Metabolic Status Influences Probiotic Efficacy for Depression-PRO-DEMET Randomized Clinical Trial Results.

Probiotics may represent a safe and easy-to-use treatment option for depression or its metabolic comorbidities. However, it is not known whether metabolic features can influence the efficacy of probiotics treatments for depression. This trial involved a parallel-group, prospective, randomized, double-blind, controlled design. In total, 116 participants with depression received a probiotic preparation containing Lactobacillus helveticus Rosell®-52 and Bifidobacterium longum Rosell®-175 or placebo over 60 days. The psychometric data were assessed longitudinally at five time-points. Data for blood pressure, body weight, waist circumference, complete blood count, serum levels of C-reactive protein, cholesterol, triglycerides, and fasting glucose were measured at the beginning of the intervention period. There was no advantage of probiotics usage over placebo in the depression score overall (PRO vs. PLC: F(1.92) = 0.58; p = 0.45). However, we found a higher rate of minimum clinically important differences in patients supplemented with probiotics than those allocated to placebo generally (74.5 vs. 53.5%; X2(1,n = 94) = 4.53; p = 0.03; NNT = 4.03), as well as in the antidepressant-treated subgroup. Moreover, we found that the more advanced the pre-intervention metabolic abnormalities (such as overweight, excessive central adipose tissue, and liver steatosis), the lower the improvements in psychometric scores. A higher baseline stress level was correlated with better improvements. The current probiotic formulations may only be used as complementary treatments for depressive disorders. Metabolic abnormalities may require more complex treatments. ClinicalTrials.gov identifier: NCT04756544.

Evaluation of daytime sleepiness and insomnia symptoms in OSA patients with a characterization of symptom-defined phenotypes and their involvement in depression comorbidity-a cross-sectional clinical study.

Introduction: Recent research highlights the significance of insomnia and sleepiness, shifting from obstructive sleep apnea (OSA) severity and sleep structure, in defining OSA phenotypes. Objectives: This study aimed to characterize insomnia and sleepiness associated with OSA phenotypes and assess their involvement in depression symptoms (DS) in OSA. Materials and methods: This cross-sectional, clinical study included 181 participants who underwent polysomnography (PSG) and filled out questionnaires, including the Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), and Beck Depression Index (BDI). They were categorized into phenotypes: insomnia-sleepiness (I + S; ESS ≥ 11; ISI ≥ 15; n = 20), sleepiness (S; ESS ≥ 11; ISI < 15; n = 22), insomnia (I; ESS < 11; ISI ≥ 15), and asymptomatic (A; ESS < 11; ISI<15; n=55). Results: A linear regression model for the BDI score (R2 = 0.357, p < 0.001) included ISI score and subjective-to-objective sleep latency ratio. The ISI score was a predictive factor for mild and moderate DS [OR = 1.23 (95% CI: 1.09-1.38), p < 0.001 and OR = 1.39 (95% CI: 1.13-1.72), p = 0.002]. The I and I + S phenotypes are characterized by higher BDI scores (p < 0.001 and p = 0.02), longer subjective sleep latency (p = 0.008 and p = 0.04), and shorter subjective total sleep time (TST; p = 0.049 and p = 0.006) compared to A. Furthermore, the I and I + S groups had shorter subjective TST than S (p = 0.03 and p = 0.047). The I and I + S had higher BDI scores than A (p < 0.001 and p = 0.02, respectively) and S (p < 0.001 and p = 0.02, respectively). The I phenotype was associated with the risk of mild and moderate DS (OR = 5.61 (95% CI: 1.91-16.53), p < 0.001 and OR = 9.55 (95% CI: 1.81-50.48), p = 0.008 respectively). Moreover, the I + S phenotype presented an even greater risk for mild DS (OR = 10.29 (95% CI: 2.95-35.85), p < 0.001). Conclusion: Using clinical features for OSA phenotyping holds promise for finding OSA individuals with increased risk for DS occurrence.

