The olanzapine/samidorphan (OLZ/SAM) combination is being regarded as a new strategy to combat weight gain induced by olanzapine (OLZ), and its safety is of significant concern. Specifically, as samidorphan is an opioid receptor-related drug, issues related to its potential for dependence and withdrawal symptoms deserve attention. This study aims to provide a comprehensive analysis of adverse events (AEs) associated with the OLZ/SAM. This study is a pharmacovigilance study based on the analysis of reports from the FDA Adverse Event Reporting System (FAERS) utilizing the Openvigil online analysis platform for the period from January 1, 2023, to June 30, 2024. Signal results were reported as Reporting Odds Ratios (ROR) along with 95% confidence intervals. A binary logistic regression model was used to analyze the association between the OLZ/SAM and specific AEs. This study included 86 reports of AEs associated with the OLZ/SAM and 4,678 reports related to OLZ. In terms of frequency of OLZ/SAM-related AEs, off-label use (N = 12) and drug withdrawal syndrome (N = 11) were reported most frequently. Among various system organ classes, the highest frequency of AEs was observed in neurological disorders (SOC) (N = 23). We identified 15 signals associated with the OLZ/SAM. The results of the stepwise regression analysis indicated that in all models, the OLZ/SAM was significantly associated with drug withdrawal syndrome when compared to OLZ (p < 0.01). The long-term safety of the OLZ/SAM warrants attention, particularly concerning drug withdrawal syndrome.

Currently, research predominantly focuses on evaluating clinical effects at specific time points while neglecting underlying patterns within the treatment process. This study aims to analyze the dynamic alterations in PANSS total scores and prolactin levels in patients with schizophrenia treated with risperidone, along with the influencing covariates. Using data from an 8-week randomized, double-blind, multicenter clinical trial, a population pharmacodynamic model was established for the PANSS total scores of and prolactin levels in patients treated with risperidone. The base model employed was the E_max model. Covariate selection was conducted using a stepwise forward inclusion and backward elimination approach. A total of 144 patients were included in this analysis, with 807 PANSS total scores and 531 prolactin concentration values. The PANSS total scores of the patients treated with risperidone decreased over time, fitting a proportionally parameterized sigmoid E_max model with covariates including baseline score, course of the disease, gender, plasma calcium ions, and lactate dehydrogenase levels. The increase in prolactin levels conformed to the ordinary E_max model, with covariates encompassing course of the disease, gender, weight, red blood cell count, and triglyceride levels. The impacts of the baseline scores and the course of the disease on the reduction of the PANSS scores, as well as the influence of gender on the elevation of prolactin levels, each exceeded 20%. This study provides valuable quantitative data regarding PANSS total scores and prolactin levels among patients undergoing risperidone treatment across various physiological conditions.

Background: Major depressive disorder is the second leading cause of years lost to disability worldwide. Anyu Peibo Capsule has been shown to be effective and safe in phase II trials. Methods: This clinical study is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group, phase III trial of Anyu Peibo Capsule in China. The aim is to test whether the administration of Anyu Peibo Capsule compared to placebo improves clinical outcomes in adults (aged 18 to 65 years) with MDD. Patients will receive an 8-week treatment of Anyu Peibo Capsule 1.6 g per day or placebo. The primary outcome will be the change from baseline in the total score for the Montgomery-Asberg Depression Rating Scale at the end of the 8-week treatment. Discussion: The trial aims to provide pivotal evidence for the efficacy and safety of Anyu Peibo Capsule in patients with major depressive disorder. Trial registration: ClinicalTrials.gov NCT04210973. Registered on December 26, 2019

Background: In clinical practice, selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) remain commonly used owing to their proven antidepressant efficacy, however, they are also associated with a considerable risk of sexual adverse effects. Aim: To examine the relationship between individual SSRIs/SNRIs and distinct sexual dysfunction symptoms. Methods: Using the Food and Drug Administration's Adverse Event Reporting System (FAERS) database, we performed a pharmacovigilance analysis of adverse drug events. Disproportionality signals were detected using reporting odds ratios (RORs) and information components (ICs), with Bayesian shrinkage transformation applied to mitigate random variability. Outcomes: The primary outcome indicators are RORs and ICs, which were employed to evaluate the association between SSRIs and SNRIs and the development of sexual dysfunction. Results: Comparative analysis of antidepressant-related adverse events in the FAERS database showed that while sexual dysfunction was associated with all studied SSRIs/SNRIs (sertraline, citalopram/escitalopram, paroxetine, fluoxetine, venlafaxine, and duloxetine), symptom profiles varied markedly. Sertraline presented the most diverse array of sexual dysfunction manifestations, contrasting with duloxetine’s relatively restricted adverse effect profile. Clinical Implications: This study provides valuable real-world evidence to assist clinicians in optimizing antidepressant selection, proactively identifying high-risk populations for sexual dysfunction, and improving patient compliance and quality of life during antidepressant treatment. Strengths and Limitations: The use of FAERS offers large-scale real-world data on antidepressant-related sexual dysfunction to enhance generalizability. But the limitation is FAERS' passive surveillance nature, which may involve underreporting or insufficient clinical context, restricting causal inference. Conclusion: While previous studies have not fully elucidated antidepressant-related sexual dysfunction, our findings delineate distinct sexual adverse effect profiles between SSRIs and SNRIs, contributing valuable evidence for personalized treatment approaches.