INFORMED CONSENT IN PSYCHIATRIC RESEARCH – CONCEPTS AND CHALLENGES

Research involving vulnerable population of mentally impaired persons is raising considerable controversies from its very beginnings. These controversies are created around everlasting tensions between two positive duties: the duty to protect vulnerable subjects, and the duty not to deny them potential benefits. Most of the contemporary ethical guidelines and regulations, including most recent revision of the Declaration of Helsinki, permit these researches under certain ethical conditions. The notion of informed consent as a cornerstone of bioethics emerges as essential requisite of moral research. We are presenting some key concepts and safeguards regarding informed consent that researcher needs to be aware off when conducting a research involving mentally impaired persons. Theoretical and practical challenges that are arising from these safeguards are discussed with an overview of most recent scientific data. Lastly, we briefly address the most important legal standings that will be introduced in 2015, by new Croatian Law on the Protection of Persons with Mental Disorders

The relationship between depressive syndrome and suicidal risk in patients with acute schizophrenia

Aim To determine the relationship between scores on five factors of the Positive and Negative Syndrome Scale (PANSS) and Calgary Depression scale for Schizophrenia (CDSS) and scores on the InterSePT Scale for Suicidal Thinking (ISST) in patients with acute schizophrenia. Methods Data were collected on sociodemographic and clinical characteristics of 180 drug-treated in-patients with acute schizophrenia. Their symptoms were assessed with PANSS, CDSS, and ISST and correlations between the scores were calculated. Statistically significant correlations were included in the logistic regression analysis to identify predictors of suicidal risk. Results CDSS (P < 0.001) score and negative (P < 0.001), disorganized (P = 0.041), emotional (P < 0.001), and total score on PANSS (P < 0.001) showed a significant positive correlation with ISST. Stepwise logistic regression analysis revealed that CDSS scores (odds ratio [OR] 5.18; confidence interval [CI] 1.58-16.95), and disorganized (0.90; 0.81-0.99) and emotional (1.15; 1.01-1.30) factors of PANSS were predictors of suicidal risk. Conclusion Our results suggested a considerable association between depressive syndrome as assessed by the PANSS emotional factor and CDSS score and suicidal risk in patients with acute schizophrenia

Two-year Rehospitalization Rates of Patients with Newly Diagnosed or Chronic Schizophrenia on Atypical or Typical Antipsychotic Drugs: Retrospective Cohort Study

Cilj Odrediti smanjuju li atipični antipsihotički lijekovi stopu rehospitalizacije bolesnika s novodijagnosticiranom ili kroničnom shizofrenijom više nego tipični lijekovi. Postupci Od 1. siječnja 2003. do 31. prosinca 2004. retrospektivno smo uspoređivali dvogodišnje stope rehospitalizacije 135 bolesnika s novodijagnosticiranom i 398 bolesnika s kroničnom shizofrenijom (62%, odnosno 65% muškaraca) koji su otpušteni s liječenja u Psihijatrijskoj bolnici Vrapče u Zagrebu u razdoblju između 1. siječnja 2002. do 31. prosinca 2002. a bili su im prepisani atipični (olanzapin, risperidon ili klozapin) ili tipični (haloperidol ili flufenazin) antipsihotici. Vrijeme do ponovnog primanja u bolnicu određeno je Kaplan-Meierovom formulom za analizu preživljenja. Rezultati Za vrijeme dvije godine koliko je trajalo praćenje rehospitalizirana su 52 (39%) bolesnika s novodijagnosticiranom i 197 (47%) bolesnika s kroničnom shizofrenijom. Nije bilo značajnih razlika u vremenu do rehospitalizacije s obzirom na vrstu uzimanog lijeka između bolesnika s novodijagnosticiranom (P=0,378) i bolesnika s kroničnom shizofrenijom (P=0,531). Zaključak. Stopa rehospitalizacije u bolesnika kojima su prepisani atipični antipsihotici bila je slična stopi u bolesnika kojima su prepisani tipični antipsihotici i za bolesnike s novodijagnosticiranom i za bolesnike s kroničnom shizofrenijom.Aim To determine if atypical antipsychotic agents reduce the rehospitalization rates of patients with newly diagnosed or chronic schizophrenia in comparison with typical antipsychotic drugs. Methods From January 1, 2003, to December 31, 2004, we retrospectively compared two-year rehospitalization rates of 135 patients with newly diagnosed schizophrenia and 398 patients with chronic schizophrenia (62% and 65% men, respectively), who were initially discharged from Vrapče Psychiatric Hospital, Zagreb, with the prescription of atypical (olanzapine, risperidone or clozapine) or typical (haloperidol or fluphenazine) antipsychotic treatment between January 1, 2002 and December 31, 2002. Time-to-readmission was determined with Kaplan-Meier formula for survival analysis. Results In the two-year follow-up, 52 (39%) newly diagnosed patients and 197 (47%) patients with chronic schizophrenia were rehospitalized. No significant differences in time-to-rehospitalization were observed with respect to the type of medications in patients with newly diagnosed schizophrenia (P = 0.378) or patients with chronic schizophrenia (P = 0.531). Conclusions. Rehospitalization rates of patients who were prescribed atypical antipsychotic drugs were similar to those of patients who were prescribed typical antipsychotic drugs for both the group with the first psychotic episode and group with chronic schizophrenia

