Search Results (215)

Background: Alterations in peripheral red blood cell (RBC) indices have been proposed as potential biomarkers for Parkinson’s disease (PD), but their diagnostic utility and relation to clinical features remain uncertain. Methods: We conducted a pilot case–control study involving 70 PD patients and 122 controls from two neurology centers in Mexico. Standardized hematology analyses provided RBC indices, and neuropsychiatric assessments included the Hamilton Depression Rating Scale (HAM-D) and Mini-Mental State Examination (MMSE). Associations between RBC indices and PD were tested using multivariable logistic regression adjusted for age, sex, and smoking. Diagnostic performance was evaluated by receiver operating characteristic (ROC) curve analysis. Subgroup analyses stratified PD patients by age at onset, disease duration, and Hoehn and Yahr (HY) stage. Results: PD patients exhibited significantly higher mean corpuscular hemoglobin (MCH) and mean corpuscular hemoglobin concentration (MCHC) than controls. Elevated MCHC was independently associated with PD (OR = 1.68, 95% CI 1.35–2.09; p < 0.001). Sex-stratified models confirmed consistent associations in women (OR = 1.57) and men (OR = 1.79). ROC analysis demonstrated fair diagnostic accuracy for MCHC (AUC 0.72, 95% CI 0.65–0.80; cutoff 33.9 g/dL, sensitivity 62.9%, specificity 72.1%). Sex-specific thresholds improved sensitivity in women (90.6%) and specificity in men (74.6%). Within the PD group, MCHC did not differ by HY stage or disease duration, and showed no correlation with UPDRS, HAM-D, or MMSE scores. Early-onset cases (<50 years) showed numerically higher MCHC, though numbers were limited. Conclusions: This pilot study confirms that an elevated MCHC is independently associated with PD, a finding consistent across both sexes and independent of disease severity. MCHC demonstrates fair diagnostic performance, supporting its potential as a low-cost, accessible biomarker. Larger longitudinal studies integrating RBC indices with inflammatory and iron-regulatory markers are warranted to establish their role in the diagnosis and differential diagnosis of PD. Elevated MCHC was associated with PD, and an MCHC-based index (cutoff 33.9 g/dL; AUC 0.72, sensitivity 62.9%, specificity 72.1%) showed potential as a simple diagnostic marker. Full article

Background/Objectives: Recent evidence suggests that gut microbiota plays an important role in anxiety and stress-related disorders through interactions along the gut–brain axis. Our aim was to determine the microbiological diversity of intestinal microorganisms in individuals with acute and remission phases of PD when compared to healthy individuals. Another aim was also to analyze the differences in the metabolic pathways occurring in the intestinal microbiota of individuals from the three analyzed groups. Methods: A diagnosis was established using the Mini-International Neuropsychiatric Interview (M.I.N.I). The gut’s microbiota composition was analyzed through bacterial 16S rRNA gene sequencing (V1–V2 regions). The clinical evaluations included a BMI measurement, Short Form-36 Health Survey (SF-36), Hamilton Anxiety Scale (HAM-A), Montgomery–Åsberg Depression Rating Scale (MADRS), Columbia-Suicide Severity Rating Scale (C-SSRS), and State-Trait Anxiety Inventory (STAI). Results: We recruited 62 participants (31 PD and 31 controls). After conducting quality control filtering, data from 54 participants were analyzed (25 PD, 11 acute, 14 remission, and 29 controls). Observed richness was lower in the acute PD (63) group than in the control (74) and remission (66) (p = 0.038) groups, whereas the Shannon and Simpson indices and beta diversity (PERMANOVA) were not significantly different. The Ruminococcus gnavus group was enriched in acute PD; no other deconfounded differences in microbial composition were detected. Predicted functional differences were detected by edgeR only and included the pathways that are related to steroid biosynthesis and innate immune signaling. Conclusions: Distinct gut microbial signatures were associated with PD, implicating both the metabolic and inflammatory pathways in disease pathophysiology. Full article