Evaluation of COVID-19 Effect on Mental Health, Self-Harm, and Suicidal Behaviors in Children and Adolescents Population.

OBJECTIVES: The impact of the COVID-19 pandemic on the psychological state of the under-18 population includes an increased risk of psychopathological symptoms development and exacerbation of already present psychiatric disorders. This study aimed to assess the prevalence of mental health problems in Polish children and adolescents with a focus on suicidal and self-harm behavior with the impact of the pandemic. METHODS: The questionnaire collected demographic data, information regarding mental states and psychopathological symptoms, history of self-harm and suicidal behaviors, as well as the experience of psychological, and physical violence, and suicidal self-harm behaviors before and during the COVID-19 pandemic. RESULTS: In the final analysis, 782 responses were included. Self-evaluation of general and mental health scores was significantly lower during the pandemic among children (both p < 0.001) and adolescents (both p < 0.001). Moreover, general and mental health scores were lower among adolescents compared to children before (both p < 0.001) and during (both p < 0.001) the pandemic. The frequency of seeking help because of mental health problems increased during the pandemic among children and adolescents, while no changes were observed in the prevalence of psychiatric hospitalizations in either of the populations (p = 0.317 and p = 1.00, respectively). Out of autoregressive behaviors among children during the pandemic period, only the frequency of thinking about death increased (p = 0.038). No suicidal attempts were undertaken by children in either of the evaluated time periods. The presence of all autoaggressive behaviors was greater among adolescents compared to children both before and during the COVID-19 pandemic (all p<0.05). CONCLUSIONS: A subjective decrease in psychophysical well-being, an increase in the frequency of seeking mental health help during the pandemic, as well as an increased prevalence of depressive and anxiety symptoms were observed in the under-18 population as a potential consequence of the COVID-19 pandemic and related socioeconomic changes. The marked increase in self-harm behavior in the adolescent population (age > 12) and the marked increase in the frequency of death thinking in children (age ≤ 12) suggests the need for greater awareness and easier access to professional help from mental health specialists, particularly in a time of unprecedented stress and social isolation.

Evaluation of the Continuous Positive Airway Pressure Effect on Neurotrophins' Gene Expression and Protein Levels.

Neurotrophins (NT) might be associated with the pathophysiology of obstructive sleep apnea (OSA) due to concurrent intermittent hypoxia and sleep fragmentation. Such a relationship could have implications for the health and overall well-being of patients; however, the literature on this subject is sparse. This study investigated the alterations in the serum protein concentration and the mRNA expression of the brain-derived neurotrophic factor (BDNF), glial cell line-derived neurotrophic factor (GDNF), neurotrophin-3 (NTF3), and neurotrophin-4 (NTF4) proteins following a single night of continuous positive airway pressure (CPAP) therapy. This study group consisted of 30 patients with OSA. Venous blood was collected twice after a diagnostic polysomnography (PSG) and PSG with CPAP treatment. Gene expression was assessed with a quantitative real-time polymerase chain reaction. An enzyme-linked immunosorbent assay was used to determine the protein concentrations. After CPAP treatment, BDNF, proBDNF, GDNF, and NTF4 protein levels decreased (p = 0.002, p = 0.003, p = 0.047, and p = 0.009, respectively), while NTF3 increased (p = 0.001). Sleep latency was correlated with ΔPSG + CPAP/PSG gene expression for BDNF (R = 0.387, p = 0.038), NTF3 (R = 0.440, p = 0.019), and NTF4 (R = 0.424, p = 0.025). OSA severity parameters were not associated with protein levels or gene expressions. CPAP therapy could have an impact on the posttranscriptional stages of NT synthesis. The expression of different NTs appears to be connected with sleep architecture but not with OSA severity.

Shedding light on neurofilament involvement in cognitive decline in obstructive sleep apnea and its possible role as a biomarker.

