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1.
Psychiatry Res ; 339: 116064, 2024 Jun 27.
Article in English | MEDLINE | ID: mdl-38981412

ABSTRACT

The positive effects of resilience on psychological distress has been found in previous studies in samples not including the seriously mentally ill. The present study aimed to investigate the course of psychological distress and resilience in the first two years of the Covid-19 pandemic in patients with severe mental illness (SMI) and major depressive disorder without psychotic features (MDD) compared to healthy control subjects. 141 patients with SMI or MDD who had been admitted to a psychiatric ward in Tyrol (Austria) or South Tyrol (Italy) in 2019 and 584 community controls participated in a longitudinal online survey. Next to collecting sociodemographic data, psychological distress was evaluated using the Brief Symptom Checklist (BSCL) and resilience by the 13-Item Resilience Scale (RS-13). Psychological distress was consistently significantly higher while resilience was consistently significantly lower among both patient groups compared to healthy controls. In the patient samples, those with MDD consistently exhibited a significantly higher prevalence and level of psychological distress and significantly lower resilience. Resilience had a moderating effect on psychological distress especially in the MDD group. Our results suggest that MDD patients represent a particularly vulnerable group and findings imply that these patients would profit the most from trainings fostering resilience.

2.
Front Public Health ; 12: 1388842, 2024.
Article in English | MEDLINE | ID: mdl-39011331

ABSTRACT

Introduction: This study was conducted on the occasion of the parricide in Bolzano (South Tyrol, Italy) in January 2021. The psychological impact of parricide on the general population and on mental health professionals has scarcely been investigated to the present day. Studies on stigmatization show differences between various groups. The aim was to analyze the emotional reactions to the parricide and the stigmatization of persons with mental disorders in the South Tyrolian population. Methods: In September 2022, 121 mental health professionals of the Department of Psychiatry in Bolzano were surveyed using an online questionnaire. In addition, from January to March 2023, the general population of South Tyrol was invited to take part in the survey through an online-link and was divided into three groups: 267 persons with mental health problems, 855 relatives and 1,019 persons with no direct or indirect contact to people with mental problems. The validated Reported and Intended Behavior Scale (RIBS) was used together with questions on the emotional reactions to the parricide and the perceived dangerousness of psychiatric patients. Descriptive statistics, one-way Anovas as well as regressions were carried out. Results and discussion: All groups experienced sadness the most. Relatives experienced more sadness and anger than the other groups. Over 80% of the professionals stated that psychiatric patients were not at greater risk of committing parricide. The population with no contact rated the risk higher than those affected and had the lowest level of openness (RIBS). There were no differences between genders, but there were age differences, with younger people being more stigmatizing. The results suggest that personal contact, appropriate information, and education are associated with less stigmatization.


Subject(s)
Emotions , Mental Disorders , Humans , Italy , Male , Female , Adult , Mental Disorders/psychology , Middle Aged , Surveys and Questionnaires , Health Personnel/psychology , Health Personnel/statistics & numerical data , Family/psychology , Stereotyping , Aged
3.
Ann Gen Psychiatry ; 23(1): 24, 2024 Jun 26.
Article in English | MEDLINE | ID: mdl-38926725

ABSTRACT

General Practitioners (GPs) play a key role in the early detection and management of depression and in preventing suicide risk. They are often the first healthcare professionals that people in crisis contact. However, their effectiveness can be limited by several barriers, including the lack of specific training and appropriate tools.The EAAD-Best project aims to fill these gaps through its iFightDepression tool, an online tool designed to support patients, psychologists, psychiatrists, and GPs in managing depression and preventing suicide. This article examines the implementation of the iFightDepression platform in Italy, assessing its impact on the empowerment of GPs in the fight against depression. Through a qualitative and quantitative analysis of the data collected by the project, the 'unmet need' of GPs' in Italy regarding their specific training in mental health is highlighted.The response of 2,068 Italian GPs in just 7 months after the start of the iFD project is an expression of GPs' engagement to work against depression and for suicide risk prevention.