Background and Objectives: Anhedonia, a core symptom of major depressive disorder (MDD), is a known predictor of treatment response. It has been linked to heart rate variability (HRV), a physiological marker implicated in both MDD and cardiovascular disease. Agomelatine, a melatonergic antidepressant, has shown positive effects on both anhedonia and HRV. But little is known about the relationship between anhedonia improvement and HRV changes. This study aimed to investigate whether early changes in HRV predict anhedonia improvement following 8 weeks of agomelatine monotherapy. Materials and Methods: We enrolled 84 unmedicated patients with MDD and 143 age- and sex-matched healthy controls (HCs). Resting-state HRV, indexed by the standard deviation of NN intervals (SDNN), was recorded at baseline for all participants and after 1, 4, and 8 weeks of agomelatine treatment in patients. Anhedonia was assessed using the Snaith–Hamilton Pleasure Scale (SHAPS). Results: At baseline, patients exhibited significantly lower SDNN than HCs. After 8 weeks, SDNN levels in patients no longer differed significantly from HCs. SDNN decreased after one week of treatment but increased by week eight. Notably, a smaller reduction in SDNN after one week predicted greater improvement in anhedonia at week eight, filling the gap in the literature needed to facilitate treatment outcome prediction by integrating HRV assessment. Conclusions: Here we demonstrate that early reductions in HRV may serve as a predictive biomarker for anhedonia response to agomelatine in MDD. These findings support the potential utility of HRV monitoring to guide personalized treatment strategies. Full article

Background/Objectives: Burning Mouth Syndrome (BMS) is a chronic orofacial pain disorder characterized by persistent intraoral burning sensations without visible mucosal lesions. Although its biopsychosocial complexity is increasingly recognized, cross-cultural comparison data remain limited. Methods: This cross-sectional study assessed 60 patients with BMS (30 Italian, 30 Romanian) who underwent standardized clinical, psychological, and sleep evaluations. Data collected included sociodemographics, clinical characteristics, diagnostic history, comorbidities, and symptomatology. The assessment tools used included the Numeric Rating Scale (NRS), Short Form of the McGill Pain Questionnaire (SF-MPQ), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D), Pittsburgh Sleep Quality Index (PSQI), and Epworth Sleepiness Scale (ESS). Statistical comparisons were conducted using Mann–Whitney U and Fisher’s exact tests with Bonferroni correction. Results: No significant differences were observed in age, sex, or body mass index. Italian patients had fewer years of education (p = 0.001), higher pain intensity (NRS, p < 0.001), poorer sleep quality (PSQI, ESS, p = 0.001), and more frequent pre-existing sleep disorders (p < 0.001). Romanian patients showed higher levels of anxiety (HAM-A, p < 0.001), longer diagnostic delays (p = 0.002), and more dysesthetic or perceptual symptoms, including tingling and oral dysmorphism (p < 0.05). Stressful events before onset were more common among Romanians (p < 0.001), while Italians more often received a correct diagnosis at first consultation (p = 0.005). Conclusions: This first cross-national comparison of BMS in Western and Eastern Europe shows that cultural, healthcare, and clinician education differences can shape symptom profiles, comorbidities, and diagnostic delays, underscoring the need for personalized, country-specific management strategies. Full article