Obstructive sleep apnea is one of the most common sleep disorders with a high estimated global prevalence and a large number of associated comorbidities in general as well as specific neuropsychiatric complications such as cognitive impairment. The complex pathogenesis and effects of the disorder including chronic intermittent hypoxia and sleep fragmentation may lead to enhanced neuronal damage, thereby contributing to neuropsychiatric pathologies. Obstructive sleep apnea has been described as an independent risk factor for several neurodegenerative diseases, including Alzheimer's disease and all-cause dementia. The influence of obstructive sleep apnea on cognitive deficits is still a topic of recent debate, and several mechanisms, including neurodegeneration and depression-related cognitive dysfunction, underlying this correlation are taken into consideration. The differentiation between both pathomechanisms of cognitive impairment in obstructive sleep apnea is a complex clinical issue, requiring the use of multiple and costly diagnostic methods. The studies conducted on neuroprotection biomarkers, such as brain-derived neurotrophic factors and neurofilaments, are recently gaining ground in the topic of cognition assessment in obstructive sleep apnea patients. Neurofilaments as neuron-specific cytoskeletal proteins could be useful non-invasive indicators of brain conditions and neurodegeneration, which already are observed in many neurological diseases leading to cognitive deficits. Additionally, neurofilaments play an important role as a biomarker in other sleep disorders such as insomnia. Thus, this review summarizes the current knowledge on the involvement of neurofilaments in cognitive decline and neurodegeneration in obstructive sleep apnea patients as well as discusses its possible role as a biomarker of these changes.

Sarcosine May Induce EGF Production or Inhibit the Decline in EGF Concentrations in Patients with Chronic Schizophrenia (Results of the PULSAR Study).

Sarcosine (N-methylglycine), a glutamatergic modulator, reduces the primary negative symptoms of schizophrenia. These beneficial changes might be mediated by trophic factors such as epidermal growth factor (EGF). We assessed associations between initial serum EGF levels or changes in serum EGF levels and symptom severity during the addition of sarcosine to stable antipsychotic treatment and thereby evaluated the associations between glutamatergic modulation, clinical changes and peripheral EGF concentrations. Fifty-eight subjects with a diagnosis of chronic schizophrenia with dominant negative symptoms, stably treated with antipsychotics, completed a prospective 6-month, randomized, double-blind, placebo-controlled study. Subjects received orally 2 g of sarcosine (n = 28) or placebo (n = 30) daily. Serum EGF levels and symptom severity (using the Positive and Negative Syndrome Scale (PANSS) and the Calgary Depression Scale for Schizophrenia (CDSS)) were assessed at baseline, 6-week and 6-month follow-up. Augmentation antipsychotic treatment with sarcosine had no effect on EGF serum levels at any time points. Only the sarcosine group showed a significant improvement in negative symptoms, general psychopathology subscales and the overall PANSS score. We found a reduction in serum EGF levels in the placebo group, but levels in the sarcosine remained stable during the study. Our data indicate that improvement in negative symptoms due to sarcosine augmentation is not directly mediated by EGF, but effective treatment may induce the production or block the decrease in EGF concentrations, which indicates the neuroprotective effect of treatment and confirms the relationship between neuroprotection and EGF levels.

Suicidality in the Light of Schema Therapy Constructs, i.e., Early Maladaptive Schema and Schema Modes: A Longitudinal Study.

(1) Background: The search for new strategies to diagnose people at risk of suicide and to help them is highly significant in view of the still high rate of suicidality. Schema therapy and its core constructs, i.e., early maladaptive schemas (EMSs) and schema modes, correspond to both directions. (2) Methods: This study compared the severity of EMSs and schema modes in a clinical group of suicide risk, a clinical non-suicidal group, and a control group. Intragroup comparisons were also conducted between times of crisis and psychological stability. The evaluation was supported by controlling for the psychopathological symptoms presented, following the dimensional concept. (3) Results: The unquestionable relevance of the disconnection/rejection domain in suicidality has been proven. The importance of EMSs from other domains, especially during psychiatric crises, was confirmed. Among the schema modes, child and Punitive Parent modes proved to be the most significant. There were changes in coping modes but of a lesser effect size. The protective importance of the Healthy Adult and Happy Child modes was also proven. (4) Conclusions: The results provide an indication for practitioners about the EMSs and schema modes most associated with suicide risk. They can also serve as a framework for deepening the issue of identifying and preventing suicidality in schema therapy.

