Tolerability of vortioxetine compared to selective serotonin reuptake inhibitors in older adults with major depressive disorder (VESPA): a randomised, assessor-blinded and statistician-blinded, multicentre, superiority trial.

Background: Major depressive disorder (MDD) is prevalent and disabling among older adults. Standing on its tolerability profile, vortioxetine might be a promising alternative to selective serotonin reuptake inhibitors (SSRIs) in such a vulnerable population. Methods: We conducted a randomised, assessor- and statistician-blinded, superiority trial including older adults with MDD. The study was conducted between 02/02/2019 and 02/22/2023 in 11 Italian Psychiatric Services. Participants were randomised to vortioxetine or one of the SSRIs, selected according to common practice. Treatment discontinuation due to adverse events after six months was the primary outcome, for which we aimed to detect a 12% difference in favour of vortioxetine. The study was registered in the online repository clinicaltrials.gov (NCT03779789). Findings: The intention-to-treat population included 179 individuals randomised to vortioxetine and 178 to SSRIs. Mean age was 73.7 years (standard deviation 6.1), and 264 participants (69%) were female. Of those on vortioxetine, 78 (44%) discontinued the treatment due to adverse events at six months, compared to 59 (33%) of those on SSRIs (odds ratio 1.56; 95% confidence interval 1.01-2.39). Adjusted and per-protocol analyses confirmed point estimates in favour of SSRIs, but without a significant difference. With the exception of the unadjusted survival analysis showing SSRIs to outperform vortioxetine, secondary outcomes provided results consistent with a lack of substantial safety and tolerability differences between the two arms. Overall, no significant differences emerged in terms of response rates, depressive symptoms and quality of life, while SSRIs outperformed vortioxetine in terms of cognitive performance. Interpretation: As opposed to what was previously hypothesised, vortioxetine did not show a better tolerability profile compared to SSRIs in older adults with MDD in this study. Additionally, hypothetical advantages of vortioxetine on depression-related cognitive symptoms might be questioned. The study's statistical power and highly pragmatic design allow for generalisability to real-world practice. Funding: The study was funded by the Italian Medicines Agency within the "2016 Call for Independent Drug Research".

The Impact of Covid-19 Pandemic on Mental Health Services: A Comparison Between First Psychiatric Consultations Before and After the Pandemic.

Objective: A high rate of onset or exacerbation of several mental disorders has been observed during the COVID-19 pandemic. However, the risk contributing to mental distress during the pandemic remains unclear. The study aims to evaluate the risk of the onset of mental disorders by comparing the number of requests for the first psychiatric consultation before and after the COVID-19 pandemic at the psychiatric outpatient services of Varese, a small town in Northern Italy. Method: This observational retrospective study aims to compare the requests for the first psychiatric consultation at the outpatient services of Varese during the 14-month period before COVID-19 pandemic (from 1st January 2019 to 28th February 2020) versus the 14-month period after the pandemic (from 1st March 2020 to 31st May 2021) extracted from the server SIPRL-Psicheweb database (Sistema Informativo della Psichiatria, Lombardy Region). For each patient, socio-demographic features and clinical data (psychiatric diagnosis, psychiatric comorbidities, previous psychiatric records, and previous hospitalization in the psychiatric ward) were collected. Results: Three hundred ninety-five consultations were made during the pre-COVID period and 346 during the post-COVID period. No statistically significant difference was found between the number of first consultation requests in the two periods evaluated but a slight decrease in the total number during the pandemic period (395 vs 346; p=0.07) can be noticed. In the subjects of the pre-COVID group, a statistically significant association was detected with no previous psychiatric records ("absent") and with stressor-related disorders. In the post-COVID group, a statistically significant correlation between "present" previous records and anxiety-depressive disorders emerged. Conclusions: It has been observed that anxiety-depressive disorders increased in the post-COVID-19 period compared to the pre-COVID-19, instead of stressor-related disorders. This might be because stressor-related disorders may be treated by general practitioners with no psychiatric interventions. Most of the first consultations during the period of the COVID-19 pandemic were for patients who already had contact with psychiatric services.The study shows an increasing request for care by more severe patients in the first phase of the SARS-CoV-2 pandemic. Further research is needed to investigate the long-term impact of the COVID-19 pandemic on emergency departments and hospital services.

