The study gathered information in order to draw useful conclusions to describe bipolar patients and their clinical management. The data collection was conducted as part of RENDiBi epidemiological study. The statistical analysis of the collected data will be essential to understand the possible changes in drug treatment, through the help offered by a parameter, Polarity Index (PI), the numerical expression of the efficacy profile of a drug, very useful especially in the long-term management. Administration of a first detection card (demographic data, medical history) and five scales (CGI-BP, Mood Insight Scale, YMRS, HDRS) and a structured interview (MINI). The parameters analyzed were: polarity prevalence, ratios efficiency (IE) (values indicating the effectiveness of treatment compared to manic components and/or depressive), treatment and PI. The degree of correlation between PI and IETot is positive and statistically significant. The correlation between PI and IEm is statistically significant; the correlation is however not significant between PI and IEd; treatment with antipsychotics alone has increased PI, while the one with mood stabilizers has lesser; treatment with antipsychotics has increased PI in patients with predominantly polarity than those with manic depressive prevailing polarity. There is a correlation between PI and effectiveness on manic symptoms and it is statistically significant (as already evident in the literature). The PI is numerically higher in the treatment of the subject with manic polarity, in agreement with previous studies that associate to the more effective drugs used for the management of manic recurrences a higher PI.

Recent evidence, such as that from the STAR-D study, have demonstrated that several unmet needs are still present in the treatment of major depression. The "classical" approach adopted to develop new antidepressants drugs, based on selectivity, did not result in increased remission rates in clinical practice, whereas multi-modality represents a new approach to develop novel antidepressants endowed with multiple actions that affect several pharmacological targets. Multimodal antidepressants, developed in the last three years, act through at least two pharmacological modes of action (serotonin reuptake inhibition, agonist/antagonists on neurotransmitter receptors) on at least two or more pharmacologic targets. Vortioxetine is a novel multimodal antidepressant that exerts its antidepressant efficacy in animal models of depression through a combination of two pharmacological modes of action: reuptake inhibition and receptor activity. In vitro studies indicate that vortioxetine is antagonist of 5-HT 3, 5-HT 7 and 5-HT 1D receptors, a partial ago-nist of 5-HT 1B receptors, an agonist of 5-HT 1A receptors, and inhibitor of the serotonin transporter. The combination of 5-HT 1A agonism with 5-HT 3 antagonism can explain the rapid 5-HT cell firing induced by vortioxetine compared to SSRIs such as fluoxetine. Vortioxetine is also able to activate the glutamatergic system in the rat frontal cortex through antagonism at 5-HT 3, 5-HT 7 receptors. All these pharmacological modes of action can contribute to explain the increased clinical efficacy of vortioxetine in the treatment of cognitive symptoms of depression. Cognitive deficits in depression are often associated with both a suboptimal response to antidepressants and reduced remission rates. Vortioxetine is the first multimodal antidepressant available for the treatment of depression with a specific, positive impact on cognitive symptoms.

Background . Although the prevalence of work-limiting diseases is increasing, the interplay between occupational exposures and chronic medical conditions remains largely uncharacterized. Research has shown the detrimental effects of workplace bullying but very little is known about the humanistic and productivity cost in victims with chronic illnesses. We sought to assess work productivity losses and health disutility associated with bullying among subjects with chronic medical conditions. Methods . Participants (N=1717) with chronic diseases answered a self-administered survey including sociodemographic and clinical data, workplace bullying experience, the SF-12 questionnaire, and the Work Productivity Activity Impairment questionnaire. Results . The prevalence of significant impairment was higher among victims of workplace bullying as compared to nonvictims (SF-12 PCS: 55.5% versus 67.9%,p<0.01; SF-12 MCS: 59.4% versus 74.3%,p<0.01). The adjusted marginal overall productivity cost of workplace bullying ranged from 13.9% to 17.4%, corresponding to Italian Purchase Power Parity (PPP) 2010 US$ 4182–5236 yearly. Association estimates were independent and not moderated by concurrent medical conditions. Conclusions . Our findings demonstrate that the burden on workers’ quality of life and productivity associated with workplace bullying is substantial. This study provides key data to inform policy-making and prioritize occupational health interventions.