4.
Behav Sci (Basel) ; 14(5)2024 May 03.
Article in English | MEDLINE | ID: mdl-38785877

ABSTRACT

The COVID-19 pandemic has led to an increase in psychological distress in the general population, but contrasting results have been shown regarding its impact on psychological symptoms in clinical and non-clinical samples. Consequently, the aim of the present study was to compare in a longitudinal design (September-November 2020 and February-April 2021) the mental health outcomes of a clinical and a control sample and to determine the implications of various risk and protective factors in this regard. A total of 234 participants from the general population and 80 psychiatric patients took part in the present online study using the following measurements: the Brief Symptom Checklist (BSCL); Three-Item Loneliness Scale (TILS); Resilience Scale-13 (RS-13); and Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale-Non-Illness (FACIT-Sp Non-Illness). The results show an overall decrease in active suicidal ideation as well as "peace", a subscale of spiritual well-being, as well as increases in passive suicidal activation in the clinical sample, which did not change in the control sample. Psychological symptoms did not significantly change in either group. Significant group effects show an increase in resilience in the clinical sample. Resilience and peace turned out to be protective factors for negative mental health outcomes. However, loneliness, which interestingly increased only in the control sample, was shown to be an overall potential risk factor. Our results highlight the complex implications of the COVID-19 pandemic on the mental health outcomes of different groups in the population, demonstrating the necessity of further research, specifically regarding the risk of active and passive suicidal activation. Highlighted protective factors are discussed in regards to spirituality (i.e., peace), which is not strictly related to religion but rather personal spirituality related to the meaning of situations of one's life, as well as in terms of mental health interventions.

5.
Front Psychiatry ; 15: 1304491, 2024.
Article in English | MEDLINE | ID: mdl-38426004

ABSTRACT

Background: Over the past years, the COVID-19 pandemic has caused significant disruptions in daily routines. Although the pandemic has affected almost everyone, it has been particularly challenging for people with pre-existing mental health conditions. Therefore, this study investigated the long-term impact of resilience and extraversion on psychological distress in individuals diagnosed with mental health disorders (MHD) compared to the general population. In addition, possible gender-specific differences were investigated. Methods: 123 patients with pre-existing MHD and 343 control subjects from Austria and Italy participated in three online surveys that had been conducted after the initial wave of the COVID-19 pandemic (t0), during the second lockdown in both countries (t1), and one year thereafter (t2). Participants completed standardized questionnaires on psychological distress (Brief-Symptom-Checklist), resilience (Resilience Scale), and extraversion (Big Five Inventory). A mediation model was employed to test the primary hypothesis. Possible gender-specific differences were analyzed using a moderated mediation model. Results: The prevalence of psychological distress was consistently higher in patients compared to controls (t0: 37.3% vs. 13.2%, t1: 38.2% vs 11.7%, t2: 37.4% vs. 13.1%). This between-group difference in psychological distress at the first follow-up was fully mediated by baseline resilience scores (65.4% of the total effect). During the second-follow up, extraversion accounted for 18% of the total effect, whereas resilience slightly decreased to 56% of the total effect. Gender was not a significant moderator in the model. Conclusion: Next to showing that people with MHD were particularly affected by the pandemic, these findings indicate that higher degrees of resilience and extraversion are related to less long-term psychological distress. Our findings stress the relevance of strengthening resilience and extraversion and to provide mental health support in times of crises, both to patients with MHD and the general population.

7.
Article in English | MEDLINE | ID: mdl-38112803

ABSTRACT

BACKGROUND: The COVID-19 pandemic and related measures have negatively impacted mental health worldwide. The main objective of the present longitudinal study was to investigate mental health in people living in Tyrol (Austria) and South Tyrol (Italy) during the COVID-19 pandemic and to report the prevalence of psychological distress among individuals with versus those without pre-existing mental health disorders (MHD) in the long-term (summer 2020-winter 2022). Here, we specifically focus on the relevance of spirituality and perceived social support in this regard. METHODS: 161 individuals who had been diagnosed with MHD and 446 reference subjects participated in this online survey. Electronic data capture was conducted using the Computer-based Health Evaluation System and included both sociodemographic and clinical aspects as well as standardized questionnaires on psychological distress, spirituality, and the perception of social support. RESULTS: The prevalence of psychological distress was significantly higher in individuals with MHD (36.6% vs. 12.3%) and remained unchanged among both groups over time. At baseline, the perception of social support was significantly higher in healthy control subjects, whereas the two groups were comparable in regards of the subjective relevance of faith. Reference subjects indicated significantly higher spiritual well-being in terms of the sense of meaning in life and peacefulness, which mediated in large part the between-group difference of psychological distress at follow-up. Notably, both faith and the perception of social support did not prove to be relevant in this context. CONCLUSIONS: These findings point to a consistently high prevalence of psychological distress among people suffering from MHD and underscore the prominent role of meaning in life and peacefulness as a protective factor in times of crisis. Therapeutic strategies that specifically target spirituality may have a beneficial impact on mental health.