Resilience and Psychological Well-Being of Polish Women in the Perinatal Period during the COVID-19 Pandemic.

PURPOSE: The COVID-19 pandemic, with its multidimensional consequences, is the most serious threat of the 21st century affecting the mental health of women in the perinatal period around the world. Resilience, which assumes the flexible use of an individual's resources in facing adversity, is an important, protective factor influencing mental well-being. The presented study aimed to determine to what extent psychological resilience, mitigates the relationship between adverse consequences of the COVID-19 pandemic and symptoms of depression and anxiety in women in the perinatal period. METHODS: We recruited pregnant women from 17 February to 13 October 2021, using social media, the parenting portal, and the snowball method. To assess mental well-being, we used: The Edinburgh Postnatal Depression Scale (EPDS), The Beck Depression Inventory (BDI-2), Self-report Labour Anxiety Questionnaire-LAQ and the self-developed COVID-19 Pandemic Anxiety Questionnaire (CRAQ). Resilience was measured usingthe Resilience Measure Questionnaire (KOP26). Multiple Correspondence Analysis (MCA), an independent t-test, and a Pearson correlation analysis were performed. RESULTS: Low resilience was significantly associated with depressive symptoms (r = -0.46; p < 0.05) and anxiety related to childbirth (r = -0.21; p < 0.05). No associations were found for resilience and pandemic-related stress. Very high and high perinatal anxiety along with the lowest level of resilience clustered with EPDS and BDI-2 scores indicating depression. CONCLUSIONS: Our study provides evidence that lower levels of resilience during pregnancy may be a significant predictor of increased severity of depressive symptoms and higher levels of anxiety related to childbirth among the perinatal population.

The Reliability and Validity of the Polish Version of the Schema Mode Inventory (SMI).

(1) Background: Schema therapy and working with schema modes is increasingly popular. Since there is no validated tool to measure schema modes in Poland, in this study, we present an assessment of the psychometric properties of the Polish version the Short Schema Mode Inventory (SMI) adaptation. (2) Methods: First, the original version of the scale was translated. Subsequently, a validity and reliability study was conducted on a sample of 240 patients and 400 non-patients. In particular, the factor structure of the inventory was checked, internal reliability and intercorrelations between subscales were tested, differences between the clinical and non-clinical groups in terms of the severity of each factor were examined, and construct validity was assessed by comparing the association of results with external variables. (3) Results: The results did not conclusively confirm the 14-factor structure postulated in the original scale. Nevertheless, the relatively best fit indices were obtained for such a model. The internal reliability for the 14 subscales ranged from 0.74 to 0.95 (McDonald's omega). Correlations between subscales demonstrated values from 0.03 to 0.72. The existence of differences between the clinical and non-clinical groups and the construct validity were confirmed. (4) Conclusions: The psychometric evaluation performed is mostly similar to the results obtained for other adaptations, and the results justify the inventory being used for research and clinical purposes when knowledge of its limitations is included.

Resilience and Strategic Emotional Intelligence as Mediators between the Disconnection and Rejection Domain and Negative Parenting among Female Intimate Partner Violence Victims.