IntroductionThe scales for the assessment of depressive symptoms, translated and validated in Italian, lacks in the recognition of the psychopathological nuances of the disorder. The Bipolar Depression Rating Scale (BDRS) is a tool specifically built to reflect the characteristics of bipolar depression.MethodsScreening criteria:-aged 18–65 years-diagnosis of BD (DSM-IV-TR) (125 patients) or-diagnosis of MDD (DSM-IV-TR) (30 patients)-manifestation of depressive symptoms-no further psychiatric comorbidity on axis I and axis II (including abuse/addiction)-no serious cognitive deficitsPsychometric battery:Bipolar Depression Rating Scale (BDRS),Hamilton Depression Rating Scale (HAM-D),Montgomery-Asberg Depression Rating Scale (MADRS),Young Mania Rating Scale (YMRS).ResultsThe analysis of the BDRS scores, according to the Kolmogorov-Smimov method shows a normal distribution; the α Cronbach's coefficient shows that the the scale, in its Italian version, has considerable validity and reliability (r = 0.82). The factor analysis was verified using the Varimax rotational method: after several tests, we found 2 subscales, one linked to mixed/depressive symptoms and a second related to (hypo)manic symptoms.ConclusionsThe BDRS is a valid scale for the measurement of depression in patients with Bipolar Disorder, with a notable internal consistency (Cronbach α 0.82), a significant consistency between items/total (Cronbach α from 0.80 to 0.82) and positive correlation with other scales (MADRS r 0.67, p < 0.001; HAM-D r 0.81, p < 0.001; YMRS r 0.46 p < 0.0001), including the Young Mania Rating Scale (better than the original validation sample Berk et al., 2007).

Asenapine is a second-generation antipsychotic that is administered sublingually; the compound received regulatory approval two years ago by FDA for the acute treatment of schizophrenia in adults, and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. In the EMA, at the present, asenapine is approved only for the acute treatment of manic episodes associated with bipolar I disorder in adults.The aim of this review is to summarize published data in both the literature and regulatory documents on efficacy and safety of asenapine for the treatment of bipolar disorder.

Depression has a lifetime prevalence of 10–25% among women and 5–12% among men. Selective serotonin reuptake inhibitors (SSRIs) are the most used and the most cost effective treatment in long-term MDD. Since the introduction of generic SSRIs the costs of the branded drug have been questioned. The objective of this study is to analyze the Cost-effectiveness of the most prescribed SSRIs: sertraline, paroxetine, citalopram, that lost their patent, and escitalopram that is still covered by a patent. A decision analytic model was adapted from TLV (Dental and Pharmaceutical Benefits Board, Sweden) in order to reflect the current clinical practice in depression helped by a panel of Psychiatrists and Health economists. Perspective used was the Lombardy Region Health Service and the Time horizon was 12 months. Several scenario simulations, one way Sensitivity analyses and Monte Carlo simulations have been performed in order to test the robustness of the model. Base case scenario showed an ICER of escitalopram vs. sertraline of € 4.395. All the tests showed that citalopram and paroxetine are dominated. One way Sensitivity analyses and tests were performed resulting in ICER variation from € 135 to € 18.000, nevertheless Monte Carlo simulations have shown an ICER stabilized at the mean value of around 4.000 euro confirming the base case scenario. ICER represents the additional cost due to a new technology related to its additional benefits. ICER has to be compared with a meaningful threshold value under which a technology may be considered cost-effective. Many agencies have studied this threshold. PBAC (Australia) propose € 25K, NICE (UK) propose € 35K. Comparing our base case scenario and also the ICER ranges that came from the Sensitivity analyses (One way and multivariate) with these thresholds escitalopram should be accepted as a cost-effective treatment for MDD.

Some psychotropic drugs are connected with prolongation of the QT interval, torsade de pointes and sudden death. Recent data suggest that with regard to this adverse effect, the atypical antipsychotic drugs are no safer than the older drugs. The purpose of this study is to evaluate the different use of first generation versus second generation antipsychotics as add-on (Group I) or switch treatment (Group II) and its effect on QTc interval in a sample of schizophrenic and bipolar inpatients without medical illness. All patients had been evaluated twice by using ECG: on admission and after two weeks of hospitalization. Exclusions criteria were: abnormalities in levels of potassium, magnesium and calcium, cardiovascular and metabolic diseases, alcohol or drug abuse. We found a significant (p < 0.01) greater use of first generation antipsychotic in Group I (73.80%) than in the Group II (33.33%). Also Group I showed a significant increase (p < 0.0001) in total chlorpromazine equivalent (476. 78 ± 448.80 mg/day vs 845.48 ± 491.64 mg/day) and in QTc interval (369.14 ± 33.75 ms vs 387.09 ± 31.97 ms), while we did not find any statistical difference in Group II during hospitalization. Our results, in spite of the small sample size, indicate that antipsychotic add-on can increase QTc interval more than switching to other antipsychotic in psychiatric patients without other risk factors.

