Psychopharmaca in Law and Ethical Contexts

Psihofarmaci su lijekovi koji, uz svoje specifičnosti, trebaju biti posebno „tretirani“ zbog činjenice da su namijenjeni duševnim bolesnicima koji mogu biti u stanju nemogućnosti slobodnog opredjeljenja za uzimanje ili neuzimanje tih lijekova. Zbog toga je sve zakone i pravilnike koji se odnose na lijekove potrebno čitati i u kontekstu primjene psihofarmaka. U članku se navode najvažnije odrednice Zakona o lijekovima i medicinskim proizvodima, zatim Pravilnika o dobroj kliničkoj praksi, Pravilnika o postupku i načinu davanja odobrenja za stavljanje u promet gotovog lijeka, Pravilnika o praćenju nuspojava lijekova, Zakona o suzbijanju zlouporabe opojnih droga, Pravilnik o uvjetima i načinu postupanja s narkoticima i psihotropnim tvarima i Zakona o zaštiti osoba s duševnim smetnjama, koji imaju implikacije na postupanje s psihofarmacima. Na kraju se daju naznake etičkih problema vezanih uz primjenu psihofarmaka.Psychopharmaca are medications that, besides their own specificities, require special “treatment” due to the fact that they are designed for patients with mental disorders, who could be unable to deside freely whether to take them or not. Because of this, all the laws and regulations regarding drugs must be read also in the context of the application of psychopharmaca. In the article are listed the most important determinants of the law on drugs and medical products, and of the regulations of good clinical practice, the regulations of approval procedures for marketing of a new drug, the regulations of side effects follow-up, the law on suppressing abuse of narcotics, the regulations of conditions and ways of treating narcotics and psychotropic substances and the law on protection of persons with mental disorders, all having implications on treating psychopharmaca. Finally are given notes on ethical problems connected with their application

Pharmacoeconomics Investigation of Psychofarmacs

Gospodarske procjene posljedica narušenja mentalnog zdravlja i istraživanja u kojima se terapijski ishod uspoređuje s uloženim sredstvima sve se češće susreću u stručnoj i znanstvenoj literaturi, usporedno s porastom broja raspoloživih mogućnosti u farmakoterapiji psihijatrijskih poremećaja. U ovom je prikazu dan osvrt na važnija istraživanja ekonomskih posljedica psihijatrijskih poremećaja, kretanja u potrošnji psihofarmaka, načela provođenja farmakoekonomskih istraživanja te na mogućnost njihove primjene u praksi.Economic estimation of consequences of disturbed mental health and of research in which therapeutic outcome is compared with invested funds has often been met in professional and scientific literature, along with the increase of available possibilities in pharmacotherapy of psychiatric disorders. This review presents more important research work in economic sequelae of psychiatric disorders, trends in use of psychopharmaca, principles of conducting pharmacoeconomic investigations, and the possibilities of their practical application

SERUM BRAIN-DERIVED NEUROTROPHIC FACTOR (BDNF): THE SEVERITY AND SYMPTOMATIC DIMENSIONS OF DEPRESSION

Introduction: The aim of this study was to compare the concentration of serum Brain-derived neurotrophic factor (BDNF) in patients suffering from major depressive disorder (MDD) considering the severity of MDD episode defined by the Hamilton rating scale for depression (HAMD-17). The other aim was to research the connection between serum BDNF and the symptomatic dimensions of MDD. Subjects and methods: The study includes 139 participants with major depressive disorder (MDD). Diagnosis of MDD was set by DSM-IV-TR criteria. The severity of MDD was estimated with HAM-D-17 in the manner that mild episode was diagnosed if the score on HAMD-17 was up to 18, moderately severe 18-25 and severe over 25. Concentration of BDNF was determined by the ELISA method. Results: This research could not find a difference in BDNF concentration considering the severity of the depressive disorder in groups suffering from mild, moderately severe and severe episodes of MDD (F=1.816; p=0.169). Factor analysis of HAMD-17 extracted four dimensions of depressive symptoms. None of the symptomatic dimensions was significantly related to BDNF concentration. Conclusion: Results of this study indicate that serum BDNF levels are not related to the severity of depression and its specific symptomatic dimensions. These findings support the idea of a complex relationship between BDNF concentration at the periphery and in the CNS

