa G, Hof PR, Simić G. Fragile X-premutation tremor/ataxia syndrome (FXTAS) in a young woman: clinical, genetics, MRI and 1H-MR spectroscopy correlates. Coll Antropol. 2011 Jan;35 Suppl 1:327-32. PubMed PMID: 21648356.
• Radonić E, Rados M, Kalember P, Bajs-Janović M, Folnegović-Smalc V, Henigsberg N. Comparison of hippocampal volumes in schizophrenia, schizoaffective and bipolar disorder. Coll Antropol. 2011 Jan;35 Suppl 1:249-52. PubMed PMID: 21648342.
• Loncar M, Plasć ID, Bunjevac T, Henigsberg N, Hrabac P, Groznica I, Marcinko V, Jevtović S. Self-assessment of well-being as an indicator of quality of life of former war prisoners - A Croatian study. Coll Antropol. 2011 Jan;35 Suppl 1:199-204. PubMed PMID: 21648334.
• Henigsberg N, Kalember P, Hrabać P, Rados M, Bajs M, Rados M, Kovavić Z, Loncar M, Madzar T. 1-H MRS changes in dorsolateral prefrontal cortex after donepezil treatment in patients with mild to moderate Alzheimer's disease. Coll Antropol. 2011 Jan;35 Suppl 1:159-62. PubMed PMID: 21648328.
• Henigsberg N, Bajs M, Hrabac P, Kalember P, Rados M, Rados M, Radonić E. Changes in brain metabolites measured with magnetic resonance spectroscopy in antidepressant responders with comorbid major depression and posttraumatic stress disorder. Coll Antropol. 2011 Jan;35 Suppl 1:145-8. PubMed PMID: 21648325.
• Plasć ID, Poljarević S, Loncar M, Henigsberg N. Age-developmental stage and severity of trauma related symptoms, anxiety and depressive symptoms in participants who lost their fathers during the war in Croatia. Coll Antropol. 2011 Jan;35 Suppl 1:139-44. PubMed PMID: 21648324.
• UherR, DernovsekMZ, MorsO, HauserJ, SoueryD, ZobelA, MaierW, Henigsberg N, Kalember P, Rietschel M, Placentino A, Mendlewicz J, Aitchison KJ, McGuffin P, Farmer A. Melancholic, atypical and anxious depression subtypes and outcome of treatment with escitalopram and nortriptyline. J Affect Disord. 2011 Jul;132(1-2):112-20. Epub 2011 Mar 15. PubMed PMID: 21411156.
• Strohmaier J, Wüst S, Uher R, Henigsberg N, Mors O, Hauser J, Souery D, Zobel A, Dernovsek MZ, Streit F, Schmäl C, Kozel D, Placentino A, Farmer A, McGuffin P, Aitchison KJ, Rietschel M. Sexual dysfunction during treatment with serotonergic and noradrenergic antidepressants: Clinical description and the role of the 5-HTTLPR. World J Biol Psychiatry. 2011 Mar 9. [Epub ahead of print] PubMed PMID: 21388237.
• Malki K, Uher R, Paya-Cano J, Binder E, Rietschel M, Zobel A, Mors O, Hauser J, Henigsberg N, Jerman B, Souery D, Placentino A, Ng MY, Cohen-Woods S, Sluyter F, Farmer A, Aitchison KJ, Craig IW, Lewis CM, McGuffin P, Schalkwyk LC. Convergent animal and human evidence suggests a role of PPM1A gene in response to antidepressants. Biol Psychiatry. 2011 Feb 15;69(4):360-5. Epub 2010 Oct 20. PubMed PMID: 20970119.
• Perroud N, Uher R, Ng MY, Guipponi M, Hauser J, Henigsberg N, Maier W, Mors O, Gennarelli M, Rietschel M, Souery D, Dernovsek MZ, Stamp AS, Lathrop M, Farmer A, Breen G, Aitchison KJ, Lewis CM, Craig IW, McGuffin P. Genome-wide association study of increasing suicidal ideation during antidepressant treatment in the GENDEP project. Pharmacogenomics J. 2011; 11(2): 138-4. PubMed PMID: 20877300.