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To investigate the risk factors for and the consequences (ie, substance use disorders (SUD), depression, personality traits) of traumatic brain injury (TBI) in young Swiss men.This is a three-wave cohort study. Risk factors were measured at baseline (2010-2012) and at follow-up 1 (FU1; 2012-2014), while the consequences and TBI were measured at follow-up 2 (FU2; 2016-2018).Switzerland.All participants at FU2 (Mage=25.43, SD=1.25) of the Cohort Study on Substance Use Risk Factors (N=4881 young Swiss men after listwise deletion).The outcomes measured were TBI, SUD (ie, alcohol, nicotine, cannabis, other illicit drugs), depression and personality traits (ie, sensation seeking, anxiety-neuroticism, sociability, aggression-hostility) at FU2. The predictors were previous TBI (lifetime TBI but not in the past 12 months at FU2), SUD, personality traits and sociodemographics (highest level of achieved education, age, linguistic region) measured at FU1.At FU2, 3919 (80.3%) participants reported to never have had TBI, 102 (2.1%) have had TBI in the last 12 months (TBI new cases), and 860 (17.6%) have had TBI during their lifetime but not in the 12 months preceding FU2 (previous TBI). Low educational attainment (OR=3.93, 95% CI 2.10 to 7.36), depression (OR=2.87, 95% CI 1.35 to 6.11), nicotine dependence (OR=1.72, 95% CI 1.09 to 2.71), high sociability (OR=1.18, 95% CI 1.07 to 1.30), high aggression-hostility (OR=1.15, 95% CI 1.06 to 1.26) and high sensation seeking (OR=1.33, 95% CI 1.04 to 1.68) at FU1 were significantly associated with TBI new cases at FU2. Previous TBI was significantly associated with nicotine dependence (OR=1.46, 95% CI 1.16 to 1.83), depression (OR=2.16, 95% CI 1.56 to 2.99) and aggression-hostility (B=0.14, 95% CI0.00 to 0.28) at FU2.Low educational attainment and depression are the most significant risk factors associated with increased odds of future TBI, while depression, nicotine dependence and high aggression-hostility are the main consequences of previous TBI. TBI should be considered an underlying factor in the treatment of depression, SUD or unfavourable personality profiles.

Valentin Matei,1,2 Alexandru Pavel,1,2 Ana Giurgiuca,1,2 Alina Roșca,1,2 Arina Sofia,1,2 Irina Duțu,1,2 Cătălina Tudose1,2 1Psychiatry Department, University of Medicine and Pharmacy “Carol Davila”, Bucharest, Romania; 2 2nd Clinical Ward, “Prof. Dr. Alexandru Obregia” Psychiatric Hospital, Bucharest, RomaniaCorrespondence: Alexandru Pavel Email alexnpavel@yahoo.comPurpose: Patients with severe mental illness (SMI) and alcohol use disorder (AUD) are at higher risk for contracting coronavirus-19 (COVID-19) and for poor outcomes of COVID-19 infection. One reason for this could be the lack of knowledge regarding preventive measures against COVID-19 and the inability of the psychiatric patients to discern misinformation from facts.Patients and Methods: The study design was cross-sectional. We applied one questionnaire that evaluated knowledge of prevention measures and information about COVID-19 (comprised of two sections, each with five questions). The first section evaluated knowledge regarding the official WHO prevention measures against COVID-19, and the second consisted of false information about COVID-19 which examined the ability to identify misinformation about COVID-19. These questionnaires were applied face-to-face to psychiatric male inpatients from a tertiary psychiatric hospital in Bucharest diagnosed with SMI or severe alcohol disorder (SAUD) and to male controls from the community, matched by age and education. Mean scores of patients and controls were compared using Mann–Whitney test.Results: There were 115 male psychiatric patients in total (65 SMI and 50 SAUD) and 57 controls included after the matching procedure. We found statistically significant lower (P< 0.05) scores for psychiatric patients compared to controls regarding the prevention and general knowledge of COVID-19 (P< 0.001), the WHO information about prevention measures (P=0.041), and the ability to identify misinformation about COVID-19 (P< 0.001). The fact that psychiatric patients have less knowledge about prevention measures against COVID-19 and a reduced capacity to discern misinformation suggests that we need to identify new methods to convey correct information to these patients and also to better equip them to handle misinformation regarding COVID-19.Conclusion: Patients with SMI and SAUD are less informed regarding COVID-19 infection and preventive measures compared to controls, while being prone to believing false information about COVID-19 as well.Keywords: coronavirus, COVID-19, severe mental illness, alcohol use disorder