(1) Background: The exposure of children to intimate partner violence (IPV) is associated with a wide range of negative effects on children's development, where as parenting practice is considered to be one of the key factors mediating and mitigating this. Studies have found mixed results regarding the impact of female IPV victimization on maternal parenting practice; however, the most frequently tested hypothesis suggests that the cumulative stress of the IPV experience may emotionally deregulate the mother, contributing to an increased risk of neglected and abusive parenting practices. Little is still known about the factors determining the observed differences in maternal parenting practices among IPV victims. Thus, in our study, we use mediation models to provide preliminary results exploring the role of resilience and strategic emotional intelligence in the relationship between women's disconnection and rejection (D/R) schema domain and maternal parenting practice among IPV victims. (2) Methods: A total of 48 female survivors of IPV and 48 age-matched women with no prior experience of IPV completed a set of tests examining parenting practices, the D/R domain, resilience and emotional intelligence. (3) Results: IPV victimization was associated with significantly higher rates of negative parenting practices. The D/R domain was found to be a significant predictor of parental autonomy attitude and level of parental competence, and these relationships were fully mediated by resilience with strategic emotional intelligence and resilience, respectively. (4) Conclusions: The results shed light on the under-researched relationship between early maladaptive schemas and parenting behavior in the context of IPV. The implications for clinical practice and further research can be drawn based on the study findings.

Ghrelin as a Biomarker of "Immunometabolic Depression" and Its Connection with Dysbiosis.

Ghrelin, a gastrointestinal peptide, is an endogenous ligand of growth hormone secretagogue receptor 1a (GHSR1a), which is mainly produced by X/A-like cells in the intestinal mucosa. Beyond its initial description as a growth hormone (GH) secretagogue stimulator of appetite, ghrelin has been revealed to have a wide range of physiological effects, for example, the modulation of inflammation; the improvement of cardiac performance; the modulation of stress, anxiety, taste sensation, and reward-seeking behavior; and the regulation of glucose metabolism and thermogenesis. Ghrelin secretion is altered in depressive disorders and metabolic syndrome, which frequently co-occur, but it is still unknown how these modifications relate to the physiopathology of these disorders. This review highlights the increasing amount of research establishing the close relationship between ghrelin, nutrition, microbiota, and disorders such as depression and metabolic syndrome, and it evaluates the ghrelinergic system as a potential target for the development of effective pharmacotherapies.

Borderline personality - from psychoanalysis to epigenetics. Biological basis of attachment. / Osobowosc borderline ­ od psychoanalizy do epigenetyki. Biologiczne podloze wiezi.

In terms of object relations theory, borderline personality disorder (BPD) is characterized by a structural abnormality of identity, conflicting representations of self and others, and disorganization of attachment - a construct rooted in an individual's early experiences and central to the relationships established later in life. A special role in the formation of attachment style is attributed to the relationship with the caregiver and to difficult experiences or traumas from early developmental stages. These experiences not only provide the psychological basis for the development of an insecure attachment style, but also leave a biological mark in the body in the form of epigenetic modifications. Although research on epigenetic modifications in BPD is scarce, a growing body of evidence supports the importance of oxytocin - the "social peptide" underlying attachment - in the etiology of BPD. We believe that the study of epigenetic modifications that affect the action of oxytocin in the BPD clinical population will provide a better understanding of the basis and process of development of the disorder, as well as provide a therapeutic direction to work effectively in the major areas of BPD.

Early Maladaptive Schemas and Schema Modes among People with Histories of Suicidality and the Possibility of a Universal Pattern: A Systematic Review.

BACKGROUND: The identification of variables affecting suicidality and the search for interventions to reduce suicide risk are priorities among mental health researchers. A promising direction for such research is schema therapy and its two main constructs, i.e., early maladaptive schemas (EMSs) and schema modes. METHODS: This systematic review was designed in accordance with the PRISMA guidelines. It summarizes the studies conducted to date that describe the relationship between EMSs and schema modes and measures of suicidality in individuals over the age of 16. RESULTS: The review confirmed that there are many significant associations between EMSs (especially from the Disconnection/Rejection domain) and suicide risk. Although only one study was found that explores the association between schema modes and suicidality, the correlations it identified are also confirmed here. DISCUSSION: The results show the unquestionable importance of EMSs and schema modes in assessing suicide risk. The co-occurrence of these variables represents the first step in further assessing causality and introducing schema therapy techniques into work with patients who are at risk of suicide. This issue requires more extensive experimental research.