Background and Objectives: Multiple sclerosis (MS) is a chronic immune-mediated neurological disorder that primarily affects young adults and is frequently accompanied by psychiatric comorbidities such as depression and anxiety, both of which significantly diminish patients’ quality of life (QoL). This study investigated the effect of two oral disease-modifying therapies (DMTs), fingolimod and cladribine, on mental health and QoL in patients with relapsing-remitting MS (RRMS). The aim of the study was to compare levels of depression, anxiety, and health-related quality of life (HRQoL) in RRMS patients treated with fingolimod or cladribine, and to evaluate their associations with clinical and radiological parameters. Materials and Methods: Eighty RRMS patients aged 18 to 50 years with Expanded Disability Status Scale (EDSS) scores of 3.0 or less, no recent disease relapse, and no history of antidepressant use were enrolled. Forty patients were treated with fingolimod and forty with cladribine. Depression and anxiety were assessed using the Hamilton Depression Rating Scale (HDRS) and the Hamilton Anxiety Rating Scale (HARS). QoL was evaluated using the Multiple Sclerosis QoL-54 (MSQOL-54) instrument. Additional clinical data, including MRI-based lesion burden, EDSS scores, age, disease duration, and occupational status, were collected. Results: No statistically significant differences were observed between the two groups regarding HDRS and HARS scores (p > 0.05). However, patients treated with fingolimod had significantly higher scores in the Energy/Fatigue subdomain (7.55 ± 2.02 vs. 6.56 ± 2.57, p = 0.046) and Composite Mental Health (CMH) score (64.73 ± 15.01 vs. 56.00 ± 18.93, p = 0.029) compared to those treated with cladribine. No significant differences were found in the independent items of the MSQOL-54. A negative correlation was identified between total lesion load and QoL scores. Conclusions: Although fingolimod and cladribine exert comparable effects on depression and anxiety levels, fingolimod may be associated with better mental health outcomes and reduced fatigue in RRMS patients. Furthermore, lesion burden and clinical parameters such as age and EDSS score may independently influence QoL, regardless of the DMT used. Full article

Introduction: The introduction of the transdiagnostic approach in psychiatry shifts the focus from discrete diagnoses to shared symptoms across various disorders. The Transdiagnostic Global Impression—Psychopathology (TGI-P) scale is a newly developed tool designed to assess psychiatric symptoms across diagnostic boundaries. It evaluates ten core symptom domains—positive, negative, cognitive, manic, depressive, addiction, anxiety, sleep, hostility, and self-harm—regardless of specific diagnoses. Objective: This study aims to evaluate the efficacy of cariprazine across these ten transdiagnostic symptom domains. Methods: A systematic literature review and meta-analysis were conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Searches were performed on EMBASE and clinicaltrials.gov. Efficacy measures such as the Positive and Negative Syndrome Scale (PANSS), Montgomery–Åsberg Depression Rating Scale (MADRS), Young Mania Rating Scale (YMRS), Hamilton Anxiety Rating Scale (HAM-A), and Columbia-Suicide Severity Rating Scale (C-SSRS) were used to assess cariprazine’s effect on the ten transdiagnostic symptoms. Multilevel random-effects meta-analyses were conducted to evaluate the efficacy of cariprazine versus placebo in alleviating depressive and anxiety symptoms across clinical trials. Results: A total of 30 studies were included in the review. Cariprazine showed therapeutic benefits on positive, negative, manic, and depressive symptoms in specifically designed trials. Preliminary positive effects were seen on anxiety, hostility, and cognitive symptoms across disorders. However, specific trials have not been conducted for anxiety disorders or cognitive impairment. Meta-analyses demonstrated that cariprazine significantly reduces both depressive and anxiety symptoms compared to placebo. Cariprazine significantly improved sleep-related symptoms in both mania and depression trials. Suicidality was evaluated in non-suicidal populations, and no increase was observed. Addiction symptoms were part of the exclusion criteria in the RCTs, so they could not be assessed. Previous reports of cariprazine’s anti-craving and anti-abuse effects come from real-world evidence rather than RCT data. Conclusions: Cariprazine appears to be promising in addressing a broad range of symptom domains across psychiatric conditions. Full article