Valentin Petre Matei,1 Alexandra Ioana Mihăilescu,1,2 Iuliana Raluca Gheorghe,3 Ruxandra Grigoraş,4 Andrei Crasan,5 Alina Roșca,1,6 Ovidiu Popa-Velea2 1Clinical Hospital of Psychiatry “Alexandru Obregia”, Bucharest, Romania; 2Department of Medical Psychology, Faculty of Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania; 3Department of Marketing and Medical Technology, Faculty of Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania; 4Voila Psychiatric Hospital, Câmpina, Romania; 5The City Hospital of Curtea De Argeş, Curtea De Argeș, Romania; 6Department of Psychiatry, Faculty of Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, RomaniaCorrespondence: Iuliana Raluca Gheorghe Email raluca.gheorghe@umfcd.roPurpose: This study examined the validity of subjective clinical prognosis (SCP), a commonly used clinical tool, in first episode psychosis patients included in the European First Episode Schizophrenia Trial (EUFEST) study.Patients and Methods: The study comprised 455 patients from the EUFEST trial (mean age 25.92, SD=5.45; 188 (41.31%) women, 267 (58.69%) men). SCP was classified into three mutually exclusive groups: “good prognosis” (GP) (n=265), “average prognosis” (AP) (n=131), and “poor prognosis” (PP) (n=59). The validity of the SCP was assessed by investigating the differences between the SCP groups and completer or responder status of the patients, during 1 year of the trial.Results: The proportion of completers was significantly higher in the GP group (64.4%) compared to the AP group (25.6%) (OR=1.62, 95% CI=1.062– 2.476, p< 0.031) and the PP group (10%) (OR=2.17, 95% CI=1.226– 3.853, p< 0.009) throughout the whole duration of the trial. In what concerns responsiveness, a significantly higher number of responders were registered in the GP group compared to the AP and the PP groups in the first three months of treatment, but this outcome did not persist afterwards.Conclusion: In terms of its predictive value at first episode schizophrenic patients, SCP seems to be reliable for treatment completion, but has a limited utility in what concerns responsiveness to treatment. This finding suggests the necessity of creating a prediction model potentially including, besides SCP, other measurement-based variables.Keywords: anti-psychotics, first episode psychosis, prognosis, schizophrenia

Romania has been a member of the European Union since 2007. According to the World Health Organization, the national burden of mental disorders is high, with 2743.69 disability-adjusted life years per 100.000 population. Moreover, in a country of 19 million people, Romania's mental health system is currently functioning at capacity, with 5.66 adult psychiatrists/100.000 population and only 0.56 child and adolescent psychiatry (CAP) doctors per 100.000 population.we conducted a simple narrative review of the current literature on the topic of training of psychiatry trainees in Romania.Undergraduate training consists of only 4 weeks of clinical and theoretical work for adult and CAP. Psychiatry postgraduate training lasts 5 years and is still duration-oriented. Psychiatric trainees mostly spend their clinical work in inpatient units due to the scarcity of other services or the lack of integration of training programs in the existing psychiatric services. Theoretical training is not nationally formalized, and, during training, yearly assessments tend to be neglected. An ongoing challenge in Romania has been retaining young career psychiatrists.Although in a trend toward improvement of health services, "brain drain" has been and continues to be a massive phenomenon among Romanian psychiatrists, mainly driven to Western-European countries due to financial reasons, various shortcomings in overall infrastructure, and because of the lack of continuous professional and personal development opportunities. As the world is currently facing an unprecedented mental health crisis, steps must be taken to improve psychiatric training, retain psychiatrists in Romania, and provide better national mental health services.