Efficacy of short-term psychodynamic psychotherapy (STPP) in depressive disorders: A systematic review and meta-analysis.

INTRODUCTION: Depression is one of the leading diseases globally. It can severely interfere with daily and occupational functioning of people affected. Both pharmacological interventions and psychotherapy are used for adult depression. The aim of the review is to evaluate the efficacy of short-term psychodynamic psychotherapy (STPP) by comparing STPP with different types of interventions. MATERIALS AND METHODS: A systematic review with meta-analysis on the efficacy of STPP in depressive disorders was performed. RESULTS: Meta-analysis findings confirm the superiority of STPP versus no interventions. The average effect size of depressive symptoms severity at the end of the treatment is -0.91 (95% CI: -1.49 - -0.33) in favor of STPP, while for clinical improvement of depressive symptoms is -0.78 (95% CI: -1.56 - 0.01). Results confirm a clear superiority of STPP to usual treatments unstructured. A mild superiority of efficacy of STPP on support psychotherapy emerged. Comparison of the efficacy of STPP vs cognitive-behavioral psychotherapy (CBT) shows little superior in case of STPP. No substantial differences in efficacy in case of STPP than control interventions emerged. Antidepressant therapy is resulted to be slightly more effective to STPP. DISCUSSION: While all the other results confirm current literature, this review shows no superiority of combined treatment than STPP only. LIMITATIONS: The review has some limitations such as the lack of moderation analysis and the high heterogenicity of the type of the studies. CONCLUSIONS: The results confirm the efficacy of STPP in depressive disorders and endorse the guidelines of National Institute for Health and Clinical Excellence (NICE).

Assessing Mental Pain as a Predictive Factor of Suicide Risk in a Clinical Sample of Patients with Psychiatric Disorders.

According to contemporary suicidology, mental pain represents one of the main suicide risk factors, along with more traditional constructs such as depression, anxiety and hopelessness. This work aims to investigate the relationship between the levels of mental pain and the risk to carry out suicide or suicide attempt in the short term in order to understand if a measurement of mental pain can be used as a screening tool for prevention. For this purpose, 105 outpatients with psychiatric diagnosis were recruited at the university hospital of Varese during a check-up visit and were assessed by using psychometric scales of mental pain levels, hopelessness, anxiety and depression. Clinical and sociodemographic variables of the sample were also collected. A period of 18 months following the recruitment was observed to evaluate any suicides or attempted suicides. Subjects numbering 11 out of 105 committed an attempted suicide. From statistical analyses, high values of the Beck Depression Inventory (BDI-II), Mental Pain Questionnaire (OMMP) and Hamilton Rating Scale for Depression (HAM-D) scales showed a significant association with the risk of carrying out a suicide attempt and, among these, OMMP and BDI-II showed characteristics of good applicability and predictivity proving suitable to be used as potential tools for screening and primary prevention of suicidal behavior.

Efficacy and tolerability of therapies set under pharmacogenetic tools suggestions: A systematic review with meta-analysis about mood disorders.