New Evidence of Brick Production at Viminacium

During a few decades long period of excavations at Viminacium, a great number of brick kilns has been found, which testify of a highly developed industry of brick production at this site.The kilns have been mostly discovered at the territory of the southern city’s necropolis, at thePećine site, where a production center, consisting of three kilns with a shared porch, has beenexcavated. A lesser number of brick kilns has been found west and east of the city. During therescue excavations in 2017, relatively near to the site of this production center, a new brickkiln was uncovered. This newly found kiln represents one of the biggest and best preservedbrick kilns at Viminacium so far. The ring chamber, vaulted ring port and grill kiln have beenpreserved almost entirely and also the greatest part of the furnace chamber. In the layers with in the kiln, as well as in the construction itself, lots of bricks with the stamp of the VII Claudialegion and a few examples with this inscription in cursive writing have been found. Next to thekiln, a big pit has been excavated, which represents the mine for the extraction of clay used inthe brick-making. According to the small fnds, the kiln is dated to the 2nd century

Clinical Trials in Psychiatry

U članku su se pokušale razjasniti neke opće činjenice i noviji aspekti kliničkih ispitivanja. Klasifikacijski se klinička ispitivanja dijele na ona koja se baziraju na fazama kliničkog razvoja lijeka i na ona vezana uz tip i cilj studije. Između kliničkih ispitivanja po tipu ili po fazama postoji niz dodirnih točaka, ali i razlika. Unatoč sveprisutnom detaljnom obavještavanju bolesnika o ciljevima i načinima provođenja istraživanja te neovisnim ocjenama stručnih i etičkih načela u suvremenim istraživanjima i dalje je prisutno više etičkih dilema o provođenju kliničkih ispitivanja u psihijatriji.We have tried to explain some general facts and newer aspects of clinical trials. Clinical trials are classified as those based on the phases of clinical development of a particular drug and as those based on the type and goal of the trial itself. There are numerous contact points between trials according to type and according to phases, but differences exist as well. Despite the omnipresent detailed information to the patients about the aims and ways of performing the investigations, and independent evaluations by professional and ethical principles in current studies, several ethical dilemmas regarding the clinical trials performance in psychiatry are still present

COGNITIVE DEFICIT IN SCHIZOPHRENIA: AN OVERVIEW

Depressive mood, anxiety, delusions, hallucinations and behavioral disturbances have been traditionally recognized as leading symptoms of mental disorders. However, cognitive symptoms went under-recognized or declined. Today there is robust evidence that cognitive dysfunction is present in the majority of mental disorders and is also related to impairments in the functioning of the persons with mental illness. It is proposed that aberrant brain neuronal network connectivity, arising from interplay of genetic, epigenetic, developmental and environmental factors, is responsible for cognitive decline. In schizophrenia, dysfunctions in working memory, attention, processing speed, visual and verbal learning with substantial deficit in reasoning, planning, abstract thinking and problem solving have been extensively documented. Social cognition – the ability to correctly process information and use it to generate appropriate response in situations, is also impaired. The correlation of cognitive impairment with functional outcome and employment, independent living and social functioning has emphasized the need for development of the treatments specific to cognition. It is considered that brain neuroplasticity allows for re-modulating and compensating the impairment process which could give opportunity to improve cognitive functions. Therefore, there is a need for comprehensive clinical assessment and follow-up of cognitive decline in mental illness. Implementation of specific treatment strategies addressing cognitive decline in mental illness, like new drugs, distinct cognitive-behavioural therapy, psychoeducation, social skills training and remediation strategies should be strongly indorsed targeting recovery and reduction of disability due to mental illness

Self-Assessment of Well-Being as an Indicator of Quality of Life of Former War Prisoners – A Croatian Study

The impact of war on the population is vast, especially when it comes to those who were directly affected by war, among other things as concentration camp detainees. Because of the specific war experience of this population it is important to better understand the possible contribution of key socio-demographic variables, war traumatization and acute disturbances in mental health to their subjective assessment of their own well-being, which represents a psychological category and is based on a subjective assessment. The starting point is a theoretical precept according to which individual characteristics, together with war experience, can have repercussions on mental health, and eventually on the general well-being of an individual and their quality of life. The study comprised 184 participants who had given their informed consent for participation and filled out complete questionnaires. The participants were a convenience sample of male persons who had survived war captivity in the Homeland War in the period from 1991 to 1995. The study was conducted as part of the physical examinations at the University Hospital »Fran Mihaljevi}« in Zagreb. The data was collected using several self-evaluation measuring instruments one of which served to collect socio-demographic data, two to collect data on the participants’ mental health, one for the data on the participants’ combat and war experiences and one to assess the participants’ well-being. The data obtained suggest that only avoidance and arousal symptoms and psychosomatic difficulties are predictors of the well-being of persons who have experienced war captivit