Two previous randomized controlled trials (RCTs) suggested that adjunctive aspirin is efficacious in treating schizophrenia. We conducted two 16-week double-blind randomized placebo-controlled RCTs of adjunctive 1000 mg aspirin vs placebo in schizophrenia. Study 1 included 200 patients, with Positive and Negative Syndrome Scale (PANSS) total score as the primary outcome. Study 2 included 160 patients with C-reactive protein (CRP) >1 mg/L at baseline; the primary outcome was PANSS-positive score. Dropout rates for aspirin/placebo were 12% in study 1 and 20% in study 2. Differences in outcome between aspirin and placebo were calculated with linear regression, adjusting for the baseline value of the outcome. No statistically significant between-group differences were found in primary or secondary outcomes in either study. Study 1: mean difference in PANSS at 16 weeks was −3.9 (95% CI: −8.4 to 0.5, P = .10, effect size (ES) = −0.25) and at 8 weeks was −3.5 (95% CI: −7.5 to 0.5, P = .11, ES = −0.22). Study 2: mean difference in PANSS at 16 weeks was 0.3 (95% CI: −4.1 to 4.7, P = .90, ES = 0.02) and in positive PANSS was 0.5 (95% CI: −1.0 to 2.1, P = .50, ES = 0.11). A meta-analysis of these data with the existing studies, excluding one with large baseline differences in total PANSS, found that the overall estimate of the effect of adjunctive aspirin on the PANSS total score comparing group means at the end of the study was −2.9 (95% CI: −6.6 to 0.7; P = .21), favoring aspirin. Our studies and meta-analysis failed to find a statistically significant improvement in the symptoms of schizophrenia from adjunctive aspirin therapy in comparison to placebo in schizophrenia. Trial registration: study 1: Clinicaltrials.gov: NCT01320982; study 2 (high CRP): EudraCT Number: 2014-000757-36.

Context The immune system has an important role in the etiology of depression, through the pro-inflammatory cytokines and acute phase protein mechanisms. In elderly people, frequent association between depression and medical conditions leads to a difficult psychiatric diagnosis, becoming necessary to determine a specific biological marker for this category of population. C-Reactive Protein (CRP) did not prove to have a high level of validity, but higher levels of high-sensitivity C-Reactive Protein (hs-CRP) were found to be associated both with cardiovascular disease and depressive disorder, through a bidirectional relationship. Objectives To investigate the possible association between a major depressive episode and levels of inflammatory markers among a population of elderly. Subjects and methods A prospective study on a sample of 82 individuals aged over 65 years, who presented for laboratory evaluations in an outpatient setting. They were recorded socio-demographic and clinical data; depression and anxiety were assessed using the Hospital Anxiety and Depression Scale. Blood samples were collected and analyzed according to the protocol of the study. Results Anxiety, identified in 57 persons, was not statistically significant correlated with the levels of inflammatory markers. For depressive disorder (37 subjects), both CRP and hs-CRP were significantly higher, with an almost medium effect size. Conclusions The high levels of CRP and hs-CRP are associated with the presence of depression in elderly patients, but not with the anxiety. Further and complex studies need to validate these findings on this group of age.

The low quality of life of patients with schizophrenia has been extensively discussed and investigated. Various aspects from gender, socio-demographic profile, and/or type of neuroleptic treatment have been taken into account in describing this condition. The purpose of this study is to assess the perceived quality of life of Romanian patients suffering from schizophrenia and to correlate it with gender differences, type of schizophrenia, family history of psychiatric illness, and type of antipsychotic treatment. 143 patients diagnosed with schizophrenia according to DSM IV-TR and ICD 10 were included in the study. Social demographic data were documented and further assessment was performed using the Subjective Well Being under Neuroleptic Treatment Scale –the short form (SWN-S) and the short version of the WHO- Questionnaire for The Quality of Life (WHO-QoL-BREF). The mental functioning dimension was higher in men than women; the social integration dimension was higher for the residual type of schizophrenia. Emotional regulation and the capacity of social integration did not show significant differences between patients who had a family history of mental illness and those who did not. Levels of self-control and physical functioning were better for patients treated with atypical antipsychotics and who did not report a family history of psychiatric illness. All five dimensions of the SWN-S were higher in patients treated with atypical antipsychotics, compared to those who were treated with typical antipsychotics. The study showed that for people with schizophrenia mental functioning was better preserved in men, in patients who did not have a family history of psychiatric illness, and in patients who were treated with atypical antipsychotics. The level of social integration was better in patients who were treated with atypical antipsychotics but this effect depended on the type of schizophrenia.