BACKGROUND: Bipolar Disorder (BD) and Major Depressive Disorder (MDD) have a huge impact on functioning and quality of life; moreover, they are linked to extensive direct and indirect costs. This systematic review with meta-analysis aims to evaluate the utility of pharmacogenetic tests (PGT) in terms of efficacy and tolerability into the routine clinical treatment of mood disorders. MATERIALS AND METHODS: The first part of the review is a qualitative overview of the PGTs used in the included studies. The second part aims to compare, in terms of efficacy and tolerability, patients affected by BD and MDD treated as usual (TAU), according to the clinicians' prescribing attitude, versus patients whose psychopharmacological treatments were set up following the PGT suggestions. RESULTS: 6 studies on MDD and 2 studies on BD were included. Regarding MDD, the meta-analysis shows a significantly higher number of patients achieving better outcome in terms of efficacy, through the evaluation of response rate and remission rate at the HDRS (Hamilton Depression Rating Scale) in the group of patients treated under the PGT suggestions; regarding BD the meta-analysis does not show any significant difference in terms of efficacy. In terms of adverse events, the available data suggest promising results about the utility of PGT to set more tolerated therapies. CONCLUSIONS: Although the limited number of studies, results confirm the importance of PGT in setting up psychopharmacological therapies as a support to clinicians' choices.

The North Italian innovative project for common psychiatric disorders: Evaluating the output of a treatment model of an outpatient clinic for anxiety and depression.

Depressive disorders were considered the first causes of disability worldwide as early as 2018. The outpatient clinic for anxiety and depression at the University Hospital of Varese represents a service that fully responds to the growing number of requests. Approximately 1,350 medical records have been opened from 2010 to December 2021. The most frequent presenting diagnoses included anxiety disorders (36.8%), severe stress and maladaptation syndromes (35.5%), and depressive episodes (18%). The outpatient clinic has proved to be a model with great impact on users offering a range of diagnostic and therapeutic offers responding to the requests of the community.

Post-traumatic stress following total hysterectomy for benign disease: an observational prospective study.

PURPOSE: Over the last decade, there has been growing interest in the psychophysical integrity of surgical patients in the context of healthcare events. In the present study, we aimed to evaluate the incidence rate of postoperative distress symptoms, namely post-traumatic stress disorder (PTSD), following total hysterectomy for benign disease. We also investigated possible associations between sociodemographic characteristics, clinical outcomes, anxiety, depression, and PTSD. METHODS: We prospectively enrolled 100 consecutive patients who underwent total hysterectomy for benign disease between 01/01/2019 and 15/04/2019. Demographic and surgical-related characteristics have been registered. The Hospital Anxiety and Depression Scale (HADS) questionnaire was administered preoperatively (Time1), postoperatively (Time2), and at follow-up clinical evaluation, between two and three months after surgery (Time3). PTSD was defined based on the results of the Post-traumatic Stress Disorder Checklist for DSM-5 (PCL-5) at Time3. RESULTS: At Time3, the median PCL-5 score was 12,8 (0-70), and 16.4% of patients had PTSD symptoms (PCL-5 > 33). No correlation between sociodemographic or gynecologic characteristics and PTSD was detected. A significant association between depression (HADS > 8) at Time2 (p = 0.002) and Time3 (p < 0.001) and PTSD symptoms was shown. CONCLUSION: Hysterectomy for benign disease is associated with a non-negligible risk of PTDS; the use of the HADS questionnaires might be useful to select patients who might benefit from dedicated psychological support.

Resilience, Cardiological Outcome, and Their Correlations With Anxious-Depressive Symptoms and Quality of Life in Patients With an Implantable Cardioverter Defibrillator.

Background: Resilience is proven as a protective factor against the development of psychiatric disorders, and it has gained clinical relevance in the development and progression of cardiovascular pathology. The authors performed a longitudinal study on patients with implantable cardioverter defibrillator (ICD) with the primary aim to highlight the possible existence of a correlation between individual resilience capacity, depressive and anxiety symptoms, and quality of life in terms of outcomes. The secondary aim was to analyze the differences between patients with major cardiac events in the follow-up and patients without cardiac events with respect to the previous variables. Materials and Methods: A total of 80 patients enrolled in the Cardiology Unit were evaluated at T0 and during the follow-up through the following scales: the 14-item Resilience Scale (RS-14), the Hospital Anxiety and Depression Scale (HADS), and the World Health Organization Quality of Life-Brief Version (WHOQOL-Bref). Results: A significant linear correlation between resilience and all the areas of quality of life at T0, T1, and T2 emerged. A negative correlation between resilience and anxiety and depressive symptoms emerged, as well as between depression and anxiety and quality of life. Patients with cardiac events during the follow up have shown a worse quality of life and the onset of anxiety-depressive symptoms over time, without changes to the resilience scores. Patients without cardiac events showed an increasing trend in resilience scores. Discussion: Given the speed and simplicity of use of the RS-14 scale, it seems promising to further investigate the real clinical usefulness of this instrument in the cardiology field.