Major Depressive Disorder (MDD) is a chronic mental disorder characterized by anhedonia, loss of desire, guilt, suicidal thoughts, and appetite changes. It is reported that individuals with MDD resort to binge eating to escape from negative feelings. In this study, we aimed to determine the relationship between binge eating behavior and the concept of psychological pain associated with emotions such as shame, guilt, and anger in individuals with MDD. We conducted the study in the Psychiatry Outpatient Clinics of Balcalı Hospital, Çukurova University Faculty of Medicine. The sample consisted of 147 individuals with MDD without psychotic symptoms and 128 healthy controls with sociodemographic characteristics similar to the MDD group. We administered a sociodemographic data form, the Hamilton Depression Rating Scale (HDRS), Psychache Scale (PS), Tolerance for Mental Pain Scale-10 (TMPS-10), Barratt Impulsiveness Scale (BIS-11), and Eating Disorder Examination Questionnaire (EDE-Q-13). Eighty-two (55.7%) of the patients with MDD were diagnosed with binge eating disorder (BED). In the group of MDD patients with BED comorbidity, the EDE-Q-13 total, binging subscale, and HDRS scores were significantly higher than those of the other groups (p < 0.05 for each group), with large to very large effect sizes (e.g., EDE-Q-13 binging d = 1.04; HDRS d = 1.91; PS d = 1.22). There was no significant difference between the MDD groups (with and without BED) regarding the BIS and BIS subscales’ subscores, PS, and TMPS scores. For participants with MDD, there was a significant same-directional correlation between EDE-Q-13 binging, HDRS, BIS, and PS scores (p < 0.05 for each), with moderate to strong effect sizes (EDE-Q-13 binging and HDRS: r = 0.398, p < 0.001; binging and PS: r = 0.273, p < 0.001; binging and BIS: r = 0.233, p = 0.005; binging and TMPS-10: r = –0.257, p = 0.002). Additionally, a negative correlation was observed between TMPS and the scores for EDE-Q-13 binging, HDRS, BIS, and PS. A linear regression analysis indicated that depression severity and BMI were the strongest predictors of binge eating behavior (R² = 0.243; f² = 0.32). Based on our results, we concluded that the presence of binge eating behavior in patients with MDD is associated with more severe depressive symptoms, psychological pain, impulsivity, and lower tolerance to psychological pain. The finding that binge eating behavior was most strongly associated with depression severity and body mass index (BMI) supports the notion that binge eating behavior is a maladaptive attitude. Longitudinal studies comparing individuals with different BMIs in different clinical samples are needed to confirm our results. Full article

Background: Adipokines secreted by the adipose tissue and placenta play a critical role in regulating metabolic functions that are essential for fetoplacental development and embryonic growth. While adipokines are known to impact a wide range of physiological and pathological conditions, their role in affective disorders during pregnancy remains underexplored. In this study, we aimed to assess the serum levels of distinct adipokines and examine their association with anxiety and comorbid depression in pregnant women. Methods: Third-trimester pregnant women with severe anxiety (ANX, n = 45) and anxiety plus depressive symptoms (ANX + DEP, n = 61) were enrolled in the study, along with healthy control subjects (CTRL, n = 33). Participants were classified using the Hamilton Anxiety Rating Scale (HARS) and the Hamilton Depression Rating Scale (HDRS). Serum levels of adiponectin, adipsin, leptin, and resistin were quantified by flow cytometry-based immunoassay. Clinical, biochemical, and demographic parameters were analyzed using ANOVA with a post hoc Tukey test. Pearson bivariate and partial correlations were performed to assess associations between variables. Results: Adipokine serum levels were significantly higher in the symptomatic groups (ANX, ANX + DEP) than in the CTRL group (p < 0.001). Adiponectin, leptin, and resistin levels positively correlated with anxiety symptoms (HARS, p < 0.01). Furthermore, resistin levels showed a strong association with depressive symptoms (HDRS, p = 0.001) in the ANX + DEP group, after adjusting all parameters by clinical confounders. Conclusions: Our findings revealed that both pro- and anti-inflammatory adipokine levels are elevated in women with affective symptoms during late pregnancy. Pro-inflammatory properties of leptin and resistin may contribute to the severity of anxiety symptoms. Notably, resistin emerges as a key adipokine associated with the expression of depressive symptoms. In addition, adiponectin, acting as an anti-inflammatory mediator, may counteract the inflammatory responses induced by leptin and resistin. These results provide new insights into the role of specific adipocytokine in women with affective disorders during late pregnancy. Full article

