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Introduction Vortioxetine is mainly prescribed as oral tablets, usually starting at 5-10 mg per day, and is well tolerated by most patients. However, some patients may experience side effects, the most common of which is nausea, which occurs in 20.9-31.2% of people treated with doses of 5-20 mg/day (Baldwin et al, J Psychopharmacol. 2016;30:242-52). In some countries, vortioxetine is also available as an oral solution (1 drop = 1 mg), which allows a very slow titration schedule that may improve tolerability. Objectives To evaluate whether vortioxetine oral drop solution, started with 1-2 drops (1-2 mg per day) and increased by 1-2 drops per day to 10-20 drops (10-20 mg), is associated with better tolerability and a lower risk of nausea than that observed with oral tablets started with 5-10 mg per day, while maintaining efficacy. To provide pilot data for the design of a multicentre, prospective study. Methods Retrospective, single-centre, observational study. Participants were 58 consecutive patients (mean age 45 + 17 years, 55.2% female) treated with vortioxetine for a depressive episode. Vortioxetine was initiated and titrated up to 1 drop (1 mg) per day in 58.6% of subjects, and initiated and titrated up to 2 drops in 41.4% of subjects. Tolerability was assessed at all visits. CGI and MADRAS scores were recorded at the following time points: T0-baseline, T1=week 1, T2=week 2, T3=week 4, T4=week 8). Comparisons were made using repeated measures ANOVA with Bonferroni correction. Results Nausea was reported by 8 subjects (13.8%) at T1, 4 subjects (6.9%) at T2, 1 subject at T3 (1.7%) and none at T4. Other adverse reactions (mainly dizziness, pruritus/itching, vomiting, diarrhoea, and xerostomia) were reported by a total of 6 subjects (10.3%) at T1, none at T2 and T3, and 1 subject (1.7%) at T4. The maximum dose administered was 20 mg in 75.9% of patients. No patients discontinued vortioxetine due to adverse events, but vortioxetine was discontinued prior to T4 (8 weeks of treatment) in 2 subjects due to lack of efficacy. The mean CGI at baseline was 4.3 ±0.8. The mean value decreased to 3.9±0.7 at week 1 and to 3.4±0.6, 2.7±0.6, 1.9±0.5 at weeks 2, 4 and 8, respectively. All differences were statistically significant (p

Bipolar disorder (BD) is characterized by recurrent episodes of mania, hypomania, and depression and is often complicated by comorbid substance use disorders (SUDs). Up to 60% of individuals with BD experience SUDs, which exacerbate mood instability and increase the risk of rapid cycling, suicide, and poor clinical outcomes. Current treatment strategies, including lithium and valproate, show limited efficacy in treating both BD and SUD. Psychotherapeutic approaches such as cognitive behavioral therapy (CBT) offer benefits but lack a specific focus on substances such as cannabis and cocaine. Since there is still debate on how to treat this comorbidity, there is a need to find new therapeutic options; this mini-review examines the pharmacological properties of cariprazine and its emerging role in the treatment of comorbid BD and SUD. Cariprazine, an atypical antipsychotic with partial agonism at dopamine D2 and D3 receptors, has shown promise in treating both mood symptoms and cognitive dysfunction in BD. Its unique affinity for D3 receptors, which are involved in motivation and reward processing, may offer advantages in reducing drug craving. Clinical trials indicate that cariprazine effectively treats manic, depressive, and mixed episodes in BD with a favorable side effect profile, particularly at lower doses. Preliminary results suggest its potential to reduce craving and substance use in individuals with co-occurring BD and SUD. Therefore, cariprazine, with its unique pharmacodynamic mechanism, could be further studied for the treatment of BD in comorbidity with SUD. However, evidence on the role of cariprazine in the treatment of SUDs remains limited, based primarily on case reports and animal studies. Further research, including large-scale clinical trials, is needed to determine its full efficacy in this dual diagnosis.

Introduction: Major Depressive Disorder (MDD) is a mental health issue that significantly affects patients' quality of life and functioning. Despite available treatments, many patients continue to suffer due to incomplete symptom resolution and side effects., Areas Covered: This manuscript examines Vortioxetine's role in Major Depressive Disorder (MDD) treatment, highlighting its potential to reshape therapeutic strategies due to its unique Multimodal action and proven broad-spectrum efficacy in multiple depressive domains. A detailed examination of Vortioxetine's pharmacological aspects, including indications, dosage, pharmacodynamics, and pharmacokinetics, is provided, emphasizing its safety and effectiveness. The discussion extends to Vortioxetine's role in acute-phase treatment and maintenance of MDD and its profound impact on specialized depression domains., Expert Opinion: Vortioxetine is distinguished for its novel multimodal serotonin modulation mechanism, showcasing significant promise as an innovative treatment for MDD. Its efficacy, which is dose-dependent, along with a commendable tolerability profile, positions it as a potential leading option for initial treatment strategies. The discourse on dosage titration, particularly the strategy of initiating treatment at lower doses followed by gradual escalation, underscores the approach toward minimizing initial adverse effects while optimizing therapeutic outcomes, aligning with the principles of personalized medicine in psychiatric care.

