Real-world effectiveness of long acting aripiprazole: Treatment persistence and its correlates in the Italian clinical practice.

OBJECTIVES: To identify the variables that are associated with persistence to Aripiprazole-Long Acting (A-LAI), in adult patients with schizophrenia. METHODS: Observational, retrospective, non-interventional study involving 261 patients with schizophrenia. RESULTS: Eighty-six percent of study subjects were persistent for at least 6 months. All subjects with baseline CGI-S of 1 or 2, 95% of subjects with CGI-S of 3, 86% with CGI-S of 4, 82% of subjects with CGI-S of 5, 73% of subjects with CGI of 6 and 90% of subjects with CGI of 7 were persistent. A-LAI treatment continuation rate was higher in patients with: 1) baseline CGI score ≤ 4; 2) schizophrenia dimension (LDPS) mania score ≤ 5; 3) psychotic spectrum schizoid score ≤ 11. CONCLUSIONS: A relatively high number of patients (n = 225, 86%) were persistent to A-LAI for at least 6 months. Not surprisingly, very severe patients were more unlikely to be persistent. However, it is noteworthy that a large number of subjects with high CGI score at the time when A-LAI was started (82% of subjects with CGI-S of 5, 73% of subjects with CGI of 6 and 90% of subjects with CGI of 7) were persistent. Larger, controlled, prospective and longer studies are warranted.

Depression severity and concentration difficulties are independently associated with HRQOL in patients with unipolar depressive disorders.

PURPOSE: Cognitive impairment is a core feature of major depressive disorder (MDD), and dysfunctions in this area strongly contribute to MDD-associated disability. Whether cognitive impairment has an independent clinical course and a unique impact on HRQOL is still debated. We sought to characterize the relationship between depression severity and HRQOL, evaluating the burden of concentration difficulties on HRQOL. METHODS: Six hundred ninety-two patients with unipolar depressive disorders recruited in 19 Italian centers answered a self-administered survey (SF-12 questionnaire, socio-demographic information). A psychiatrist completed a standardized data collection form encompassing a depression severity scale (MADRS) and clinical information. RESULTS: There was a strong graded association between the severity of depressive symptoms and both the physical (ω 2 = 0.13; p < 0.01) and mental (ω 2 = 0.34; p < 0.01) SF-12 domains. Additionally, we observed a strong association between concentration difficulties and all HRQOL outcomes independent of other symptoms of depression and robust to adjustment for possible confounders. CONCLUSIONS: Our data corroborate previous findings suggesting that cognitive impairment is a feature of unipolar depressive disorders partially independent of the severity of other symptoms, and may represent a specific target of therapy with a strong impact on patients' functioning and quality of life.

Estimating the Impact of Workplace Bullying: Humanistic and Economic Burden among Workers with Chronic Medical Conditions.

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.

Anti-anxiety efficacy of Sudarshan Kriya Yoga in general anxiety disorder: A multicomponent, yoga based, breath intervention program for patients suffering from generalized anxiety disorder with or without comorbidities.

BACKGROUND: Surdashan Kriya Yoga (SKY) is a procedure that in various studies, has shown evidences of efficacy in alleviating Depression and Anxiety disorders, but in Europe and USA it has not been studied yet on a Caucasian population as an adjunct therapy for psychiatric Disorders. METHODS: The study involved a sample of consenting women and men (n = 69) who received SKY therapy for a six-month time period. They were assessed at recruitment, after two weeks, after three months and after six months using Hamilton Rating Scale for Anxiety (HRSA), Hamilton Rating Scale for Depression (HRSD), Zung Self-Rating Anxiety Scale (ZSAS), Zung Self-Rating Depression Scale (ZSDS) and Symptom Checklist-90 (SCL-90). RESULTS: All the analyses have shown that SKY therapy significantly reduces the scores of Anxiety and Depression. This is plain, especially after the initial SKY treatment, which is followed by a long plateau phase that seems to verge on no Anxiety/Depression scores. It was found that SKY effects lead to a significant convergence between the self-assessment (Zung Self-Rating Scale) and hetero-assessment (Hamilton Rating Scale). LIMITATIONS: The study should be replicated on a larger clinical sample in a controlled trial to learn more about the effectiveness of SKY Protocol. CONCLUSIONS: Participation in SKY adjunct therapy ten days intense workshop and follow-ups, coupled with daily individual and independent practice of a simplified protocol of breathing techniques (30 min), can lead to significant reduction in levels of Anxiety and Depression.

Italian Study on Depressive Disorders (STudio Italiano MAlattia Depressiva, or STIMA-D): a nationwide snapshot of the status of treatment for major depression.

INTRODUCTION: Major depression is a worldwide problem and often remains undetected and untreated. Given the low rates of detection plus the need to intervene in a short time, it is important to identify factors which are likely to improve treatment outcomes. METHODS: STIMA-D was designed to provide the profile of patients with major depression in Italy (focusing on pathway to care, patient characteristics, drug therapy and treatment outcomes). The patients enrolled (M/F, aged between 18 and 65) experienced single/multiple episodes of major depression (DSM-IV-TR). Patients with lifetime or current bipolar syndrome or other mental disorders were excluded. RESULTS: 44 of the 50 invited centers sent data concerning 1 140 patients. The majority of patients were women. Among working individuals, 52.5% of them were absent from work due to depression in the previous 6 months. Recurrent episodes of major depression were very common and were associated with persistence of residual post-episodic symptoms, a family history of mood disorders and presence of anxiety. 59.6% of the patients were treated with monotherapy (SSRI or SNRI), while 19.2% of them were treated with SSRI plus SNRI. Only the 25.5% on monotherapy had a complete response compared to 12.4% of patients on dual therapy. DISCUSSION: Poor outcomes in major depression have profound implications on patients' quality of life and cost burden. New pharmacological approaches with novel modes of action are therefore urgently needed.