Molecular Mechanisms Underlying NMDARs Dysfunction and Their Role in ADHD Pathogenesis.

Attention deficit hyperactivity disorder (ADHD) is one of the most common neurodevelopmental disorders, although the aetiology of ADHD is not yet understood. One proposed theory for developing ADHD is N-methyl-D-aspartate receptors (NMDARs) dysfunction. NMDARs are involved in regulating synaptic plasticity and memory function in the brain. Abnormal expression or polymorphism of some genes associated with ADHD results in NMDAR dysfunction. Correspondingly, NMDAR malfunction in animal models results in ADHD-like symptoms, such as impulsivity and hyperactivity. Currently, there are no drugs for ADHD that specifically target NMDARs. However, NMDAR-stabilizing drugs have shown promise in improving ADHD symptoms with fewer side effects than the currently most widely used psychostimulant in ADHD treatment, methylphenidate. In this review, we outline the molecular and genetic basis of NMDAR malfunction and how it affects the course of ADHD. We also present new therapeutic options related to treating ADHD by targeting NMDAR.

The role of microRNAs in pathophysiology and diagnostics of metabolic complications in obstructive sleep apnea patients.

Obstructive sleep apnea (OSA) is one of the most common sleep disorders, which is characterized by recurrent apneas and/or hypopneas occurring during sleep due to upper airway obstruction. Among a variety of health consequences, OSA patients are particularly susceptible to developing metabolic complications, such as metabolic syndrome and diabetes mellitus type 2. MicroRNAs (miRNAs) as epigenetic modulators are promising particles in both understanding the pathophysiology of OSA and the prediction of OSA complications. This review describes the role of miRNAs in the development of OSA-associated metabolic complications. Moreover, it summarizes the usefulness of miRNAs as biomarkers in predicting the aforementioned OSA complications.

Cognitive-Affective Risk Factors of Female Intimate Partner Violence Victimization: The Role of Early Maladaptive Schemas and Strategic Emotional Intelligence.

(1) Background: Intimate partner violence (IPV) is a pervasive and destructive phenomenon. There is a need for an integrated and comprehensive approach to IPV in order to align prevention, support and treatment. Still little is known about the cognitive and affective markers of IPV that are modifiable. Such knowledge, therefore, can support the effectiveness of prevention and intervention programs. In this study, we put forward a hypothesis that, after accounting for the influence of sociodemographic variables, the domains of early maladaptive schemas (EMS) and strategic emotional intelligence would provide additional information for predicting female IPV victimization. (2) Methods: 48 female survivors of IPV and 48 age-matched women with no prior experience of IPV completed the Young Schema Questionnaire-Short Form 3 (YSQ-SF3) and The Emotional Understanding Test (TRE). (3) Results: The domains of disconnection and rejection and impaired limits were significant predictors of IPV victimization, but the results did not support the predictive value for impaired autonomy, other-directedness and strategic emotional intelligence. (4) Conclusions: Our findings add to the emerging evidence of a link between disconnection and rejection domain and IPV victimization. As a consequence, maladaptive beliefs that interpersonal relationships are unstable and insecure and expose to the risk of humiliation and harm, and that basic emotional needs cannot be satisfied in close relationships, are associated with a higher risk of intimate partner violence. In this context, schema therapy appears to be a promising support for IPV victims.

Influence of glutamatergic and GABAergic neurotransmission on obstructive sleep apnea.

Glutamate and γ-aminobutyric acid (GABA) are the two main neurotransmitters in the human brain. The balance between their excitatory and inhibitory functions is crucial for maintaining the brain's physiological functions. Disturbance of glutamatergic or GABAergic neurotransmission leads to serious health problems including neurodegeneration, affective and sleep disorders. Both GABA and glutamate are involved in the control of the sleep-wake cycle. The disturbances in their function may cause sleep and sleep-related disorders. Obstructive sleep apnea (OSA) is the most common sleep respiratory disorder and is characterized by repetitive collapse of the upper airway resulting in intermittent hypoxia and sleep fragmentation. The complex pathophysiology of OSA is the basis of the development of numerous comorbid diseases. There is emerging evidence that GABA and glutamate disturbances may be involved in the pathogenesis of OSA, as well as its comorbidities. Additionally, the GABA/glutamate targeted pharmacotherapy may also influence the course of OSA, which is important in the implementation of wildly used drugs including benzodiazepines, anesthetics, and gabapentinoids. In this review, we summarize current knowledge on the influence of disturbances in glutamatergic and GABAergic neurotransmission on obstructive sleep apnea.