Introduction: Compared to the general population, people with severe mental illness (SMI) have a poorer health status and a higher mortality rate, with a 10-20-year reduction in life expectancy. Excess mortality and morbidity in SMI have been explained by intertwined components. Inflammatory processes could increase the morbidity and mortality risk in patients with bipolar disorder (BD) because of a bidirectional interaction between BD and conditions related to inflammation. This pilot study aimed to evaluate the relationship between C-Reactive-Protein (CRP) and bipolar disorder severity. Methods: A retrospective observational study was conducted on 61 hospitalized patients with bipolar disorder. CRP was measured at admission to inpatient treatment (T0) and after seven days from the admission (T1). Clinical Global Impression for Depression, Mania and Overall Bipolar Illness were recorded at T0 and T1. Comparisons among the recorded CRP values were determined through the paired t -test. Correlations between CRP and CGI scores were determined through Spearman's correlation coefficient at T0 and T1. Results: A statistically significant decrease in CRP values was observed after 7 days of hospitalization ( p < 0.001) and positive significant correlations emerged between CRP and CGI scores at T0 and T1. Conclusion: Patients admitted to the inpatient unit reported a statistically significant decrease of CRP values during the first 7 days of treatment. Although the direction of the relationship between BP severity and inflammation status continues to remain unclear, this study showed a relationship between the improvement of bipolar disease symptoms and the improvement of the inflammatory marker CRP., Competing Interests: AF is/has been a consultant and/or a speaker and/or has received research grants from Angelini, Apsen, Boheringer Ingelheim, Daiichi Sankyo, Doc Generici, Glaxo Smith Kline, Italfarmaco, Lundbeck, Janssen, Mylan, Neuraxpharm, Otsuka, Pfizer, Recordati, Sanofi Aventis, Sunovion, Vifor. AC is/has been a consultant and/or a speaker for Angelini, Glaxo Smith Kline, Lundbeck, Janssen, Otsuka, Pfizer, Recordati. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Cuomo, Koukouna, Spiti, Barillà, Goracci, Bolognesi and Fagiolini.)

Background: Major depressive disorder (MDD) is a recurrent illness with high rates of chronicity, treatment-resistance, and significant economic impact. S -Adenosylmethionine (SAMe), a molecule that is formed naturally in the human body, has shown antidepressant effects and may expand the available options for treating MDD. This systematic review examines the evidence concerning the efficacy of SAMe as monotherapy or in combination with antidepressants., Methods: A systematic search in Medline, Psychinfo, AMED, and Cochrane Controlled Trials Register was conducted for any reference recorded up to March 2020. Double-blind, randomised controlled trials, comparing the antidepressant efficacy of SAMe to placebo or/and to other antidepressants, were selected. Two authors evaluated each study independently and then, reconciled findings., Results: Eight trials, with a total of 11 arms and 1011 subjects, evaluating the efficacy of SAMe used as monotherapy or as adjunctive therapy (512 individuals), were included in this review. The study duration ranged between 2 and 12 weeks and the daily dose of SAMe varied from 200 to 3200 mg. Five comparisons evaluated the differences between SAMe and placebo and SAMe resulted significantly better than placebo in three of these studies. Four comparisons evaluated the differences between SAMe and other antidepressants (imipramine or escitalopram) and showed no significant difference. One study showed that SAMe was significantly better than placebo in accelerating the response to imipramine from day 4 to day 12, but the mean scores were not statistically different at the day 14 endpoint. One study showed that SAMe combined with serotonin reuptake inhibitors (SSRI) was better than PBO combined with SSRI. The studies reported only mild, transient or non-clinically relevant side effects., Conclusions: The existing trials of SAMe, used as monotherapy or add on to another antidepressants, have shown encouraging and generally positive results. However, more evidence is necessary before definitive conclusions can be drawn. Larger, double-blind randomised controlled studies are warranted to confirm the antidepressant effectiveness of SAMe., Competing Interests: Competing interestsAndrea Fagiolini is/has been a consultant and/or a speaker and/or has received research grants from Allergan, Angelini, Apsen, Boehringer Ingelheim, Doc Generici, FB-Health, Italfarmaco, Janssen, Lundbeck, Mylan, Otsuka, Pfizer, Recordati, Sanofi Aventis, Sunovion, Vifor. Alessandro Cuomo is/has been a consultant and/or a speaker and/or has received research grants from Angelini, Janssen, Lundbeck, Otsuka, and Pfizer. The other authors declare no conflict of interest., (© The Author(s) 2020.)

