The European Journal of Psychiatry

Major depression: does gender influence the risk of recurrence? A systematic review

Background and Objectives: A woman's lifetime risk of major depression is almost twice as high as that of a man. Major depression is associated with a high risk of recurrence, but the question of a differential risk of recurrence between genders is unclear. Based on a systematic review of the literature, this paper attempts to answer the following question: "Following a major depressive episode, do women and men have the same risk of recurrence?". Methods: We prospectively collected all studies from the period 2005-2014 where the variable gender was considered a potential predictor of recurrence. The database has also been expanded with articles cited in the bibliography of the prospectively collected articles and with a PubMed Database search covering the period January 2005-August 2014. Results: Of the prospective studies (n = 98), most found no influence of gender on recurrence risk, but a minority, mostly large sample studies, found that female gender is a statistically significant risk factor for recurrence. Results suggest a probable female-to-male relative risk of recurrence between 1.0 and 1.2. Given the heterogeneity of the studies (length of follow-up, populations, nature of the studies, choice of dependant variables, statistical methods, and available data) no meta-analyses were performed. There are many interfering variables (age of onset, subchronic evolution, treatments, etc.) that can influence the results of prospective studies. Conclusions: Women probably have a slightly higher risk of recurrence after a major depressive episode than men. This increased risk is much smaller than women's much higher lifetime risk of depression.

Clinical trial designs of new medicinal products for treating schizophrenia: discussion of EMA's Guideline and a Better Long Term Trial Design

Background and Objectives: Schizophrenia is a severe chronic disease. Endpoint variables lack objectivity and the diagnostic criteria have evolved with time. In order to guide the development of new drugs, European Medicines Agency (EMA) issued a guideline on the clinical investigation of medicinal products for the treatment of schizophrenia. Methods: Authors reviewed and discussed the efficacy trial part of the Guideline. Results: The Guideline divides clinical efficacy trials into short-term trials and long-term trials. The short-term three-arm trial is recommended to replace the short-term two-arm active-controlled non-inferiority trial because the latter has sensitivity issues. The Guideline ultimately makes that three-arm trial a superiority trial. The Guideline discusses four types of long-term trial designs. The randomized withdrawal trial design has some disadvantages. Long-term two-arm active-controlled non-inferiority trial is not recommended due to the sensitivity issue. Extension of the short-term trial is only suitable for extension of the short-term two-arm active-controlled superiority trial. The Guideline suggests that a hybrid design of a randomized withdrawal trial incorporated into a long-term parallel trial might be optimal. However, such a design has some disadvantages and might be too complex to be carried out. Authors suggest instead a three-group long-term trial design, which could provide comparison between test drug and active comparator along with comparison between the test drug and placebo. This alternative could arguably be much easier to carry out compared with the hybrid design. Conclusions: The three-group long-term design merits further discussion and evaluation.

Levels of salivary immunoglobulin A under psychological stress and its relationship with rumination and five personality traits in medical students

Background and Objectives: The measurement of salivary immunoglobulin A is a useful and non-invasive method for measuring stress. Personality traits and rumination act as possible mediators in the relationship between psychological stressors and the immune system. This study was aimed to evaluate the levels of salivary IgA under psychological stress and its relationship with rumination and five personality traits in medical students. Methods: In this cross- sectional study, 45 medical students who intended to participate in the final exam were selected by simple random sampling. Two months before the exam, in the basal conditions, the NEO Personality Inventory-Short Form and Emotional Control Questionnaire (ECQ) were completed. Saliva samples were taken from students in both the basal conditions and exam stress conditions. Salivary IgA was measured by an ELISA test. Data was analyzed using paired samples T-test, Pearson correlation analysis, and stepwise regression. Results: A significant reduction of salivary IgA levels was found in exam stress conditions. Also, a significant negative correlation was found between traits of neuroticism and rumination with salivary IgA, as well as a significant positive correlation between of openness to experience and emotional inhibition with salivary IgA. Openness to experience and emotional inhibition may predict a substantial variance (34%) of salivary IgA under exam stress. Conclusions: Salivary IgA is reduced in response to exam stress. In addition, the rumination and personality traits may reduce or increase stress effects on the immune system, particularly the salivary IgA.