Context Atypical antipsychotics (AAs) are the first-line treatments for schizophrenia, schizoaffective disorder and bipolar disorder. However, they are now extensively utilized as off label in a myriad of diseases despite their frequently serious metabolic side-effects and hyperprolactinemia. Objective The purpose of our study was to observe long-term (one year) prolactin level change in first episode schizophrenia patients treated with one of the four AAs: olanzapine, quetiapine, amisulpride, ziprasidone. Design This study is an analysis of the prolactin level associated with the atypical antipsychotics used in European First Episode Schizophrenia Trial (EUFEST) study. Subjects and methods Seventy-three first episode schizophrenia patients from the 113 patients, randomized to one of the four AAs treatment arms. Prolactin level was obtained at baseline, 6 and 12 months for all the four AAs. Analyses have been done for each antipsychotic separately for each sex. Results For the male patients neither of the four antipsychotics have been associated with a statistically significant increase of prolactin level in the entire study (p>0.05). In case of the female patients, treatment with olanzapine (p=.021) and ziprasidone (p=.005) has been associated with a decrease of prolactin level in one year compared with baseline. Conclusions In both men and women, the administration of these four AAs is not associated with the increase of prolactin levels, moreover, in women's case, there is a reduction of prolactin values at administration of Olanzapine and Ziprasidone. These results are optimistic, suggesting that long term administration of these antipsychotics is safe regarding prolactin level.

Background: While the Coronavirus-19 pandemic is apparently receding, a second wave is still well possible Patients diagnosed with a severe mental illness (SMI) have an excess mortality and their lifespan is between 10 to 30 years shorter compared to general population [1] There are also discrepancies in healthcare access and its utilization in patients with SMI compared to general population [2] People with SMI are more vulnerable to infectious diseases What is more, Cov19 mortality seems to be double in males compared to females [3] Therefore, male SMI patients represent a particularly vulnerable group susceptible to both Cov-19 infection and a severe course of illness Aims: Our study aims to examine the level of information regarding the new Coronavirus-19 in SMI patients compared to general population Methods: We applied two questionnaires to male patients with severe mental illness One of the them was based on the five important affirmations from WHO [4] There were two possible answers for each question, true or false, with a maximum score of 5 points for each questionnaire The higher the score, the better the knowledge of preventive measures against infection with coronavirus Our sample consisted of 42 male inpatients from “Alexandru Obregia Psychiatric Hospital” admitted between March and June 2020 and 42 controls matched by gender, age and education Prior to filling the questionnaires, patients did not receive any formal information or education upon this topic, other than the instructions from the media Scores were compared using Mann Whitney test and results were considered statistically significant al alpha 0 05,2-tailed Results: Mean and median scores for the questions evaluating general information were: 6 95 (±1 75) and 7 (IQR 6-8 25) for SMI patients and 9 07 (±1 46) and 10 (IQR 8 75-10) for controls (U=315, Z=-5 21, p< 001) Mean and median scores for level of knowledge about WHO prevention measures were and 4 38 (±0 96) and 5 (IQR 4-5) for SMI patients and 4 76 (±0 62) and 5 (IQR 5-5) for controls (U=685 5, Z=2 25, p= 025) For fictitious information about COVID-19, SMI patients had a mean score of 2 52 (±1 63) and a median one of 3 (IQR 1-4) while controls had 4 33 (±1 16) and a median of 5 (IQR 4-5) (U=324, Z=-5 19, p< 001) Conclusion: To our best knowledge this is the first study evaluating Cov-10 information in SMI patients Patients with SMI had a lower knowledge of prevention methods against coronavirus There are multiple factors that can contribute to these results as the severity of the pathology, cognitive capacities, insight and it might be possible that some patients do not understand simple statements In addition, the SMI group was less likely to discern erroneous information from genuine advice For this matter, traditional ways of offering information to SMI patients may need altering and personalization since is of vital importance for infectious prevention and spreading of the virus No conflict of interest

