Post-marketing safety concerns with lumateperone: a pharmacovigilance analysis based on the FDA adverse event reporting system (FAERS) database.

Objective: Lumateperone, a novel antipsychotic drug that was granted by the Food and Drug Administration (FDA) approval in December 2019, remains insufficiently explored for its adverse event profile. This study used the FDA Adverse Event Reporting System (FAERS) database to explore its potential safety issues. Methods: This study conducted a retrospective analysis of FAERS data from the fourth quarter of 2019 to the third quarter of 2023, extracting reports related to lumateperone. Disproportionality analysis using Reporting Odds Ratio (ROR) and Bayesian Confidence Propagation Neural Network (BCPNN) algorithms was employed to detect signals of adverse events (AEs). Results: Our research processed 4,777 pertinent AE disclosures related to lumateperone, unveiling 125 signals that satisfied both ROR and BCPNN evaluative benchmarks across 26 System Organ Classes (SOCs). Intriguingly, 108 of these signals were categorized as unanticipated, spotlighting notable psychiatric manifestations such as mania (ROR = 73.82, 95% CI = 57.09-95.46; IC = 6.16, IC025 = 4.49), and hypomania (ROR = 34.74, 95% CI = 15.54-77.64; IC = 5.10, IC025 = 3.43), alongside non-psychiatric phenomena like urinary retention (ROR = 3.59, 95% CI = 1.80-7.19; IC = 1.84, IC025 = 0.18) and serotonin syndrome (ROR = 8.69, 95% CI = 4.81-15.72; IC = 3.11, IC025 = 1.45). Conclusion: This research provides real-world safety data on lumateperone post-marketing and is an important supplement to the information from clinical trial studies. Healthcare professionals should be vigilant for the risk of a manic switch in patients with bipolar depression who are administered lumateperone. More epidemiological studies are needed in the future to explore and further evaluate the risk-benefit issue of lumateperone.

A 28-Year-Old Man with Obsessive-Compulsive Disorder, Post-Traumatic Stress Disorder, and Dissociative Identity Disorder Responding to Aripiprazole Augmentation of Clomipramine Combined with Psychoeducation and Exposure and Response Prevention.

BACKGROUND We report the case of a 28-year-old man with comorbidity of OCD, PTSD, and DID responding to aripiprazole augmentation of clomipramine combined with psychoeducation and exposure and response prevention (ERP). CASE REPORT A 28-year-old, well-educated man presented with depression, obsessive thoughts, behavioral impulsivity, and suicidal thoughts/behavior. He was known to be stubborn and sensitive to criticism since childhood. The obsessive thoughts and compulsive behaviors also started at an early age. He had 4 past psychiatric hospitalizations, mostly for dissociative episodes and bizarre behaviors, complicated with significant anxiety and distress from traumatic experiences during doctoral study. He had no-to-minimal responses to various psychotropics and traditional Chinese medicine. A thorough assessment showed he met the diagnostic criteria for OCD, PTSD, and DID. He was then treated with clomipramine in combination with aripiprazole, plus psychoeducation and exposure and response prevention (ERP). His anxiety and irritability significantly improved within 2 months and his obsessive thoughts faded away. At 6-month follow-up, the patient achieved clinical remission. One year later, he remained stable and reported having a normal life. CONCLUSIONS The case illustrates both how impairing the comorbidity of OCD, PTSD, and DID can be and how concurrent use of tricyclic antidepressant (TCA) clomipramine and partial dopamine agonist aripiprazole, together with psychoeducation and ERP, can improve outcomes when other treatment choices fail to be effective.

The Therapeutic Effect of Exogenous Melatonin on Depressive Symptoms: A Systematic Review and Meta-Analysis.

Background: Depression-related mortality and morbidity pose growing public health burdens worldwide. Although the therapeutic effect of exogenous melatonin on depression has been investigated, findings remain inconsistent. We conducted this systematic review and meta-analysis to clarify the effectiveness of melatonin in the treatment of depression, including primary and secondary depression symptoms. Methods: We searched the online databases of PubMed, EMBASE, and the Cochrane Library for original studies published up to May 2021. We used STATA 14.0 software to synthesize the results of included studies. To evaluate the effectiveness of melatonin, we calculated the standardized mean differences (SMDs) and 95% confidence intervals (CIs) of depression scores between the melatonin and placebo groups. Results: Our literature search returned 754 publications, among which 19 studies with 1,178 patients (715 women, 463 men; mean age: 56.77 years) met inclusion criteria. Melatonin dosages ranged from 2 to 25 mg per day; treatment durations were between 10 days and 3.5 years. Our synthesized results showed that melatonin was not found significantly beneficial for alleviating depressive symptoms (SMD = -0.17, 95% CI = [-0.38, 0.05]). Subgroup analysis demonstrated that the decrease in depression scores measured with the Beck Depression Inventory (BDI) was significant (SMD = -0.52, 95% CI = [-0.73, -0.31]). Conclusions: There is very limited evidence for effects of melatonin on depression.