8.
Ann Gen Psychiatry ; 22(1): 43, 2023 Nov 02.
Article in English | MEDLINE | ID: mdl-37919759

ABSTRACT

The digital transformation has made its way into many areas of society, including medicine. While AI-based systems are widespread in medical disciplines, their use in psychiatry is progressing more slowly. However, they promise to revolutionize psychiatric practice in terms of prevention options, diagnostics, or even therapy. Psychiatry is in the midst of this digital transformation, so the question is no longer "whether" to use technology, but "how" we can use it to achieve goals of progress or improvement. The aim of this article is to argue that this revolution brings not only new opportunities but also new ethical challenges for psychiatry, especially with regard to safety, responsibility, autonomy, or transparency. As an example, the relationship between doctor and patient in psychiatry will be addressed, in which digitization is also leading to ethically relevant changes. Ethical reflection on the use of AI systems offers the opportunity to accompany these changes carefully in order to take advantage of the benefits that this change brings. The focus should therefore always be on balancing what is technically possible with what is ethically necessary.

9.
Riv Psichiatr ; 58(5): 195-204, 2023.
Article in English | MEDLINE | ID: mdl-37807865

ABSTRACT

Falls in the elderly represent one of the major clinical problems as they are serious events that often result in high residual disability and mortality rates. Knowledge on the subject derives mainly from geriatric and gerontopsychiatric research. However, gerontopsychiatric patients differ from geriatric patients not only for the psychiatric and neurological comorbidities, which are often not sufficiently taken into account in the scientific context, but also for the intake of psychotropic drugs, notoriously described as one of the main risk factors for falls. Such drugs are widely prescribed in this group of patients, often even off-label. Clinicians therefore should pay particular attention to falls, since various comorbidities and polypharmacy as a prescribing issue can have important consequences for clinical management. Falls have not been sufficiently investigated yet in a purely psychiatric context.


Subject(s)
Accidental Falls , Psychotropic Drugs , Humans , Aged , Risk Factors , Psychotropic Drugs/adverse effects , Polypharmacy
10.
Curr Neuropharmacol ; 21(11): 2206-2216, 2023.
Article in English | MEDLINE | ID: mdl-37469149

ABSTRACT

BACKGROUND: Schizophrenia is a psychiatric disorder whose therapeutic objectives are aimed at reducing symptoms and improving patient's quality of life. First- and second-generation antipsychotics present numerous side effects. Recently introduced in the treatment of schizophrenia, cariprazine has shown to improve positive and negative symptoms as well as cognitive impairment, with good tolerability. OBJECTIVE: To assess the level of consensus among Italian psychiatrists in relation to the use of cariprazine in the treatment of schizophrenia by using the Delphi technique. METHOD: A Delphi study was undertaken between January and July 2022. Two questionnaires were consecutively sent to a panel of 97 psychiatrists from all over Italy, of which 81 actively participated, anonymously, in at least one of the two consultations with a sufficiently high response rate (83%). RESULTS: Broad consensus in terms of the efficacy and safety of cariprazine in the treatment of schizophrenia during all phases of the disorder. The young first-episode schizophrenia patient with or without substance abuse seems to be an excellent candidate for cariprazine therapy. In addition, the lack of side effects makes cariprazine a suitable drug for adult and elderly patients with schizophrenia. However, there is still limited experience with the use of cariprazine, along with little knowledge of the most recent real-life data. CONCLUSION: These results could encourage wider dissemination of evidence-based practices with the final aim of optimizing the clinical use of cariprazine in patients with schizophrenia.