Introduction: Few studies have investigated the effects of efficacious psychotherapy on structural alterations of discrete brain regions associated with posttraumatic stress disorder (PTSD). We therefore proposed to evaluate the neurobiological effects of eye movement desensitization and reprocessing (EMDR) on 19 patients with drug-naïve PTSD without comorbidity, matched with 19 untreated healthy controls., Methods: We administered the Clinician Administered PTSD Scale (CAPS) and conducted brain MRI measurements (with Optimized Voxel-Based Morphometry). Patients received 12 EMDR sessions over three months. Then patients and controls were reassessed., Results: At baseline, grey matter volume (GMV) differed significantly between patients and controls (F 1,35 =3.674; p=.008; η 2=.298). Analyses of 3-month scans showed no changes for controls, while significant changes were highlighted for patients post-EMDR, with a significant increase in GMV in left parahippocampal gyrus, and a significant decrease in GMV in the left thalamus region. The diagnosis of PTSD was effectively eliminated in 16 of 19 patients, reflected in a significant improvement on the CAPS (t(35)=2.132, p<.004)., Discussion and Conclusions: Results indicated post-EMDR changes for patients in brain morphology. We discuss whether EMDR’s mechanism of action may work at the level of the thalamus, an area implicated in PTSD pathology.

Objectives: To identify possible differences, in terms of duration and severity of Post-Traumatic Stress Disorder, between victims of terrorist attacks and subjects who underwent other types of traumatic events., Methods: A sample of subjects suffering from PTSD was selected. After a clinical interview aimed at the collection of anamnestic data, CAPS to confirm the diagnosis of PTSD and DTS to assess frequency and severity of post-traumatic symptoms were administered. One-way ANOVA was used in order to compare the differences in the parameters analysed through the DTS scales and its clusters between the victims of terrorist attacks and patients undergone other traumatic events., Results: The duration of PTSD was 258 +/ - 144.9 months for people who underwent a terrorist attack and 41.6 +/ - 11.8 months for victims of other traumatic events. As regards the severity of the disorder, the total score of the DTS scale was 65.6 +/ - 26.9 in victims of terrorist attacks and 78.2 +/ - 28.2 in people who undergone other traumatic events. However, the difference was not statistically significant; Avoidance and Hypervigilance clusters showed an important statistical significance., Conclusions: No significant differences are present in terms of severity, showing that PTSD is a disabling disorder regardless the type of event that triggers it; however, a significant difference in terms of duration of the disorder leads to reflec on the importance of an early diagnostic process aimed toward the victims of terrorism, in order to avoid the risk of chronicity and progression to other psychiatric disorders such as depression.

Sexual dysfunctions may have a significant effect on the quality of life, but are unreported and under-diagnosed. A review of recent literature highlights the correlation between dysfunction and a decreased quality of life in people with psychiatric comorbidity, and explores several aspects impacting care, from following the patient to pharmacological and non-pharmacological treatments. Sexual dysfunctions (SD) have been shown to be prevalent, but under-diagnosed and un-dertreated because of communication barriers between patients and physicians. Pharmacogenic and morbogenic causes of sexual problems are often difficult to differentiate. Psychiatric diseases may increase the risk of SD, and SD may further exacerbate psychiatric problems, suggesting a bi-directional relationship. Their effective treatment frequently involves combination of elements from psychotherapy, and behavioral along with pharmacotherapeutic intervention, if needed. The persistence of sexual problems has significant negative impact on patient's satisfaction and adherence with the treatment, quality of life and partnership. Routine assessment of sexual functioning needs to be integrated into ongoing care to identify and address problems early. If sexual dysfunction is ignored it may maintain the psychiatric disorder, compromise treatment outcome and lead to non-adherence and compromise treatment outcome.

Objectives: The overlap between symptoms of PTSD and MDD is substantial. PTSD symptoms arise after a traumatic experience and the trauma is present in all of the diagnostic clusters. In individuals who have experienced a trauma a long time before, it is difficult to establish the exact moment of onset of their symptoms in relation to the trauma suffered. We proposed to raise awareness among operators who may encounter this problem, with the aim of providing them with valuable help in order to achieve a correct differential diagnosis., Methods: A sample of subjects suffering from PTSD without comorbidity was assessed to confirm the diagnosis and the severity of post-traumatic symptoms. The Kruskal-Wallis test was used to compare any modifications in the parameters analyzed through the Davidson Trauma Scale with the presence and severity of depressive symptoms as evaluated by the Hamilton-D scale., Results: Half of the PSTD patients recruited showed values of HAM-D > 18, although an active Major Depressive Episode was clinically excluded. Symptom of "numbing", despite being different from the apathy experienced in depression, is identified as a depressive symptom by the HAM-D., Conclusions: Giving prevalence to depressive symptoms may be misleading for diagnosis and may ultimately result in inappropriate treatment.