Suboptimal health status and psychological symptoms among Chinese college students: a perspective of predictive, preventive and personalised health.

BACKGROUND: Suboptimal health status (SHS) is an intermediate health status between health and illness, a syndrome characterised by the perception of health complaints, general weakness and low energy. This study aimed to investigate the prevalence of SHS and the correlation between SHS and psychological symptoms among Chinese college students and to identify the SHS-related risk factors from the perspective of predictive, preventive and personalised medicine (PPPM). METHODS: A cross-sectional study was conducted among 4119 college students who were enrolled from Taishan Medical University and Baoji Vocational and Technical College in the eastern and western areas of China. SHS levels of the participants were measured by an established self-reporting Suboptimal Health Status Questionnaire-25 (SHSQ-25). Psychosomatic conditions were estimated by the self-rating Symptom Checklist-90 (SCL-90) scale. Spearman correlation analysis was applied to analyse the relationship between SHSQ-25 scores and SCL-90 estimates. Logistic regression analysis was applied for multivariate analysis. RESULTS: The prevalence of SHS was 21.0% (864/4119), with 23.3% (701/3005) for female students and 14.6% (163/1114) for male students. The prevalence of general positive psychological symptom was 14.2% (586/4119), with 15.6% (470/3005) for female students and 10.4% (116/1114) for male students. A strong correlation was identified between SHS score and SCL-90 estimates, with the correlation coefficient (r) of 0.719. Logistic regression showed that variables significantly associated with SHS were somatisation (adjusted odds ratio (aOR) = 3.185, 95% confidence interval [CI] = 2.048-4.953), obsessive-compulsive (aOR = 3.518, 95% CI = 2.834-4.368), interpersonal sensitivity (aOR = 1.883, 95% CI = 1.439-2.463) and depression (aOR = 1.847, 95% CI = 1.335-2.554). CONCLUSIONS: Our findings confirm that there is a high prevalence of SHS among college students and there is a strong association between SHS and psychological symptoms among Chinese college students. High susceptibility of SHS occurs particularly in vulnerable groups: female students, sophomore students, medical students and students from rural area. Identification of SHS and prompt application of personalised psychological health-supporting activities will promote college students' health status.

Association between circulating visfatin and gestational diabetes mellitus: a systematic review and meta-analysis.

AIMS: Gestational diabetes mellitus (GDM) is a medical complication of any degree of glucose intolerance with onset or first recognition during pregnancy. Although visfatin is commonly considered to be related to GDM, studies revealed inconsistent results. This study aimed to clarify the relationship between visfatin and GDM. METHODS: The protocol for this study was registered in PROSPERO (No. CRD42018086204) in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). PubMed and Embase databases were used to search for relevant studies published up to September 30, 2017. The difference of visfatin levels between women with GDM and the controls was measured by standardised mean difference (SMD) and 95% confidence interval (CI). RESULTS: Twenty-six studies that were published in 24 articles met the inclusion criteria, in which 2305 participants (1033 with GDM, mean age 31.39 years and 1272 controls, and mean age 29.99 years) were included. The quantitative meta-analysis revealed no significant difference in circulating visfatin levels between women with GDM and the controls (SMD = 0.249, 95% CI = - 0.079 to 0.576, P = 0.137). Subgroup analyses were performed referring to body mass index (BMI) where inconsistent results have been observed between cases and controls groups. For the ten studies, in which the level of BMI in women with GDM was higher than that in the control group, the pooled result showed that circulating visfatin was significantly higher among women with GDM than the controls (SMD = 0.367, 95% CI = 0.06 to 0.728, P = 0.046). Of other 16 studies BMI-matched, the pooled SMD illustrated no difference of visfatin. CONCLUSIONS: Our study elucidates that visfatin is not independently associated with GDM. Visfatin is linked to GDM through maternal overweight/obesity, which is one of the major factors leading to the development of GDM.

Neuroprotective effect of pretreatment with ganoderma lucidum in cerebral ischemia/reperfusion injury in rat hippocampus.

Ganoderma lucidum is a traditional Chinese medicine, which has been shown to have both anti-oxidative and anti-inflammatory effects, and noticeably decreases both the infarct area and neuronal apoptosis of the ischemic cortex. This study aimed to investigate the protective effects and mechanisms of pretreatment with ganoderma lucidum (by intragastric administration) in cerebral ischemia/reperfusion injury in rats. Our results showed that pretreatment with ganoderma lucidum for 3 and 7 days reduced neuronal loss in the hippocampus, diminished the content of malondialdehyde in the hippocampus and serum, decreased the levels of tumor necrosis factor-α and interleukin-8 in the hippocampus, and increased the activity of superoxide dismutase in the hippocampus and serum. These results suggest that pretreatment with ganoderma lucidum was protective against cerebral ischemia/reperfusion injury through its anti-oxidative and anti-inflammatory actions.