Subject(s)
Antipsychotic Agents , Drug-Related Side Effects and Adverse Reactions , Schizophrenia , Adult , Humans , Aged , Schizophrenia/drug therapy , Quality of Life , Antipsychotic Agents/therapeutic use , Piperazines/adverse effects , Drug-Related Side Effects and Adverse Reactions/drug therapy
11.
Sensors (Basel) ; 23(11)2023 May 30.
Article in English | MEDLINE | ID: mdl-37299910

ABSTRACT

Prospective memory (PM) is essential in everyday life because it concerns the ability to remember to perform an intended action in the future. Individuals diagnosed with attention deficit hyperactivity disorder (ADHD) often show poor performance in PM. Because age can be confounding, we decided to test PM in ADHD patients (children and adults) and healthy controls (children and adults). We examined 22 children (four females; mean age = 8.77 ± 1.77) and 35 adults (14 females; mean age = 37.29 ± 12.23) with ADHD, in addition to 92 children (57 females; mean age = 10.13 ± 0.42) and 95 adults (57 females; mean age = 27.93 ± 14.35) as healthy controls. Each participant originally wore an actigraph around the non-dominant wrist and was requested to push the event-marker at get-up time. To assess the efficiency of PM performance, we calculated the time elapsing between the end of sleep in the morning and the pushing of the event-marker button. The results showed lower PM performance in ADHD participants, regardless of age. However, the differences between ADHD and control groups were more evident in the children group. Our data seem to confirm that PM efficiency is compromised in individuals diagnosed with ADHD regardless of age, and agree with the idea of considering the PM deficit as a neuropsychological marker of ADHD.


Subject(s)
Attention Deficit Disorder with Hyperactivity , Memory, Episodic , Adult , Child , Female , Humans , Middle Aged , Adolescent , Young Adult , Attention Deficit Disorder with Hyperactivity/diagnosis , Mental Recall , Cognition , Sleep
12.
Expert Opin Drug Metab Toxicol ; 19(4): 189-202, 2023 Apr.
Article in English | MEDLINE | ID: mdl-37259573

ABSTRACT

INTRODUCTION: Long-acting injectable (LAI) formulations of second-generation antipsychotics (SGA) are a mainstay in the treatment of schizophrenia-spectrum patients, and their use improves adherence and reduces relapse risk. Personalizing LAI-based therapy involves tailoring the transition from oral to LAIs based on individual and drug-related pharmacokinetic peculiarities. AREAS COVERED: We discuss pharmacokinetic considerations as a cornerstone of a smooth transition from oral to LAI SGAs based on works identified using an updated search in PubMed and Embase in February 2023. Establishing the extent of antipsychotic exposure during oral SGA-treatment from the patient's SGA levels is often a more appropriate orientation method to choose the equivalent LAI dose than population-based data. Oral dose adjustment during LAI transition can also be guided by checking SGA levels before the LAI injection. EXPERT OPINION: LAI SGAs may dominate the maintenance treatment of schizophrenia-spectrum disorders with increased use for other severe mental illnesses such as bipolar disorder. Spurring this trend is the development of newer formulations with longer injection intervals and increased administration ease, but transitioning from oral SGA remains a challenge. By understanding the pharmacokinetics of LAI formulations and measuring SGA levels during oral therapy, one can personalize/optimize the switch from oral SGAs to LAI counterparts.


Subject(s)
Antipsychotic Agents , Bipolar Disorder , Schizophrenia , Humans , Schizophrenia/drug therapy , Bipolar Disorder/drug therapy , Injections , Administration, Oral , Delayed-Action Preparations/therapeutic use
14.
J ECT ; 39(3): 197-201, 2023 09 01.
Article in English | MEDLINE | ID: mdl-36897195