Objectives: Seasonal trends were demonstrated in reproduction and sexual activity. Through the secretion ofmelatonin the pineal gland plays an important role in the neuroendocrine control of sexual function and reproductive physiology. We hypothesized that inhibition of the pineal gland activity through a light treatment may favorably affect sexual function., Methods: We recruited 24 subjects with a diagnosis of hypoactive sexual desire disorder and/or primary sexual arousal disorder. The subjects were randomly assigned to either active light treatment (ALT) or placebo light treatment (L-PBO). Participants were assessed during the first evaluation and after 2 weeks of treatment, using the Structured Clinical Interview for Sexual Disorders DSM-IV (SCID-S) and a self-administered rating scale of the level of sexual satisfaction (1 to 10). Repeated ANOVA measures were performed to compare the two groups of patients. Post-hoc analysis was performed by Holm-Sidak test for repeated comparisons. Results. At baseline the two groups were comparable. After 2 weeks the group treated with Light Therapy showed a significant improvement in sexual satisfaction, about 3 times higher than the group that received placebo, while no significant improvement was observed in the group L-PBO. Conclusions. Our results confirm a potentially beneficial effect of Light Therapy on primary sexual dysfunction. In the future, we propose to correlate clinical findings with testosterone levels pre/post treatment.

Aim. The Functioning Assessment Short Test (FAST) is a useful instrument for the assessment of overall functioning of people with bipolar disorder, showing good psychometric properties. The aim of this study is to validate the Italian version of FAST. Methods. Translation and back-translation of the original FAST Spanish version were performed. Participants with bipolar disorder (n = 132) and healthy controls (n = 132) completed the FAST as a part of an assessment package including the Montgomery-Asberg Depression Rating Scale and the Young Mania Rating Scale. Internal consistency, inter-rater reliability, construct and discriminant validity were assessed. Results. The FAST Italian version showed good internal consistency, inter-rater reliability and discriminant validity. The cut-off discriminating patients from controls was 15, with a sensitivity of 0.79 and a specificity of 0.80. Principal component analysis with oblique rotation showed factor loadings consistent with the a priori structure of the instrument. Conclusions. This study confirmed the psychometric properties of FAST and extended its generalization and validity to the Italian population.

Introduction: Trazodone is an antidepressant belonging to the class of serotonin receptor antagonists and reuptake inhibitors. It is approved by the FDA for the treatment of depression. Insomnia is the most frequent reason for prescription of trazodone. It has also been proven useful in the treatment of anxiety disorders. Other off-label uses include the treatment of bulimia, benzodiazepine/alcohol dependence, fibromyalgia, central nervous system degenerative diseases (behavioral disorders in dementia and other organic disorders), schizophrenia, chronic pain disease and diabetic neuropathy, sexual dysfunction., Areas Covered: This paper evaluates trazodone's efficacy and safety in its off-label uses. It also discusses the possibility that a combination of trazodone with SSRIs may prevent or treat some of the SSRI side effects, such as anxiety, insomnia and sexual dysfunction, in addition to synergically increasing SSRIs' antidepressant activity., Expert Opinion: Few clinical trials have been conducted to evaluate trazodone's efficacy in the treatment of the diseases and symptoms for which it is often used in clinical practice. More studies are necessary to investigate possible new therapeutic indications, and to scientifically demonstrate the risk/benefit ratio for the many conditions for which trazodone is used, but not approved by the FDA.

Unlabelled: Strong evidences support use of EMDR in patients suffering from post-traumatic stress disorder (PTSD)., Aim: To evaluate clinical and neurobiological-structural efficacy of EMDR on drug-naïve PTSD without comorbidity., Materials and Methods: We made clinical evaluation and hippocampal volume measurement by MRI on 29 subjects suffering from PTSD and on 30 healthy control-subjects. Then, patients were treated with EMDR and after three months of psychotherapy the clinical evaluation and the MRI exam were replied., Results and Discussion: Our results demonstrated that the diagnosis of PTSD was no more possible on all the patients who terminated the psychotherapy (n=18). At the same time, all the patients showed an average increase of 6% in hippocampal volumes., Conclusions: Our reaserach suggests that EMDR treatment correlates not only with a significant improvement of symptoms of PTSD, but also with a significant increase of hippocampal volumes.