Background: Depression and anxiety are common in patients with chronic respiratory diseases (CRDs), but their prevalence in intensive care settings, particularly in low-resource regions, remains underexplored. Objective: To assess the prevalence and severity of depression and anxiety in patients with CRDs admitted to an intensive care unit (ICU) and identify associated factors. Methods: A cross-sectional study was conducted at Gulab Devi Teaching Hospital, Lahore, Pakistan. Adult patients with CRDs admitted to the ICU were assessed using the Hamilton Depression Rating Scale. Statistical analyses included Fisher’s exact test, Mann–Whitney/Kruskal–Wallis tests, and logistic regression. Results: Depression was highly prevalent across all CRD categories: 83%, 89%, 84%, and 93% in obstructive, restrictive, infectious, and other respiratory disease categories, and severe depression in 16%, 18%, 14%, and 37%, respectively. Anxiety symptoms were also widespread (77–100%), with no significant differences across disease groups. Depression was significantly associated with older age (p < 0.001, OR 1.08) and anxiety symptoms (p < 0.001, OR 47.07). Female gender was linked to anxiety (p = 0.034, OR 4.17). Conclusion: The high burden of depression and anxiety in ICU patients with CRDs underscores the need for routine psychiatric screening and integrated mental health care in critical-care settings. Full article

Background and Objectives: Major depressive disorder (MDD) is a prevalent psychiatric illness increasingly recognized as a systemic condition with implications for cardiovascular diseases. Growing evidence indicates that individuals with MDD have an elevated risk of cardiovascular mortality, underscoring the need for reliable, non-invasive biomarkers to assess cardiac risk. While underlying mechanisms remain unclear, electrocardiogram (ECG)-based markers offer a promising, non-invasive means of evaluation. Among these, the electrical risk score (ERS), a composite derived from specific ECG parameters, has emerged as a predictor of adverse cardiac outcomes. This study aimed to investigate the association between ERS and MDD, and whether ERS correlates with depression severity and illness duration. Materials and Methods: In this retrospective cross-sectional study, 12-lead ECGs were evaluated to calculate the ERS based on six ECG parameters: heart rate, corrected QT interval, Tp-e interval, frontal QRS-T angle, QRS transition zone, and presence of left ventricular hypertrophy according to Sokolow–Lyon criteria. The Hamilton Depression Rating Scale (HAM-D) was utilized. Results: The study included 102 patients with MDD and 62 healthy controls. No significant differences were observed in baseline or laboratory parameters between the groups. However, heart rate, Tp-e interval, frontal QRS-T angle, and ERS were significantly higher in the depression group. ROC analysis identified ERS as the strongest predictor of depression. ERS was significantly higher in patients with severe depression compared to those with mild symptoms and showed a positive correlation with both disease duration and HAM-D score. Conclusions: Here, we show that the ECG-derived ERS is significantly elevated in patients with MDD and is associated with increased cardiac risk. ERS outperformed conventional ECG parameters in identifying individuals with depression and demonstrated positive associations with both illness duration and symptom severity. These findings suggest that ERS may serve as a practical, non-invasive biomarker for assessing cardiovascular vulnerability in this population. Full article