Selective Serotonin Reuptake Inhibitors and Nutraceutical Combination in Major Depression Disorder: A Case-Control Study.

Introduction: Major depressive disorder (MDD) is a primary cause of disability in adults, affecting daily functioning and decreasing quality of life. The focus on the role of nutraceuticals as adjunctive treatments to improve antidepressant response is paying growing interest. The study aims to compare the antidepressants response in the utilization of selective serotonin reuptake inhibitors (SSRIs) versus a combination of SSRIs and nutraceutical supplements based on S-Adenosyl methionine (SAMe), N-acetylcysteine (NAC) and folate in terms of efficacy and tolerability. Methods: A case-control study was carried out between March 2018 and September 2019. Cases and controls were evaluated through the following scales: Hospital Anxiety Depression Scale (HADS); Clinical Global Impression (CGI); Patient Global Impression of Improvement (PGI-I); Antidepressant Adverse Events checklist (AES). Results: A significant difference between the two groups of patients emerged at T1 in the HADS-A (p = 0.004) score and in the CGI score (p = 0.01), due to a major improvement in patients with a nutraceutical co-prescription. At T3 a significant statistical difference emerged, showing a greater improvement at HADS-D in the case group (p = 0.006), confirmed by a higher remission rate in patients taking a nutraceutical co-prescription. No differences in terms of adverse events emerged. Conclusion: This study shows promising data about the role of nutraceuticals as adjunctive treatment in major depressive disorder to improve SSRIs efficacy, with good tolerability. More data are needed to confirm these results, particularly about the role of nutraceuticals to decrease the latency of SSRIs response.

Long Acting Injectables and their Correlation with Subjectivity in Schizophrenia Spectrum Disorder.

Nowadays, mental illness can no longer be considered as a mere list of symptoms corresponding to localized brain dysfunctions but rather as a disturbance of the patient's subjectivity. Thus, a solid, qualitative study of patients' subjectivity could represent a useful tool in the complex evaluation of efficacy of pharmacotherapy in schizophrenic persons. In this perspective, authors performed a phenomenological oriented investigation on 49 patients, diagnosed with schizophrenia spectrum disorder, who were receiving long-acting injectable (LAI) antipsychotic therapy. From data analysis, authors found a positive correlation between general psychopathology and the use of LAI antipsychotic therapies. The present study highlighted the necessity of a careful investigation of patients' subjectivity in a phenomenological way as an irreducible part of both psychopathological and psychopharmacological matters.

[Pharmacogenetic testing in acute and chronic pain: a preliminary study]. / Test farmacogenetici nel dolore acuto e cronico: uno studio preliminare.

SUMMARY: Background. Pain is one of the most common symptoms that weighs on life's quality and health expenditure. In a reality in which increasingly personalized therapies are needed, the early use of genetic tests that highlight the individual response to analgesic drugs could be a valuable help in clinical practice helping to reduce response times, to achieve a good level of analgesia and to reduce the risk of side effects and adverse events. The study aims to confront the clinical response to analgesic drugs with the result of pharmacogenetic testing in patients with persistent pain. Methods. This preliminary study compares the genetic results of pharmacological effectiveness and tolerability analyzed with a Pharmacogenetic Test with the results obtained in clinical practice in 5 patients suffering from acute and chronic pain. Results. Regarding the genetic results of the 5 samples analyzed, 2 reports were found to be completely comparable to what found in clinical practice, while 3 reports showed that the profile of tolerability and effectiveness were partially discordant. Conclusions. In light of the data, not completely overlapping with results observed in clinical practice, further studies would be appropriate in order to acquire more information on the use of the PGT in clinical practice.