One previous small single-center clinical trial showed that a single intravenous administration of sodium nitroprusside added-on to antipsychotics improved a wide spectrum of schizophrenia (SCZ) symptoms more than placebo, and the improvement persisted for 4 weeks after infusion even though no additional drug was given. Our study attempted to replicate these data in a 4-week, add-on, double-blind, randomized, placebo-controlled trial on 20 patients performed in a site in Romania and a site in Moldova. This study’s sample size and protocol were identical to the previous trial, including patients with a diagnosis of SCZ, within the first 5 years after diagnosis. Patients recruited needed to have a baseline total positive and negative syndrome scale (PANSS) score of 60 or above. Ten participants received a single dose of 0.5 µg/kg/min intravenous sodium nitroprusside over 4 hours, and 10 participants received matching placebo infusion, added-on to antipsychotics. The primary outcomes were the PANSS total score and the PANSS negative subscale. There were no significant between-group differences in PANSS total scores or negative subscale scores during the infusion on daily evaluations for the next 7 days nor on weekly evaluations at weeks 2, 3, and 4. No significant differences were found between the 2 study groups in adverse events. Meta-analyses including all 5 published randomized controlled trials on the topic, representing 155 subjects, do not show a statistically significant benefit of sodium nitroprusside. We conclude that the current evidence does not support the efficacy of sodium nitroprusside in the treatment of SCZ.

Context Schizophrenia is a chronic disease most frequently necessitating lifelong antipsychotic treatment. Selecting which antipsychotic is to be prescribed in an individual schizophrenia patient represents an important clinical decision that need to take into account efficacy and side effects. Objective Evaluating weight gain related with one year antipsychotic treatment in antipsychotic naive first-episode schizophrenia patients. Design This study is an analysis of weight gain associated with typical or atypical antipsychotics used in European First Episode Schizophrenia Trial (EUFEST) study. Subjects and methods 113 first episode naive antipsychotic schizophrenia patients included in EUFEST - Romanian cohort, who were randomized to one of the 5 treatment arms. Weight was obtained at baseline, 3, 6, 9 and 12 months for the 5 antipsychotics (typical-Haloperidol; atypical-Olanzapine, Amisulpride, Ziprasidone, Quetiapine). Results There are no statistically significant differences between groups treated with typical or atypical antipsychotics or between any individual antipsychotics concerning weight gain during the study. Weight gain was the highest in the first 3 months (57.49%) for all the studied neuroleptics. At the end of the study, the less increase was observed with ziprasidone (3.87 kg) and the highest with olanzapine (9.83 kg). Conclusion Increase in weight has taken place for each individual neuroleptic, but also as a group (all neuroleptics) in the first three months (57.49%). Therefore, we should address the issue of weight gain with great care, especially in first period of antipsychotic administration, in order to fast deploy intervention tailored to maintain pre-treatment weight.