Deep Brain Stimulation in the Treatment of Tardive Dyskinesia.

Tardive dyskinesia (TD) is a phenomenon observed following the predominantly long-term use of dopamine receptor blockers (antipsychotics) widely used in psychiatry. TD is a group of involuntary, irregular hyperkinetic movements, mainly in the muscles of the face, eyelid, lips, tongue, and cheeks, and less frequently in the limbs, neck, pelvis, and trunk. In some patients, TD takes on an extremely severe form, massively disrupting functioning and, moreover, causing stigmatization and suffering. Deep brain stimulation (DBS), a method used, among others, in Parkinson's disease, is also an effective treatment for TD and often becomes a method of last resort, especially in severe, drug-resistant forms. The group of TD patients who have undergone DBS is still very limited. The procedure is relatively new in TD, so the available reliable clinical studies are few and consist mainly of case reports. Unilateral and bilateral stimulation of two sites has proven efficacy in TD treatment. Most authors describe stimulation of the globus pallidus internus (GPi); less frequent descriptions involve the subthalamic nucleus (STN). In the present paper, we provide up-to-date information on the stimulation of both mentioned brain areas. We also compare the efficacy of the two methods by comparing the two available studies that included the largest groups of patients. Although GPi stimulation is more frequently described in literature, our analysis indicates comparable results (reduction of involuntary movements) with STN DBS.

PRO-DEMET Randomized Controlled Trial on Probiotics in Depression-Pilot Study Results.

There is a pressing need to identify new treatment options for depression and its comorbidities. Depression often coexists with metabolic complications, and the two may share a pathophysiological overlap, including inflammation and microbiota changes. Microbiota interventions (e.g., probiotics) may represent a safe and easy-to-use treatment option as an adjunctive therapy in patients only partially responsive to pharmacologic treatment. (1) Objective: The paper presents the results of a feasibility and pilot study. The study is an internal part of a randomized controlled trail (RCT) of the effect of probiotic supplementation on psychometric, anthropometric, metabolic, and inflammatory parameters in adult patients with depressive disorders depending on the presence of metabolic syndrome. (2) Methods: The trial has a four-arm, parallel-group, prospective, randomized, double-blind, controlled design. Sixty participants received a probiotic preparation containing Lactobacillus helveticus Rosell®-52 and Bifidobacterium longum Rosell®-175 over 60 days. The feasibility of the study design was assessed, as well as the rates of recruitment, eligibility, consent, and study completion. The following were assessed: depressive, anxiety and stress symptoms, quality of life, blood pressure, body mass index and waist circumference, complete blood count with differential, serum levels of C-reactive protein, high-density lipoprotein cholesterol, triglycerides, fasting glucose, some secondary markers of inflammation and metabolic health, as well as noninvasive biomarkers of liver fibrosis (APRI and FIB-4). (3) Results: The study was found to be generally feasible. The eligibility rate was 52% of recruited participants with 80% completing the study protocol. No differences in sociodemographic or anthropometric factors or basic laboratory findings were found between the placebo and probiotic group at the start of the intervention period. Importantly, the proportion of recruited participants fulfilling the criteria of metabolic syndrome was too low. (4) Conclusions: Whilst the whole study protocol was feasible, some different timepoint procedures require modification. The major weakness of the recruitment methods was that the percentage of metabolic arms participants was insufficient. Overall, the full RCT design on probiotics in depression with vs. without metabolic syndrome was shown to be feasible with little modification.