Oral Antipsychotic Versus Long-Acting Injections Antipsychotic in Schizophrenia Spectrum Disorder: a Mirror Analysis in a Real-World Clinical Setting.

Despite mixed results found in literature, long-acting injectable antipsychotics (LAIs) should offer better efficacy and tolerability, compared to oral antipsychotics due to improved adherence and more stable pharmacokinetics. From this perspective, authors evaluated 153 patients, diagnosed with Schizophrenia Spectrum Disorder and residing in the province of Varese (Italy), in order to compare oral antipsychotics' and LAIs' efficacy in terms of accesses to emergency room, number and length of hospitalizations. Data analysis showed a substantial reduction in all considered variables after the introduction of long-acting therapy, especially for those who received LAI treatment from disease's onset. Authors emphasised the use of long-acting antipsychotic as first-line treatment in the early stage of disease, since available data seem to confirm the hypothesis of a better prognosis for patients who received antipsychotic depot from illness's onset.

Hospitalized Patients with Medically Unexplained Physical Symptoms: Clinical Context and Economic Costs of Healthcare Management.

Medically Unexplained Physical Symptoms (MUPS) are physical symptoms without a medical explanation. This study collected data from hospitalized patients presenting MUPS, aiming to draw a clinical and socio-demographic profile of patients with MUPS, to explore psychopathological correlations of Somatic Symptoms Disorder (SSD) diagnosis, and to estimate economic costs related to hospital management for MUPS. The cross-sectional study consisted in the evaluation of data referring to hospitalized patients admitted between 2008 and 2018 in a teaching hospital in Northern Italy. A total of 273 patients presenting MUPS have been hospitalized. The sample showed a prevalence of female, married and employed patients. The most frequent wards involved are Neurology, Internal Medicine and Short Unit Stay. The most common symptoms found are headache, pain, syncope and vertigo. There is no evidence that a history of medical disease is associated with a diagnosis of SSD. A personality disorder diagnosis in patients with MUPS was associated with increased probability of having a diagnosis of SSD. A marginally significant positive association emerged with anxiety disorders, but not with depressive disorder. The overall estimated cost of hospitalization for patients with MUPS is 475'409.73 €. The study provides the investigation of a large number of patients with MUPS and a financial estimate of related hospitalization costs.

Resilience and recovery style: a retrospective study on associations among personal resources, symptoms, neurocognition, quality of life and psychosocial functioning in psychotic patients.

Background: Personal resources have been identified as important factors in predicting patient healing or symptoms control in schizophrenia. This observational retrospective study aims to explore the influence of resilience and recovery style on the modalities of clinical presentation of the disease, as well as individual functioning and quality of life. Methods: Participants were patients affected by schizophrenia spectrum disorders assessed at different mental health facilities. The rating scales considered are the following: Resilience Scale 10-items (RS); Recovery Style Questionnaire (RSQ); Montreal Cognitive Assessment (MoCA); Schizophrenia Quality of Life Scale (SQLS); Life Skills Profile (LSP); Positive and Negative Syndrome Scale (PANSS). Results: Forty-four patients fulfilled the inclusion criteria. The mean age was 46 years; the average length of the history of the disease at recruitment was 23 years with an average age at first episode of psychosis (FEP) of 23 years. General psychopathology, neurocognition, and integration recovery style can predict psychosocial functioning and explain ~54% of the LSP variance; RS total score and PANSS general psychopathology score can predict and explain ~29% of the LSP variance. A negative association between PANSS general psychopathology and LSP total score supports the need to reduce first the symptomatology, and then successfully apply other types of interventions. A strong positive association between neurocognition and life functioning was detected, showing that deficits in neurocognition have proved to be important predictors of the functional outcome. Integration was also proven to be significantly associated with a good functional outcome. Psychotic symptoms turn out to be a negative predictive factor, whereas resilience can be hypothesized as a protective factor. Conclusions: Resilience and recovery style "integration" can be considered as two complementary predictive resources for a good outcome; this result supports the need to set up personalized treatments, based on the characteristics of the patients.