Objectives Mood stabilizers administered for bipolar disorder during pregnancy, such as valproic acid, can increase the risk of congenital anomalies in offspring. Valnoctamide is a valproic acid derivative associated with a decreased risk for congenital abnormalities in animals. The present study evaluated the efficacy and safety of valnoctamide monotherapy, compared to placebo, in the treatment of patients in an acute manic episode. Methods A 3-week, double-blind, randomized, placebo- and risperidone-controlled, parallel group trial was conducted on 173 patients in an acute manic episode. Patients were randomized to receive valnoctamide 1500 mg/d (n=71), risperidone 6 mg/d (n=32), or matching placebo (n=70). The primary outcome measure was the change in Young Mania Rating Scale (YMRS) scores. Results Valnoctamide did not differ significantly from placebo on any of the study endpoints (YMRS, Positive and Negative Syndrome Scale, and the Clinical Global Impression Scale for Bipolar Disorder [CGI-BP] scales; all P>.60). Mixed models for repeated measures showed that risperidone produced significantly more improvement than placebo in the overall bipolar disorder CGI-BP severity scale (P=.036), and the CGI-BP severity scale for mania (P=.021). The Kaplan-Meier survival curve revealed higher all-cause discontinuation rates (mainly due to lack of efficacy) in the valnoctamide group compared to the other study groups (P=.026). Patients with higher valnoctamide plasma levels had a numerically higher YMRS response, but this was not statistically significant. Conclusions Valnoctamide was well tolerated at 1500 mg/d but lacked efficacy in the treatment of symptoms in patients with acute mania. Possible differences between the biological mechanisms of action of valproic acid and valnoctamide are discussed.

Several single-center studies have found raloxifene, an estrogen agonist, to be effective in ameliorating symptoms of schizophrenia in stable patients as augmentation of antipsychotics. This multicenter study assessed whether raloxifene plus antipsychotic treatment, in comparison to placebo plus antipsychotics, improves symptoms or cognition in severely ill decompensated schizophrenia patients.In this 16-week, double-blind, randomized, placebo-controlled study, 200 severely ill, decompensated postmenopausal women who met DSM-IV-TR criteria for schizophrenia or schizoaffective disorder were recruited from January 2011 to December 2012 and were randomized to receive either raloxifene 120 mg/d plus antipsychotics or placebo plus antipsychotics. The primary outcome measure was Positive and Negative Syndrome Scale (PANSS) total score at the end of the trial.The placebo plus antipsychotics group experienced statistically significant improvement in PANSS total score (P.001) compared to the raloxifene plus antipsychotics group, using mixed models for repeated measures, with results favoring placebo by 4.5 points (95% CI, 2.3-6.7). These results were clearly outside the 95% confidence interval. This negative effect was more pronounced in patients who had more frequent relapses and in those with baseline PANSS scores of 100 or higher. There were no differences between groups in Clinical Global Impression Scale-Severity scores or Composite Brief Assessment of Cognition in Schizophrenia scores at 16 weeks (P.3). Baseline follicle-stimulating hormone and estradiol levels did not alter the drug-placebo differences.Individuals in the active treatment arm showed worse outcome than those in the placebo arm, most likely as a result of chance variation, but the results unequivocally show no benefit of antipsychotics plus raloxifene versus antipsychotics plus placebo in this large randomized, double-blind, placebo-controlled trial in postmenopausal women. These data do not support the use of raloxifene in severely decompensated schizophrenia patients until reliable research identifies what subgroup of patients or domain of outcome is benefited.ClinicalTrials.gov identifier: NCT01280305.

Many patients do not respond to the first antipsychotic drug prescribed, but require multiple trials with different drugs before response is achieved. Current treatment guidelines vary substantially in their recommendations as to how long clinicians should wait before an antipsychotic treatment attempt should be considered as failed and the compound switched. It has, however, recently been shown that poor early response to an antipsychotic is associated with continuous poor later response in the course of the same treatment attempt. This finding suggests that patients who do experience poor early response might benefit from a switch in antipsychotic medication as early as 2 weeks after treatment initiation. In the SWITCH trial, 350 patients suffering from an acute episode of schizophrenia are randomly assigned to double-blind treatment with either olanzapine or amisulpride. The primary endpoint is symptomatic remission at week 8. Patients not experiencing at least minor response after 2 weeks are randomized again to either staying on the initially assigned drug or being switched to the alternative compound for another 6 weeks. In case early switching proves superior to maintaining treatment, time wasted for unsuccessful treatment attempts could be minimized, patients' outcomes improved, duration of hospital stays reduced, and thus overall treatment expenses saved. The current report will present the methods of the trial, focusing on various specific features which could be adopted by future studies.