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Treatment-resistant Depression (TRD) represents a widespread disorder with significant direct and indirect healthcare costs. esketamine, the S-enantiomer of ketamine, has been recently approved for TRD, but real-world studies are needed to prove its efficacy in naturalistic settings.Evaluate the effectiveness and safety of esketamine nasal spray in a clinical sample of patients with TRD from several Italian mental health services.REAL-ESK study is an observational, retrospective and multicentric study comprising a total of 116 TRD patients treated with esketamine nasal spray. Anamnestic data and psychometric assessment (MADRS, HAMD-21, HAM-A) were collected from medical records at baseline (T0), one month (T1) and three month (T2) follow-ups.A significant reduction of depressive symptoms was found at T1 and T2 compared to T0. A dramatic increase in clinical response (64.2 %) and remission rates (40.6 %) was detected at T2 compared to T1. No unexpected safety concerns were observed, side effects rates were comparable to those reported in RCTs. No differences in efficacy have been found among patients with and without psychiatric comorbidities.The open design of the study and the absence of a placebo or active comparator group are limitations. The study lacks an inter-rater reliability evaluation of the assessments among the different centres. Side effects evaluation did not involve any specific scale.Our findings support the safety and tolerability of esketamine in a real-world TRD sample. The later response and the non-inferiority in effectiveness in patients with comorbidities represent novel and interesting findings.

Background Lithium is recommended as a first-line treatment for Bipolar Disorder (BD). Thyroid and renal alterations are well known lithium side-effects, while effects on parathyroids are less studied. The aim of this case-control cross-sectional study is to compare parathyroid hormone (PTH) and calcium levels in lithium-exposed bipolar patients and in subjects who had never been exposed to lithium. Methods 112 BD patients were enrolled, 58 on lithium since at least 1 month (mean exposure 60.8±74.8 months) and 54 in the control group. Blood exams included complete blood count, PTH, total and ionized calcium, TSH, T3 and T4, creatinine, urea, sodium and potassium, and lithium serum levels. The Student's t-test and the Pearson's Chi-square test were used for bivariate analyses. A linear regression model was used to analyze the relationship between the duration of exposure to lithium and PTH and calcium levels. Results PTH and ionized calcium levels were significantly higher in lithium-exposed patients; the proportions of subjects with hyperparathyroidism (8.6%) and hypercalcaemia (24.1%) were significantly greater in lithium-exposed patients. The linear regression analyses showed a significant effect of exposure to lithium in months on ionized calcium levels but not on PTH levels. Limitations Given the cross-sectional design of the study we could not identify the exact time of occurrence of hyperparathyroidism. Conclusions Our results indicate that lithium-associated stimulation of parathyroid function is more common than assumed to date. Among parameters to be evaluated prior to lithium implementation and during long-term lithium maintenance, calcium (and eventually PTH) should be added.

BACKGROUND: Few studies investigated the impact of anxiety disorder comorbidity on health-related quality of life (HRQoL) of bipolar patients and none examined bipolar subtypes differences. The aim of the study was 1) to determine comorbidity rates for anxiety disorders in euthymic bipolar subjects, comparing bipolar type I and II disorders (BDI and BDII), and 2) to compare within each group HRQoL measures in subjects with and without anxiety comorbidity. METHODS: Comorbidity was evaluated through the SCID-I; HRQoL was assessed using the 36-Item Short-Form Health Survey (SF-36). All subjects were euthymic since at least 2 months, as confirmed by a HAM-D

Background There is lack of data regarding BDNF serum levels in patients with obsessive–compulsive disorder (OCD). The aims of the present study were: 1) to assess the serum BDNF content in a sample of drug-naive patients with OCD and 2) to assess whether putative alterations in peripheral BDNF may be associated to OCD severity and clinical characteristics. Methods Twenty-four drug-naive patients with a principal diagnosis of OCD were recruited. In parallel, a control group of 24 unrelated volunteers matched for gender and age was enrolled. Serum BDNF levels were measured by ELISA method. Results The results showed that BDNF levels were decreased in OCD patients when compared to controls (36.90 ± 6.42 ng/ml versus 41.59 ± 7.82 ng/ml; p = 0.043). No correlations were evidenced between serum BDNF content and the severity of OCD symptoms measured as Y-BOCS scores or other clinical variables. Limitations The choice of drug-naive patients with obsessive–compulsive disorder had limited the size of the sample and excluded the recruitment of patients with a severe symptomatology. Conclusions Our findings reveal for the first time in OCD patients a decrease in serum BDNF levels. These data corroborate the hypothesis of a dysfunction in the neurotrophin expression in the OCD pathogenetic mechanism and provide the rationale for further investigations directed to the identification of novel biomarkers and new therapeutic strategies for antiobsessional treatments.

Background Brief dynamic therapy (BDT) has been shown to be effective in treating depressive disorders. Nevertheless, whether its effect is related to the severity of depression is still unknown. The aim of this study was to analyze whether the efficacy of BDT is related to severity of depressive symptoms in patients with mild to moderate unipolar depressive disorders. Methods A randomized clinical trial compared BDT with brief supportive psychotherapy (BSP) in 88 outpatients with depressive disorders. Two subgroups of patients were considered for statistical analysis: with mild depressive disorders (HAM-D 17 baseline score: 8–13) and with moderate depressive disorders (HAM-D 17 baseline score: 14–18). Patients were assessed at start of treatment (baseline-T0), at the end of treatment (T1) and at 6-month follow-up (T2). Results In the subgroup of patients with mild depressive disorders, no statistically significant differences emerged between the two treatments on all efficacy measures. In the subgroup of patients with moderate depressive disorders, the remission rates of patients treated with BDT were higher than those of patients treated with BSP at 6 month of follow-up (90.5% vs. 34.8%: p Limitations The sample size was relatively small; a longer follow-up period should be considered to assess the efficacy of BDT in terms of prevention of recurrences. Conclusions The efficacy of BDT in treating depressive disorders is higher in moderate than in mild depression.