Pharmacogenetic Tests in Reducing Accesses to Emergency Services and Days of Hospitalization in Bipolar Disorder: A 2-Year Mirror Analysis.

Despite the enormous costs associated to mood disorders', few studies evaluate potential cost saving from the use of pharmacogenetic tests (PGT). This study compares 12 months before the execution of the PGT versus 12 months after, in terms of number and days of hospitalization and accesses to emergency services, in a sample of 30 patients affected by bipolar disorder. Secondarily, the study gives an economic value to the data based on the diagnosis-related group (DRG). Patients included in the study were required to be aged ≥18 years, sign an informed consent, have a score of Clinical Global Impression item Severity (CGIs) ≥3, and have a discordant therapy compared to the PGT in the 12 months preceding it and a therapy consistent with it for the following 12 months. Cost saving has been evaluated by paired t-tests in a mirror analysis. Statistically significant differences in all the comparisons (p < 0.0001) emerged. Important cost saving emerged after the use of PGT (€148,920 the first year versus €39,048 the following year). Despite the small sample size and lack of a control group in this study, the potential role of PGT in cost saving for the treatment of bipolar disorder treatment emerged. To confirm this result, larger and clinical trials are needed.

Pharmacogenetic Testing in Acute and Chronic Pain: A Preliminary Study.

Background and Objectives: Pain is one of the most common symptoms that weighs on life's quality and health expenditure. In a reality where increasingly personalized therapies are needed, the early use of genetic tests that highlights the individual response to analgesic drugs could be a valuable help in clinical practice. The aim of this preliminary study is to observe if the therapy set to 5 patients suffering of chronic or acute pain is concordant to the Pharmacogenetic test (PGT) results. Materials and Methods: This preliminary study compares the genetic results of pharmacological effectiveness and tolerability analyzed by the genetic test Neurofarmagen Analgesia, with the results obtained in clinical practice of 5 patients suffering from acute and chronic pain. Results: Regarding the genetic results of the 5 samples analyzed, 2 reports were found to be completely comparable with the evidences of the clinical practice, while in 3 reports the profile of tolerability and effectiveness were partially discordant. Conclusion: In light of the data not completely overlapping with results observed in clinical practice, further studies would be appropriate in order to acquire more information on the use of Neurofarmagen in routine clinical settings.

Paroxetine versus Vortioxetine for Depressive Symptoms in Postmenopausal Transition: A Preliminary Study.

Background: The impact of menopause is a consequence of social, physical and mental changes; hormonal changes play an important role in inducing an increased risk of developing depressive symptoms. It is essential to treat mood and vasomotor symptoms and to prevent their onset to promote an improvement in the quality of life, both in terms of clinical and psychological conditions. Objective: This observational study aims to compare paroxetine and vortioxetine in a sample of patients affected by postmenopausal depression attending the Anxiety and Depression Clinic in terms of: efficacy in determining clinical remission (HDRS ≤ 7) and tolerability; improvement of autonomic and cognitive symptoms. Methods: 39 female outpatients with a diagnosis of Postmenopausal Depression (according to DSM-5 criteria) were evaluated as the routine clinical practice through the following scales: Hamilton Depression Rating Scale (HDRS); Menopause Rating Scale (MRS); Montreal Cognitive Assessment (MoCA); Antidepressant Side-Effect Checklist (ASEC); data from/of baseline, after 8 weeks and 12 weeks were recorded. Results: Both antidepressants resulted to be effective in clinical remission (HDRS ≤ 7) without statistical differences between the two groups (p = 0.3), although paroxetine showed a faster remission than vortioxetine (p = 0.01). Autonomic symptoms showed a higher improvement in the vortioxetine group (p = 0.002). Paroxetine group referred insomnia and sexual problems while patients taking vortioxetine referred diarrhoea and palpitations. Data show a superiority of cognitive performance in the Paroxetine group (p = 0.005), contrary to what stated in literature. Conclusions: Data are related to a small sample retrospectively assessed trough a 6-month observation period. Thus, the preliminary results need further research to be confirmed.