Background: The prevalence of bipolar spectrum disorders in the community is under debate and the prescription of antidepressant drugs (ADs) in bipolar depression appears to be an underestimated problem.Objectives: To evaluate the prevalence of bipolar disorders by means of a screening instrument in seven communities within six regions of Italy and evaluate the appropriateness and number of prescriptions for ADs in bipolar depression.Methods: Study design: community survey. Study population: samples randomly drawn, after stratification from the adult population of municipal records. Sample size: 4999 people from seven communities within six regions of Italy. Tools: questionnaire on psychotropic drug consumption, prescription, health services utilization; Structured Clinical Interview NP for DSM-IV modified (ANTAS); Mood Disorder Questionnaire (MDQ). Training: interviewers were trained psychologists or medical doctors. Study limitations: the population studied did not represent a nationally representative multistage clustered area probability sample of households.Results: 3398 subjects were interviewed (68% of recruited sample). Positivity at MDQ (MDQ+) was higher in males (3.4% vs. 2.8%) but the difference was not significant (OR = 1.2, P = 0.37). The association between MDQ+ and Major Depressive Disorder (MDD) was statistically significant for both males (OR = 14.9, P<0.0001) and females (OR = 8.3, P<0.001); 30% of subjects with MDQ+ and MDD lifetime diagnosis were taking ADs.Conclusions: These overall rates of being MDQ+ are similar to community surveys conducted within USA and the use of ADs in people with MDQ+ and MDD diagnoses are. (C) 2011 Elsevier B.V. All rights reserved.

IntroductionPatients with chronic hepatitis C, during antiviral treatment, develop haematological and psychiatric side effects which negatively affect the health-related quality of life and compliance. The aims of this study were to investigate the correlation between haematological abnormalities, quality of life and antiviral treatment-induced depression.MethodsWe enrolled thirty-two patients with chronic hepatitis C who, before starting the antiviral treatment, were without any psychiatric disorder according to DSM-IV criteria. Data on health-related quality of life, depressive symptoms, laboratory values and socio-demographic characteristics were collected. Seven patients developed a Major Depressive Disorder after four weeks of antiviral therapy and started an antidepressant.ResultsAll patients showed a significant impairment in health-related quality of life after four weeks of antiviral treatment (Table I). Patients who developed Major Depressive Disorder (G1 group) had more severe depressive symptoms, greater impairment on healthrelated quality of life, and higher haemoglobin levels than non-depressive patients (G2 group) (Table II). After eight weeks of antidepressant treatment, the G1 group showed significant reduction in depressive symptoms and significant improvement in physical functioning (Table V).ConclusionsAnti-viral therapy is associated with haematological and psychiatric side effects along with diminished quality of life. Antidepressant treatment can reduce depressive and physical symptoms with an improvement in health-related quality of life.

Background: Over the past decade, use of the atypical antipsychotic drugs clozapine, risperidone, olanzapine, and quetiapine has significantly changed the treatment of schizophrenia in the United States. The ability to make optimal drug choices will depend on determining whether there are clinically important differences between these drugs.Objective: This review describes ziprasidone, the most recently introduced antipsychotic drug. Its mechanism of action, pharmacokinetics, and adverse-effect profile are discussed, and the results of clinical efficacy trials are summarized.Methods: This review of ziprasidone is based on data from premarketing clinical efficacy and safety trials, a briefing document from the US Food and Drug Administration Psychopharmacological Drugs Advisory Committee, published studies, and abstracts presented at national and international meetings. International Pharmaceutical Abstracts and MEDLINE were searched for relevant citations, with no limitation on year.Results: Ziprasidone has been reported to be an effective antipsychotic drug for both positive and negative symptoms of schizophrenia, and long-term use has been effective in preventing relapse. Its 5-hydroxytryptamine (HT)1D—antagonist and 5-HT1A—agonist activity are consistent with a potential for antidepressant and anxiolytic activity beyond its antipsychotic effects. Ziprasidone has been associated with a low incidence of sedative effects, a low likelihood of extrapyramidal symptoms and postural hypotension, and no anticholinergic effect, although it may cause transient hyperprolactinemia. Unlike most atypical antipsychotic drugs, ziprasidone is not associated with weight gain, hyperlipidemia, or elevated plasma glucose levels. It is, however, more likely than other atypical antipsychotic drugs to increase the QTc interval (QT interval corrected for heart rate). For acute psychotic symptoms in patients with schizophrenia, schizoaffective disorder, or acute mania, ziprasidone is administered twice daily at a usual daily dose of 80 to 160 mg, whereas 40 mg/d may be an effective maintenance dose.Conclusions: Differences in efficacy and tolerability between existing atypical antipsychotic drugs allow individualization of drug therapy for patients with schizophrenia or schizoaffective disorder. Ziprasidone differs from other atypical antipsychotic drugs in several clinically important ways, although further experience is necessary to clarify the significance of these differences.