Introduction For patients who continue to experience depressive symptoms despite an adequate antidepressant SSRI trial, across-class switch is considered one of the best treatment options. The goal of the present work was to compare in terms of efficacy two different dual-action compounds, duloxetine and bupropion, in patients who failed to respond in two consecutive antidepressant trials with SSRIs. Methods The patients were allocated randomly to duloxetine (120 mg daily) or bupropion extended release (300 mg daily). The intended medication period was 6 weeks. The primary measure of efficacy was depressive symptoms severity. Results A total of 49 participants were randomly assigned to duloxetine 120 mg (n = 27) or bupropion 300 mg (n = 22). The ITT efficacy patient sample consisted of 46 patients. Relatively high response and remission rates in treatment groups were found: from 60 to 70% of patients responded to treatment, and approximately 30 to 40% were in remission by the endpoint (week 6). No statistically significant difference emerged between the two groups at any post-baseline assessment, neither on mean scores of rating scales nor on qualitative efficacy measures. Limits Limitations of the study are the lack of a placebo arm, difficult to include owing to ethical reasons, and the relatively small size of the sample. Conclusions These preliminary results seem to support the hypothesis that in patients unresponsive to SSRIs the administration of antidepressants with different mechanisms of action is an effective switching strategy. Further studies are needed in light of the challenge posed by resistant depression.

Background There are conflicting results regarding the association of maternal antenatal distress with preterm birth and low birth weight. This study investigated the association between maternal distress and intrauterine growth abnormality, low birth weight and preterm birth. Methods Three mutually exclusive and homogeneous groups of pregnant women (with actual psychiatric disorder, with maternal psychological distress, and healthy comparisons) underwent fetal ultrasound examinations, uterine and umbilical artery Doppler velocimetry. Infant weight was measured and information collected on obstetrical features and sociodemographic factors. Results No differences emerged among the three groups of pregnant women in any ultrasound variables. Antenatal maternal psychiatric disorders and antenatal distress were not associated with an increased risk of preterm birth. Infants of women with psychiatric disorders had lower birth weight and higher percentage of birth weight below the 10th centile for gestational age (30%) than infants of healthy mothers (5%). Limitations These findings are preliminary and warrant further investigation in larger-scale study; they are limited by the heterogeneity of psychiatric diagnoses. Conclusions Maternal psychiatric disorders are associated with a lower birth weight, but the effect is unlikely to be due to abnormal utero-placental or feto-placental vascularisation. Further studies should investigate other possible causes of lower birth weight associated with maternal psychiatric disorders.

Background Patients with bipolar disorder may be at greater risk for overweight and obesity than individuals in the general population. This risk may be due to the illness itself, to mediating factors (diet, life style) and/or to medications used to treat the disorder. This investigation explores the association between body weight and bipolar illness in drug-naive patients. Methods Weight and height were retrospectively obtained from 76 clinical charts of drug-naive patients with bipolar disorder (DSM-IV-TR). A reference group for comparison was then selected from another psychiatric population (65 patients with obsessive–compulsive disorder) and investigated with the same methodology to estimate their BMI. A second focus was to examine the differences in baseline demographic and clinical characteristics between overweight and non-overweight bipolar patients. Results A total of 40.8% of the patients with bipolar disorder met criteria for obesity or overweight with significant difference in comparison with obsessive–compulsive patients (10.8%). The highest proportions of depression at index episode were in the overweight group (83.3%) with significant difference with the non-overweight patients (58.1%). Limitations Retrospective study. Weight measurement not in euthymic period. Conclusions Overweight is significantly more prevalent in drug-naive patients with bipolar disorder than in another drug-naive psychiatric patients (OCD). In agreement with previous studies, the number of patients experiencing a depressive episode was significantly higher in the overweight than in the non-overweight group. These results suggest that the prevalence of overweight in bipolar patients is also influenced by the illness itself or mediating factors such as diet and life style than by pharmacologic treatment.

The variability in the clinical presentation of dysthymia has given rise to a rich debate in literature, and various hypotheses have been proposed. One is that the clinical presentation differs in relation to age at onset. The aim of the study was to evaluate differences in socio-demographic and clinical characteristics in a sample of patients with dysthymia (DSM-IV), in relation to age at onset.84 consecutive outpatients with a diagnosis of dysthymia (DSM-IV) were studied. All subjects were evaluated by a semistructured clinical interview and the following rating scales: HAM-A, HAM-D, MADRS, Paykel's Interview for Recent Life Events.23.8% of the sample had early-onset (21 yrs) dysthymia. Patients with early-onset disorder were significantly younger at the observation, more frequently female and single. They had a significantly longer duration of illness and in a significantly higher percentage had already received a specialist treatment before admission in the present trial. No differences in the frequency of symptoms were observed. A significantly higher percentage of patients with late-onset disease reported at least one stressful event in the year preceding the onset of dysthymia. A positive history of major depression was significantly more common among the early-onset group; social phobia, panic disorder and conversive disorder were also more frequent in this group. The late-onset patients frequently presented generalized anxiety disorder, substance abuse and somatization disorder.The study is retrospective and enrolls a limited number of cases.The present study agrees with other reports on the differences in clinical presentation of dysthymia according to age at onset. Although they are not actually related to age at onset, some interesting findings emerged in the symptomatological characterization of the disorder, referring to the diagnostic criteria proposed in DSM-IV.