Objective: Current interventions for anxiety, depression, and insomnia are efficacious, yet effectiveness may be limited by side effects and/or high withdrawal rates. Other desirable treatment options are needed. Many veterans and civilians are turning to acupuncture as an emerging therapy. Our objective was to conduct a more definitive study comparing verum with sham acupuncture (minimal needling). Methods: A two-arm, single-blinded randomized controlled trial (RCT) hypothesizing that both verum and sham acupuncture are effective and the effects of verum are superior to those of sham acupuncture. We recruited subjects from a single outpatient-based site, the Tibor Rubin VA Medical Center, Long Beach, CA, USA. A total of 93 treatment-seeking combat Veterans with posttraumatic stress disorder (PTSD), aged 18–55, were allocated to groups by adaptive randomization, and 71 participants completed the intervention protocols. Verum and sham were both offered as 1 h sessions, twice a week, and participants were allowed 15-weeks to complete up to 24 sessions. This was a secondary analysis from a larger study about the efficacy of acupuncture for PTSD. Outcomes for the current study were pre- to post-intervention change in the Hamilton Anxiety Rating Scale, Beck Depression Inventory, and Pittsburgh Sleep Quality Index. Outcomes were assessed pre-, mid-, and post-treatment. General Linear Models comparing within- and between-group results were analyzed in both intention-to-treat (ITT) and treatment completer models. Results: In total, 85 males and 8 females, with a mean age of 39.2 (median = 37.0), were randomized. For anxiety, the verum acupuncture showed a large treatment effect (d = 1.3), whereas sham acupuncture showed a moderate effect (d = 0.9). There was no statistical difference between the verum and sham acupuncture groups. Similar effects were found for depression and insomnia symptoms. Withdrawal rates were low. Conclusions: Both verum and sham acupuncture were efficacious in the treatment of anxiety, depression, and insomnia in a population of veterans with PTSD. However, there was no clinical difference between the verum and sham acupuncture groups. These data build on extant literature and suggest that further research on the clinical implementation and durability of acupuncture for anxiety, depression, and insomnia is warranted. Full article

Background: Youth (ages 16–25) is a key window for mental health interventions, as depression rates significantly increase during this developmental stage. However, transcranial direct current stimulation (tDCS) application in youth depression remains underexplored. To reduce the uncertainty of a future trial, we conducted a review and a pilot randomised controlled trial (RCT) of tDCS for youth depression. Methods: Following the PRISMA guidelines, the first part of this study was a review across databases including PubMed, MEDLINE, PsychInfo, CINAHL, Open Access Theses and Dissertations (OATD), WanFang Data, Chinese Medical Journal, and clinical trial registries up to 20 November 2024, on tDCS treatment for youth depression. The second part of this study was a double-blind pilot RCT assessing feasibility, by comparing active tDCS (five daily 30 min 2 mA anodal tDCS applications over the left dorsolateral–pre-frontal-cortex (DLPFC) with sham tDCS. Feasibility outcomes included recruitment, data collection, attendance, retention and randomisation. Outcomes also included depression severity using the Hamilton Depression Rating Scale (HDRS), safety, tolerability, acceptability, and adequacy of blinding. Mann–Whitney U tests were used for between-group comparison. Results: Fourteen eligible studies were identified, with a pooled HDRS reduction of −9.6 (95% CI: −11.2 to −8.1, p < 0.001), though high risks of bias indicated a research gap. Using parameters derived from the review, we conducted a pilot RCT in which 20 youths were screened and 8 were randomised (aged 16–24; 3 females, 5 males). All randomised participants completed their assigned sessions without dropout or protocol discontinuations. Blinding was adequate, and participants’ willingness to engage improved over time. Both groups showed reductions in HDRS, with a greater mean reduction in the active group (−4.75 ± 2.96) compared to the sham group (−3.75 ± 3.78). No serious adverse events occurred, with only mild headaches and tingling reported. The tolerability profile was comparable. However, the decentralised administration of sessions may have introduced inconsistent tDCS applications. Conclusions: This review highlights a lack of RCTs on tDCS for youth depression. Our pilot trial demonstrates the feasibility of a sham-controlled design in youth depression, justifying larger-scale trials to evaluate the efficacy of tDCS in this population. Full article