Insight assessment in psychosis and psychopathological correlates: validation of the Spanish version of the Schedule for Assessment of Insight - Expanded Version

Background and Objectives: Lack of insight is a cardinal feature of psychosis. Insight has been found to be a multidimensional concept, including awareness of having a mental illness, ability to relabel psychotic phenomena as abnormal and compliance with treatment., which can be measured with the Schedule for Assessment of Insight (SAI-E). The aim of this study was to validate the Spanish version of SAI-E. Methods: The SAI-E was translated into Spanish and back-translated into English, which was deemed appropriate by the original scale author. Next, the Spanish version of the SAI-E was administered to 39 patients with schizophrenia or schizoaffective disorder (DSM-IV criteria) from a North Peruvian psychiatric hospital. The Positive and Negative Syndrome Scale for Schizophrenia (PANSS) and the Scale of Unawareness of Mental Disorder (SUMD) were also administered. Specifically, internal consistency and convergent validity were assessed. Results: Internal consistency between the 11 items of the SAI-E was found to be good to excellent (α = 0.942). Compliance items did not contribute to internal consistency (A = 0.417, B = 572). Inter-rater reliability was excellent (ICC = 0.99). Regarding concurrent validity, the SAI-E total score correlated negatively with the lack of insight and judgement item of the PANNS (r = -0.91, p <0.01) and positively with the SUMD total score (r = 0.92, p <0.001). Conclusions: The Spanish version of the SAI-E scale was demonstrated to have both excellent reliability and external validity in our sample of South American Spanish-speaking patients with schizophrenia spectrum disorders.

Incidence of violent behavior among patients in Psychiatric Intensive Care Units

Background and Objectives: Both psychiatric acute units and psychiatric intensive care units (PICUs) focus on acute treatment of behavioral disturbances such as violence and aggressive threats and acts. The aim of the present study is to describe the frequency of violent behavior; such as verbal or physical threats and physical attacks, among patients admitted to psychiatric intensive care unit (PICU). In addition the relationship between the episodes of threats and/or attacks in relation to time of the day, days of the week, and their seasonal variations was explored. Methods: All violent behavior was continuously assessed at the psychiatric emergency department. Data were collected during the period from May 2010 to May 2012. Results: Patients with only one hospitalization were less violent than those who have had two hospitalizations. There was a statistically significant difference in violence among patients without formal secondary education and those who have not formal education. Violent behavior showed two peaks during the day; the first occurring at 1 pm and the second at 8 pm. In regard to seasonality, summer had a higher incidence of violence. The most peaceful seasons of the year were spring and autumn. Conclusions: Violent behavior shows variation in daytime, days of the week and season in acute psychiatric intensive care. Daytime variation shows two peaks of violence at 1 pm and 8 pm, Sundays and Wednesdays being the quietest days regarding violence both in winter and summer. Patient's level of education and hospitalization status partially explain the variation.

Cerebrotendinous xanthomatosis with bradyphrenia and psychiatric disorders: a case with ¹⁸F-FDG PET imaging and a literature review

Background and Objectives: Cerebrotendinous xanthomatosis (CTX) is a rare autosomal recessive lipid-storage disease caused by mutations in the CYP27A1. The purpose of this study is to determine the clinical characteristics, neuroimaging and mutation detect in a family with CTX systematically. Methods: Collecting history materials and detecting the routine clinical biochemical tests and imaging examination, and for the first time taking the whole body positron emission tomography (PET)-CT examination for probed in the world to research abnormal metabolism activities in CTX. To observe the effect of treatment with chenodeoxycholic acid (CDCA) and stains before and after the intervention, using serum lipid level detection and neuropsychological evaluation. Genetic testing was carried out to screen the nine exons and exon-intron boundaries about 200-300bq of CYP27A1. Results: A 37-year-old woman with typical clinical characteristics of CTX. Magnetic resonance imaging (MRI) of brain showed bilateral lesions in the dentate nucleus of the cerebellum, then, PET images revealed multiple abnormal hypermetabolism areas at distal tendon, and multifocal areas of hypometabolism in bilateral sides of cerebellar hemispheres, the frontal lobe and temporal lobe. Histopathology reveals accumulation of xanthoma cells and dispersed lipid crystal clefts in xanthomas. In genetic analysis, it shown an insertion of cytosine (77-78insC) located in the first exon of CYP27A1 in the proband. Conclusions: We found that a Chinese patient presented a typical clinical feature of CTX along with clear correlation on both structural and functional imaging had a novel mutation in the CYP27A1 gene.