Usporedba depresivnoga i demoralizacijskoga sindroma kao predskazatelja suicidalnosti u kroničnoj fazi shizofrenije

The aim of this study was to evaluate the impact of depression and demoralization syndromes on suicidality in patients with chronic schizophrenia. Methods: A prospective study on 146 out-patients with chronic schizophrenia, treated in Psychiatric University Hospital “Vrapče”, Zagreb, Croatia, from April 15th 2011 to June 1st 2013. Every patient’s schizophrenia diagnosis was independently made by two psychiatrists, using ICD-10 and DSM-IV criteria. Sociodemographic, clinical and hospital data were collected for every patient. Severity of their symptoms was assessed with the Positive and Negative Syndrome Scale (PANSS), the Calgary Depression Scale for Schizophrenia (CDSS), the InterSePT Scale for Suicidal Thinking (ISST) and the self-administered Demoralization Scale (DS). Statistical analysis included descriptive statistics, chi-square, Wilcoxon test and McNemar test. Spearman's rank correlation coefficient were calculated to identify and test the strength of relationship between scores on used scales while the multiple regression model was used to test multivariate predictive models of suicidality. Results: The statistically significant positive correlations were found between patient’s demoralization categories and their male sex, number of previous hospitalizations (second test), hereditary of suicidality, CDSS score, ISST score and scores on cognitive, affective and negative factors of the PANSS. The statistically significant positive correlation were found between patient’s depression categories and their heredity of suicidality, number of previous hospitalizations, DS score, as well as scores of cognitive, affective and negative factors of the PANSS. Suicidality had statistically significant positive correlation with patient’s male sex, heredity of suicidality, number of previous hospitalizations, DS score, CDSS score and scores of cognitive, affective and negative factors of the PANSS. In the multiple regression model, two initial predictive variables had statistically significant association with suicidality: DS score and score of affective factor of the PANSS. In second test, two predictive variables showed statistically significant association with suicidality: DS score and CDSS score. Demoralization was stronger predictor than depression

ETHICAL OVERVIEW OF PLACEBO CONTROL IN PSYCHIATRIC RESEARCH - CONCEPTS AND CHALLENGES

Permissibility of placebo controls in psychiatric research is raising everlasting controversies. The main ethical issue remains: whether, when, under what conditions, and to what extent is it justifiable to disregard subject’s present (best) interest for the presumably "greater" ones. In relation to this main ethical concern, two distinct arguments arose: proponents of placebo controls trials (placebo ortxodoxy) and proponents of active controls trials (active-control orthodoxy). More recently, in new ethical guidelines, Declaration of Helsinki and International Ethical Guidelines for Biomedical Research Involving Human Subjects, a "middle way" approach was formulated, acceptable to both sides of the argument, saying placebo controls can be justified under certain conditions: when and only when, they firstly present undisputed methodological reasoning, and secondly, fulfill certain ethical considerations – mainly regarding the permissibility of accompanied risks. These ethical evaluations are inevitably contextual and evoke the need for the principle of proportionality. In scope of recent findings of substantial and progressively increasing placebo response in psychiatric research, contextual factors are identified and both theoretical and practical challenges are discussed

Characteristics of Patients Who Committed Suicide during Hospitalization in Psychiatric Hospital »Vrap~e« in the Period 1996–2006

The aim of this study was to determine the characteristics of psychiatric inpatients who committed suicide in the Vrap~e Psychiatric Hospital with respect to clinical, ethical, and legal context. The study included all patients hospitalized in the Vrap~e Psychiatric Hospital between 1 January 1996 and 31 December 2006 who committed suicide (n=25). The suicide rate in the observed period was 32.9 per 100.000 (suicide coefficient, 50), which is similar that in general population. Based on the characteristics of hospitalized patients who committed suicide, we obtained a typical profile as follows: a middle-aged person, single, unemployed, repeatedly hospitalized, with schizophrenia and a history of suicide attempts, committing suicide using a violent method after more than three weeks of hospital treatment. If further prevention of hospital suicide will be treated as a legal rather than medical issue, the hospital atmosphere would be totalitarian rather than therapeutic. The success of psychiatric treatment is the perception of both of these aspects of suicide as well as their efficient balancing