Background/Objectives: Depression is associated with an increased risk for the development and progression of cardiovascular disease. This research investigated the association between depressive symptoms and inflammation in the development of atherosclerotic coronary events. Methods: This retrospective observational study included 276 patients who were not previously diagnosed with atherosclerotic coronary artery disease at the beginning of the research. Participants were categorized using the Hamilton Depression Rating Scale (HDRS) and the Structured Clinical Interview for DSM-5 (SCID) into two groups: the depression group and the control group. Inflammatory biomarkers (C-reactive protein (CRP), fibrinogen, interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and cortisol) were measured at the beginning of the study, as well as at six months, one year, and two years. Results: Among patients with mild depression (17.3% vs. 4.2%) or moderate depression (15.4% vs. 6.7%), there were significantly more men than women, while among patients with very severe depression, there were significantly more women than men (21.7% vs. 11.5%). Participants with depression showed significantly higher increases at 2 years compared to baseline for all investigated parameters (p < 0.001). Depressed patients were significantly associated with an acute coronary syndrome (p = 0.038). Conclusions: This research highlights that individuals with depression face a greater risk of developing an acute coronary syndrome than those without depression. Full article

In western countries, the COVID-19 pandemic represented a unique scenario of a global threat of contagion of a life-threatening illness, as confirmed by the need for exceptional and never adopted measures represented by national lockdowns. This study aimed to investigate peritraumatic distress in the framework of the lockdown and to measure the impact on the course of depressive symptoms during the “first wave” of the COVID-19 pandemic in Italy. A sample of 131 subjects (52.7% females; mean age 47.0 ± 15.9 years), looking for a first or follow-up psychiatric visit at the outpatient psychiatric services of two Italian university hospitals, was recruited between 1 June 2020 and 30 July 2020 and assessed by the Hamilton Rating Scale for Depression (HAM-D) and the Peritraumatic Distress Inventory (PDI) at the time of enrolment in the study (T0). The HAM-D was administered again after 3 months (T1). Higher PDI scores significantly predicted the persistence or worsening of depressive symptoms. These results give further evidence of the possible interplay between peritraumatic distress and depressive symptoms in the framework of a global health threat such as the COVID-19 pandemic. Full article

Background. Sleep disturbances are frequent in patients with substance use disorders (SUDs) and are associated with craving and addiction relapses, leading to increased clinical severity and detrimental outcomes. Daridorexant, a selective dual orexin receptor antagonist, has been approved for persistent insomnia disorder (ID), but specific insights on patients with SUDs are lacking. Methods. This observational, retrospective study investigated the effects of a three-month treatment with daridorexant (50 mg/day) in 41 outpatients with comorbid IDs and SUDs. Improvement in subjective sleep measures, assessed with the Insomnia Severity Index (ISI) and subjective total sleep time, was the primary outcome measure. Changes in anxiety and depression symptoms, quality of life, clinical global severity, and craving were also investigated through the following: Hamilton Anxiety and Depression Rating Scale; Five-item World Health Organization Well-Being Index; Clinical Global Impression Severity Scale; Visual Analog Scale for Craving. Results. All sleep outcomes significantly improved throughout treatment, which was generally safe and well tolerated, with mild and transient drowsiness and sluggishness reported in 21.1% of patients. Similar improvements were observed in psychopathology, quality of life, and craving, and positive correlations were found among ISI scores and anxiety/depression symptoms and craving. An abstinence rate (i.e., absence of any substance use, regardless of the amount, throughout treatment) of 65.8% was also detected at the endpoint. Conclusions. These preliminary findings suggest that daridorexant might represent a promising tool for treating insomnia in patients with SUDs. Identifying interventions effectively targeting insomnia with a good safety/tolerability profile in SUDs is crucial to achieve remission and full functional recovery. Full article