Journal of Clinical Psychopharmacology最新文献

Purpose: Women have historically been underrepresented in second-generation antipsychotic (SGA) clinical trials, accounting for less than 35% of participants, which raises concerns about the generalizability of the safety profile for these medications.

Methods: The US adverse event reporting system was queried for the dates January 1, 2019, to July 8, 2024, to examine the following 6 SGAs: aripiprazole, clozapine, olanzapine, quetiapine, risperidone, and ziprasidone. Reports were excluded if patients were under 18 years old, contained an unknown age or gender, or were duplicated. Five adverse events were examined: Torsades de pointes (TdP), neuroleptic malignant syndrome (NMS), tardive dyskinesia (TD), agranulocytosis (AG), and cerebrovascular adverse events (CVAE). Counts of these events were noted, and reporting odds ratios (ROR) were calculated.

Results: The total study cohort was 87,356 reports, consisting of aripiprazole (n = 10,715, 12.2%), clozapine (n = 25,096, 28.7%), olanzapine (n = 11,587, 13.3%), quetiapine (n = 28,746, 32.9%), risperidone (n = 10,467, 12%), and ziprasidone (n = 745, 0.9%). The cohort's mean age was 48.6 ± 18.5 years and comprised 42,584 females (48.7%). Most cases were reported by healthcare professionals (74,836, 85.7%). A total of 3,754 reports contained at least 1 of the 5 adverse events. The RORs among females compared to males for TdP (5.55, 95% confidence interval [CI] = 3.78-8.47), NMS (0.59, 95% CI = 0.53-0.65), TD (0.88, 95% CI = 0.76-1.02), AG (0.59, 95% CI = 0.51-0.70), and CVAE (1.12, 95% CI = 0.89-1.41) were observed. Females had a significantly higher odds of hospitalization or death with TdP compared to males (ROR = 3.09, 95% CI = 1.36-7.01).

Conclusions: Our findings suggest higher odds of TdP and worse TdP-associated outcomes among females exposed to SGAs compared to males. Further studies are needed to confirm these preliminary findings.

Background: In recent years, there has been a significant focus on exploring the potential therapeutic impact of altered states of consciousness on treatment outcomes for mental illness, with the goal of enhancing therapeutic strategies and patient results.

Methods: This meta-analysis was designed to investigate the potential link between the psychomimetic effects of ketamine and clinical outcomes in mental health, which adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.

Results: Eleven studies were selected for meta-analysis, and the main result did not find a significant correlation between the psychoactive effects of ketamine and clinical outcomes either in mental illness (n = 11; n's = 27; r = 0.06 [-0.05, 0.17]; P = 0.268) or depression exclusively (n = 10; n's = 25; r = 0.03 [-0.07, 0.13]; P = 0.561). High heterogeneity was found for general analysis ( I2 = 80.78). Egger's regression did not indicate publication bias (intercept = 1.57; SE = 1.49, P = 0.30). No significant Kendall's rank correlation coefficient was observed ( τ = 0.02, P = 0.88) indicating funnel plot symmetry. The sub-analyses, aimed at minimizing study variability by specifically examining factors such as patient disorders (limited to depression), methods of administration (exclusively intravenous), types of assessment instruments, and the timing of evaluations, also yielded no significant findings.

Conclusion: This meta-analysis suggests that the altered states of consciousness experienced during ketamine sessions are not directly linked to clinical outcomes. However, it is important to acknowledge that the limited number of studies and their heterogeneity render this conclusion preliminary, warranting further investigation over time.

Purpose/background: The antipsychotic class of medications has a varying degree of peripheral alpha antagonism resulting vasodilation and potentially hypotension. These hemodynamic changes may require treatment with crystalloids and vasopressors. The primary aim of this study was to evaluate the occurrence of hypotension after antipsychotic overdose and characterize vasopressor use.

Methods/procedures: A retrospective cohort study was conducted by chart review of electronic records from 2 regional poison centers from January 1, 2004, to December 31, 2020. Inclusion criteria were single acute antipsychotic exposures evaluated in a health care facility and age >15. Exclusion criteria included missing data, minor or no effect outcomes, and polypharmacy overdose. The primary outcome was hypotension, which was defined as systolic blood pressure <90 mm Hg and/or MAP <65.

Findings/results: There were 4488 single acute antipsychotic overdoses that presented to a healthcare facility after the initial search was conducted. After exclusions, there were 2070 cases with moderate or severe outcomes. The mean age was 42 (SD = 16), and 70% were female. There were 169 cases with hypotension. Of the hypotensive cases, 92% involved atypical antipsychotics, with quetiapine being the most common (n = 128, 76%). Vasopressor therapy was administered in 16/169 cases (9.9%). In the cases where vasopressor use was recorded, norepinephrine was used 12 times, dopamine 3 times, and phenylephrine once. No deaths were reported.

Implications/conclusions: In antipsychotic overdoses that presented to a healthcare facility, hypotension was present in n = 169 (3.8%).

Conclusions: Among patient reports to 2 regional poison centers, we found that hypotension following acute antipsychotic overdose was infrequent and vasopressors are rarely administered.

Background: The objective of this study was to examine the characteristics of adverse drug reactions of duloxetine and investigate the potential precautions that may exist beyond the drug label.

Methods: This study used data from the Food and Drug Administration Adverse Event Reporting System database 2004-2023 and the linked information of duloxetine. Four algorithms used to evaluate the correlation between duloxetine and adverse events include reporting odds ratio, proportional reporting ratio, Bayesian confidence propagation neural network, and multi-item gamma Poisson shrinker.

Results: Adverse reactions involving duloxetine were associated with 24 System Organ Classes. Among them, the three most frequent systems affected were psychiatric disorders (reporting odds ratio [ROR] 5.05), nervous system disorders (ROR 2.27), and general medical conditions and administration site conditions (ROR 0.83). Of particular note, the number of reported cases and the risk of occurrence of adverse events of drug withdrawal syndrome (n = 7498), nausea (n = 7942), and headache (n = 5732) were the highest, increasing each year and reached a peak submission in 2017. More importantly, the occurrence of reproductive system and breast disorders (chisq 317.85) was not mentioned in the drug leaflet.

Conclusions: Psychiatric and nervous system disorders are the most frequently reported adverse events associated with duloxetine, with drug withdrawal syndrome, nausea, and headache being especially common. The emergence of mood-related symptoms, such as agitation and irritability, underscores the need for vigilant monitoring of mental health. Additionally, potential risks affecting the reproductive system suggest areas for further attention. These findings highlight the importance of proactive monitoring to improve patient safety during duloxetine treatment.