Efficacy and tolerability of switching to ziprasidone in italian patients with acute exacerbation of schizophrenia: an open-label trial.

The long-term maintenance of a stable condition is an important aim of schizophrenia therapy, which frequently requires the switch between 2 antipsychotic agents. This 8-week multicenter study, conducted in Italy, evaluates the switch from a previous antipsychotic to ziprasidone.Adult acute schizophrenic patients requiring a change in antipsychotic for lack of efficacy or tolerability issues took ziprasidone 20 - 80 mg/bid. Dosages could be adjusted during the study. The primary efficacy outcomes were the differences in positive and negative syndrome scale (PANSS) and clinical global impression severity (CGI-S) scores from baseline to study end. Other efficacy variables were clinical global impression improvement, global assessment of functioning, patient preference scale and drug attitude inventory.189 patients were evaluated; the mean (±SD) ziprasidone dose was 95.9±34.5 mg/day. PANSS and CGI-S scores significantly decreased throughout the study. All secondary outcomes significantly improved at the end of the study vs. baseline values. Ziprasidone was well tolerated; 13 patients reported a QTc prolongation (mild in 12 patients).Notwithstanding the limitations of any non-comparative study, these results suggest that ziprasidone may be an effective and well-tolerated option in acute schizophrenia patients who discontinued a previous antipsychotic agent.

Clinical outcome and tolerability of duloxetine in the treatment of major depressive disorder: a 12-week study with plasma levels.

Duloxetine (DLX) is a dual serotonin and norepinephrine reuptake inhibitor that has been recently approved for the treatment of major depressive disorder (MDD). However, little is known about the relationship between DLX plasma levels and clinical response. The aims of this open-label study were 1) to assess clinical outcome and tolerability of DLX by means of clinician and patient assessments and 2) to evaluate the value of plasma DLX levels as predictors of clinical response and tolerability. This was a naturalistic, open-label study of 45 outpatients affected with MDD (16 men and 29 women), who received DLX at doses of 30-120 mg/day and were evaluated at baseline (T0) and after 2, 4 and 12 weeks (T1-3). The assessments included the Hamilton Rating Scales for Depression (HRSD) and Anxiety (HRSA), Clinical Global Impression-Severity (CGI-S), Beck's Depression Inventory (BDI) and a mood visual analogue scale (VAS). Compared with T0, there were significant improvements in HRSD at T1, T2 and T3 (P < 0.001), in HRSA, CGI-S and the self-administered BDI at T2 and T3 (P < 0.001), and in the VAS scores shown at T3 (P = 0.01). DLX treatment was safe and well tolerated. Plasma DLX levels at T2 ranged from 5 to 135 ng/mL (mean +/- SD = 53.56 +/- 39.45) and correlated almost significantly with the DLX dose (r = 0.35; P = 0.069). There was a significant curvilinear quadratic relationship between the improvement of HRSA scores and plasma DLX levels (R(2) = 0.27; P = 0.02). The incidence of anxiety or irritability was associated with the highest plasma levels. Our findings suggest that monitoring plasma DLX levels may be helpful in predicting better treatment responses and tolerability. The present data seem to suggest an optimal anxiolytic efficacy of DLX at intermediate plasma levels.

The long-term efficacy and tolerability of carbolithium once a day: an interim analysis at 6 months.

Evidence supporting the use of lithium in the long-term care of bipolar disorder patients is unequaled; fluctuations of lithium (Li) plasma concentration, however, are associated with side effects at peak, and symptomatic states at trough, Li plasma levels. Slow release preparations represent a means of maintaining stable Li plasma levels and thereby: [1] reducing side effects, [2] requiring fewer daily administrations, [3] possibly providing more stable therapeutic response and [4] improving patient compliance. The aim of the present study is to investigate the long-term efficacy and tolerability of a new prolonged release formulation of Li, called Carbolithium Once A Day (OAD), in patient with bipolar disorder previously treated with standard Li. Upon completion, the study will last for 2 years; this paper, however, is an interim analysis of tolerability and clinical outcome of 4-month (N = 27) and 6-month (N = 15) completers. Li plasma levels and doses remained relatively stable throughout the periods of observation (days 30, 60, 120, and 180). Doses of OAD did not differ significantly from doses on prior standard Li in subjects at 4 months (681 +/- 160 and 665 +/- 154 mg/d, respectively) or 6 months (647 +/- 161 and 710 +/- 192 mg/d, respectively). Correspondingly, Li plasma levels on previous traditional Li and on OAD were not significantly different at 4-months (0.47 vs 0.46 mEq/l respectively. Wilcoxon z = 0.456, p = 0.648) or 6-months (0.47 and 0.51 mEq/l respectively, Wilcoxon z = 0.220, p = 0.826). Among 4-month completers, improvement in mania scores was significant (Wilcoxon z = 2.366, p = 0.018), but was not at 6-months. Significant reduction of scores on the Melancholia Scale was observed among both the 4 and 6-month completers (Wilcoxon z = 3.516, p < 0.001 and z = 2.521, p = 0.012, respectively). The occurrence of side effects was significantly reduced among patients switched from traditional Li. All patients declared their preference for OAD over traditional Li for its better tolerability and case of use at day 30.