Medically Unexplained Physical Symptoms in Hospitalized Patients: A 9-Year Retrospective Observational Study.

Introduction: "Medically Unexplained Physical Symptoms" (MUPS) defines a subgroup of patients presenting physical symptoms of unclear origin. The study aims to profile clinical and socio-demographic characteristics of patients with MUPS. Materials and Methods: This 9-years observational retrospective study assesses all patients admitted between 2008 and 2016 in the divisions of neurology and gastroenterology. Socio-demographic and clinical variables were evaluated: gender, age, diagnosis or diagnostic hypothesis, presence of psychiatric comorbidities, psychiatric evaluation, pharmacological treatment, number of admissions/visits. Results: Among 2,479 neurological patients 10.1% presented MUPS. Patients were more frequently women (63.5%), with a mean age of about 50 years. Reported symptoms were headache (22.6%), seizures (8.7%), vertigo (5.9%), fibromyalgia (5.5%), paresthesia (5.1%), visual disturbances (5.1%), amnesia (3.9%). The diagnosis was somatoform disorder in 6.3% of cases, conversion disorder in 2.7%, and somatic symptom disorder in 1.5% only. 2,560 outpatients were evaluated in gastroenterology division. 9.6% (n = 248) of patients had MUPS; 62.1% of them were women. The most affected age group ranged between 15 and 45 years. The most frequent diagnoses were functional abdominal pain (50%), dysmotility-like dyspepsia (26.6%), irritable bowel syndrome (10.4%), meteorism of unknown cause (2.4%), hiccup (1.6%), burning mouth syndrome (1.2%). No patients received a diagnosis of somatic symptom disorder. Discussion: Patients with MUPS are more often women, of middle age, with self-referred specific symptomatology. While neurological patients received a diagnostic-therapeutic approach in line with the literature, gastroenterological patients mainly received antipsychotics. A more comprehensive assessment and a development of psychoeducational interventions are needed to improve patients' quality and quantity of life.

Efficacy and Tolerability of Two Different Kinds of Titration of Paroxetine Hydrocloride Solution: an Observational Study.

Background: Depressive disorders are expected to be the second highest cause of morbidity in the world until few years. Moreover, patients with depression frequently show many side effects and low compliance to therapy. To find a more tolerated and more efficacy therapy is a growing need. Objective: This observational study investigates the efficacy, safety and tolerability of paroxetine hydrochloride comparing slow versus standard titration in a population affected by Depressive Disoders (according to DSM 5). Methods: 186 outpatients were assessed throught the following scales: Hamilton Depression Rating Scale (HDRS) for depression and World Health Organization Quality of Life Scale Bref for the perceived quality of life (WHOQOL BREF). Treatment-emerged Adverse Events (TEAEs) were recorded throught self-reports. Statystical analysys was performed by GraphPad Prism Version 5.1. Results: The efficacy of paroxetine was confirmed in both titrations by the number of clinical remitters (HDRS ≤ 7 at 12 weeks for 53% of the standard titration group and 58% of the slow titration group), without differences. About safety and tolerability there were more frequent TEAEs among the standard titration group (p < 0.01). Comparing WHOQOL BREF between the two groups at the recruitment and at the twelth week emerged a statistically significant difference (p = 0.003), with highest scores reached in slow titration group. Conclusions: Although the short observation period is an evident limit, this study is consistent to the literature about the efficacy of both titrations of paroxetine to improve depression and shows promising results about the increased tolerability of paroxetine slow titration.