ABSTRACT

OBJECTIVES: The prevalence and use of electroconvulsive therapy (ECT) varies widely across Europe. Historically, Switzerland played an important role in the worldwide spread of ECT. Nevertheless, an overview of current ECT practice in Switzerland is still lacking. The present study aims to fill this gap. METHODS: A cross-sectional study was conducted in 2017 using a standardized questionnaire to investigate current ECT practice in Switzerland. Fifty-one Swiss hospitals were contacted by email and followed up by telephone. In early 2022, we updated the list of facilities that offer ECT. RESULTS: Thirty eight of the 51 hospitals (74.5%) provided feedback to the questionnaire, 10 of them claimed to offer ECT. They reported 402 treated patients, which corresponds to an ECT-treated person rate of 4.8 persons per 100,000 inhabitants. Depression was the most frequent indication. All hospitals reported an increase in ECT treatments between 2014 and 2017 except for one with constant numbers. The number of facilities offering ECT almost doubled between 2010 and 2022. Most ECT facilities performed the treatment predominantly on an outpatient rather than an inpatient basis. CONCLUSIONS: Historically, Switzerland relevantly contributed to the worldwide spread of ECT. In an international comparison, the treatment frequency is in the lower middle range. The outpatient treatment rate is high compared with other countries in Europe. The supply and spread of ECT in Switzerland have increased over the past decade.


Subject(s)
Electroconvulsive Therapy , Humans , Switzerland , Health Care Surveys , Cross-Sectional Studies , Surveys and Questionnaires
15.
Brain Sci ; 13(2)2023 Jan 27.
Article in English | MEDLINE | ID: mdl-36831754

ABSTRACT

Anomalies of attentional selection have been repeatedly described in individuals with schizophrenia spectrum disorders. However, a precise analysis of their ability to inhibit irrelevant visual information during attentional selection is not documented. Recent behavioral as well as neurophysiological and computational evidence showed that attentional search among different competing stimuli elicits an area of suppression in the immediate surrounding of the attentional focus. In the present study, the strength and spatial extension of this surround suppression were tested in individuals with schizophrenia and neurotypical controls. Participants were asked to report the orientation of a visual "pop-out" target, which appeared in different positions within a peripheral array of non-target stimuli. In half of the trials, after the target appeared, a probe circle circumscribed a non-target stimulus at various target-to-probe distances; in this case, participants were asked to report the probe orientation instead. Results suggest that, as compared to neurotypical controls, individuals with schizophrenia showed stronger and spatially more extended filtering of visual information in the areas surrounding their attentional focus. This increased filtering of visual information outside the focus of attention might potentially hamper their ability to integrate different elements into coherent percepts and influence higher order behavioral, affective, and cognitive domains.

16.
Pathologica ; 115(2): 117-125, 2023 Apr.
Article in English | MEDLINE | ID: mdl-36704872

ABSTRACT

In the present article we briefly discuss the historical premises of eugenics. Differences and some analogies between the Latin and the German way of eugenics in the 20th century are presented, until the tragic antisemitic turn. The fate of some children in the South Tyrol border region is also discussed, as well as the role of several anatomo-pathologists as willing executors of autopsies on the victims of the eugenic project of eliminating mentally and physically disabled people.


Subject(s)
Eugenics , Pathologists , Child , Humans , History, 20th Century , Eugenics/history , Italy
17.
Front Psychiatry ; 13: 972141, 2022.
Article in English | MEDLINE | ID: mdl-36325531

ABSTRACT

Introduction: A titration within a certain therapeutic reference range presupposes a relationship between the blood concentration and the therapeutic effect of a drug. However, this has not been systematically investigated for escitalopram. Furthermore, the recommended reference range disagrees with mean steady state concentrations (11-21 ng/ml) that are expected under the approved dose range (10-20 mg/day). This work systematically investigated the relationships between escitalopram dose, blood levels, clinical effects, and serotonin transporter occupancy. Methods: Following our previously published methodology, relevant articles were systematically searched and reviewed for escitalopram. Results: Of 1,032 articles screened, a total of 30 studies met the eligibility criteria. The included studies investigated escitalopram blood levels in relationship to clinical effects (9 studies) or moderating factors on escitalopram metabolism (12 studies) or serotonin transporter occupancy (9 studies). Overall, the evidence for an escitalopram concentration/effect relationship is low (level C). Conclusion: Based on our findings, we propose a target range of 20-40 ng/ml for antidepressant efficacy of escitalopram. In maintenance treatment, therapeutic response is expected, when titrating patients above the lower limit. The lower concentration threshold is strongly supported by findings from neuroimaging studies. The upper limit for escitalopram's reference range rather reflects a therapeutic maximum than a tolerability threshold, since the incidence of side effects in general is low. Concentrations above 40 ng/ml should not necessarily result in dose reductions in case of good clinical efficacy and tolerability. Dose-related escitalopram concentrations in different trials were more than twice the expected concentrations from guideline reports. Systematic review registration: [https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=215873], identifier [CRD42020215873].

18.
Sci Rep ; 12(1): 19369, 2022 11 12.
Article in English | MEDLINE | ID: mdl-36371507

ABSTRACT

Recent research suggests that embodiment sensations (sense of body ownership and sense of body agency) are altered in schizophrenia. Using a mirror box illusion setup, we tested if the anomalous embodiment experience depends on deficient processing of visuomotor synchrony, disrupted processing of movement mode, or both. The task required participants to press a lever with their index while looking at the image of the experimenter's hand moving on a similar lever. The illusion of embodiment could arise because looking toward the direction of their own hand the participant saw the reflection of the experimenter's hand visually superimposed to his own one through a mirror. During the illusion induction, we systematically varied visuomotor asynchrony (4 delays were imposed on the movement of the experimenter's hand) and the mode of movement (the participant could perform active vs. passive movements). The strength of the illusion of embodiment of the external hand was assessed with explicit judgments of ownership and agency. Patients' data showed an anomalous modulation of ownership with respect to visuomotor synchrony manipulation and an altered modulation of agency with respect to both visuomotor synchrony and movement mode manipulations. Results from the present study suggest that impairments affecting both the processing of temporal aspects of visuomotor signals and the processing of type of movement underlie anomalous embodiment sensations in schizophrenia. Hypotheses about potential deficits accounting for our results are proposed.


Subject(s)
Illusions , Schizophrenia , Touch Perception , Humans , Ownership , Hand , Movement , Body Image , Proprioception , Visual Perception
19.
Psychopharmacology (Berl) ; 239(11): 3377-3391, 2022 Nov.
Article in English | MEDLINE | ID: mdl-36195732

ABSTRACT

RATIONALE: While one of the basic axioms of pharmacology postulates that there is a relationship between the concentration and effects of a drug, the value of measuring blood levels is questioned by many clinicians. This is due to the often-missing validation of therapeutic reference ranges. OBJECTIVES: Here, we present a prototypical meta-analysis of the relationships between blood levels of aripiprazole, its target engagement in the human brain, and clinical effects and side effects in patients with schizophrenia and related disorders. METHODS: The relevant literature was systematically searched and reviewed for aripiprazole oral and injectable formulations. Population-based concentration ranges were computed (N = 3,373) and pharmacokinetic influences investigated. RESULTS: Fifty-three study cohorts met the eligibility criteria. Twenty-nine studies report blood level after oral, 15 after injectable formulations, and nine were positron emission tomography studies. Conflicting evidence for a relationship between concentration, efficacy, and side effects exists (assigned level of evidence low, C; and absent, D). Population-based reference ranges are well in-line with findings from neuroimaging data and individual efficacy studies. We suggest a therapeutic reference range of 120-270 ng/ml and 180-380 ng/ml, respectively, for aripiprazole and its active moiety for the treatment of schizophrenia and related disorders. CONCLUSIONS: High interindividual variability and the influence of CYP2D6 genotypes gives a special indication for Therapeutic Drug Monitoring of oral and long-acting aripiprazole. A starting dose of 10 mg will in most patients result in effective concentrations in blood and brain. 5 mg will be sufficient for known poor metabolizers.


Subject(s)
Antipsychotic Agents , Schizophrenia , Humans , Aripiprazole/pharmacology , Aripiprazole/therapeutic use , Schizophrenia/chemically induced , Reference Values , Antipsychotic Agents/adverse effects , Cytochrome P-450 CYP2D6
20.
J Affect Disord ; 319: 646-654, 2022 12 15.
Article in English | MEDLINE | ID: mdl-36167246

ABSTRACT

Background: 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. Objectives: Evaluate the effectiveness and safety of esketamine nasal spray in a clinical sample of patients with TRD from several Italian mental health services. Methods: 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. Results: 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. Limitations: 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. Conclusions: 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.


Subject(s)
Depressive Disorder, Treatment-Resistant , Ketamine , Humans , Depression , Depressive Disorder, Treatment-Resistant/drug therapy , Ketamine/adverse effects
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