Pharmacovigilance in Action: Utilizing VigiBase Data to Improve Clozapine Safety.

Purpose: Clozapine is an antipsychotic which was approved in 1989 for treatment-resistant schizophrenia in the United States (US). There were few randomized trials before its approval and potentially lethal clozapine adverse drug reactions (ADRs), such as agranulocytosis and myocarditis were identified by pharmacovigilance. VigiBase, the WHO global database, is a cornerstone of international pharmacovigilance efforts for ADR identification during post-marketing surveillance.

Exploring the Relationship Between Psychological Constructs and Decision-Making Preferences in Psychiatric Outpatients.

Objective: This study aimed to elucidate the relationships among health locus of control, psychological reactance, attitudes toward psychiatric treatment, and patient decision-making preferences within a psychiatric outpatient population.

Methods: A total of 200 consecutive psychiatric outpatients from a community mental health center in Tenerife, Spain, were approached for participation between September 2023 and March 2024. Of these, 151 patients consented to participate in this cross-sectional study.

How clinical decision tasks modulate emotional related EEG responses in nursing students.

Healthcare professionals play a vital role in conveying sensitive information as patients undergo stressful, demanding situations. However, the underlying neurocognitive dynamics in routine clinical tasks remain underexplored, creating gaps in healthcare research and social cognition models. Here, we examined whether the type of clinical task may differentially affect the emotional processing of nursing students in response to the emotional reactions of patients.

The subcortical default mode network and Alzheimer's disease: a systematic review and meta-analysis.

The default mode network is a central cortical brain network suggested to play a major role in several disorders and to be particularly vulnerable to the neuropathological hallmarks of Alzheimer's disease. Subcortical involvement in the default mode network and its alteration in Alzheimer's disease remains largely unknown. We performed a systematic review, meta-analysis and empirical validation of the subcortical default mode network in healthy adults, combined with a systematic review, meta-analysis and network analysis of the involvement of subcortical default mode areas in Alzheimer's disease.

"Superheroes? No, thanks." Accepting vulnerability in healthcare professionals.

In this commentary, we develop a conceptual proposal aimed to explain why a discourse of praise and admiration for healthcare professionals´ limitless dedication can trigger a general indifference to the burnout and suffering they experience. Ultimately, this can lead to the justification of the lack of resources dedicated to preventing these problems. We first start by pointing out the stigmatisation of healthcare professionals suffering from burnout and showing their vulnerability, highlighting the complex interactions that occur in the healthcare context and that increase the risk of perpetuating their suffering.

Electrophysiological alterations during action semantic processing in Parkinson's disease.

Assessments of action semantics consistently reveal markers of Parkinson's disease (PD). However, neurophysiological signatures of the domain remain under-examined in this population, especially under conditions that allow patients to process stimuli without stringent time constraints. Here we assessed event-related potentials and time-frequency modulations in healthy individuals (HPs) and PD patients during a delayed-response semantic judgment task involving related and unrelated action-picture pairs.

Psychometric properties of the CEMA-A questionnaire: motives for lying.

Previous research on the motives for lying lacks factorial models that allow grouping of motives into specific categories. The objective of this study is to confirm the factorial structure of the questionnaire of motives for lying (CEMA-A). Participants were 1,722 adults residing in the Canary Islands (Spain) who completed the CEMA-A and the Eysenck Personality Questionnaire (EPQ-R).

Amantadine and/or transcranial magnetic stimulation for fatigue associated with multiple sclerosis (FETEM): study protocol for a phase 3 randomised, double-blind, cross-over, controlled clinical trial.

Introduction: Fatigue is one of the most disabling symptoms of multiple sclerosis (MS), and effective treatments are lacking. Amantadine is one of the most used treatments, although its efficacy is under debate. Transcranial magnetic stimulation (TMS) is a promising intervention that has shown positive effects in some preliminary investigations.

Task-related modulation of motor response to emotional bodies: A TMS motor-evoked potential study.

Exposure to emotional body postures during perceptual decision-making tasks has been linked to transient suppression of motor reactivity, supporting the monitoring of emotionally relevant information. However, it remains unclear whether this effect occurs implicitly, i.e.

Revealing the reporting disparity: VigiBase highlights underreporting of clozapine in other Western European countries compared to the UK.

Background: Pharmacovigilance studies indicate clozapine history is marked by adverse drug reactions (ADRs).

Objective: In a 2021 article, the United Kingdom (UK) had >90 % of European clozapine-related fatal outcomes in VigiBase, the World Health Organization's pharmacovigilance database. Two possibly opposing hypotheses could explain this disparity: 1) fewer reported fatal outcomes in other Western European countries mainly reflect underreporting to VigiBase, and 2) the higher number of UK reports reflects higher real relative mortality.

An expert review of clozapine in Latin American countries: Use, monitoring, and pharmacovigilance.

There is growing interest in clozapine clinical use, monitoring, and research, particularly adverse drug reactions (ADRs) other than agranulocytosis. In this study we focused on clozapine pharmacovigilance. Hence, we contacted clinicians and researchers in Latin America and requested information about local psychiatric services, clozapine availability, clinical use, and ADR monitoring with the VigiBase system.

Clozapine-associated pericarditis and pancreatitis in children and adolescents: A systematic literature review and pharmacovigilance study using the VigiBase database.

Background: The literature has paid very little attention to pericarditis, pericardial effusion and pancreatitis during clozapine treatment in children and adolescents.

Methods: Cases of clozapine-associated pericarditis and pancreatitis in children were studied using searches in: 1) PubMed (June 16, 2023), and 2) the World Health Organization's pharmacovigilance database (June 1, 2022), VigiBase. VigiBase uses a logarithmic measure of disproportionality called the information component (IC).

Telepsychiatry: The future is already present.

This review paper analyzes the state of knowledge on Telepsychiatry (TP) after the crisis caused by COVID and the resulting need to use new modalities of care. Six essential aspects of TP are addressed: patient's and mental health staff satisfaction, diagnostic reliability, effectiveness of TP interventions, cost-effectiveness in terms of opportunity cost (or efficiency), legal aspects inherent to confidentiality and privacy in particular and the attitude of professionals toward TP. Satisfaction with TP is acceptable among both patients and professionals, the latter being the most reluctant.

Will ChatGPT3 Substitute for us as Clozapine Experts?

Background: ChatGPT3 is a new artificial intelligence program released on February 13, 2023.

Method: The authors tested ChatGPT3 on February 18, 2023, and repeated the test a week later. They used their expertise on the effects of ethnic ancestry in the stratification of clozapine dosing and the new idea that they published in March 2022 that African-Americans need higher clozapine doses because they have higher clozapine clearance.

The Access to Grammatical Number in Spanish Children and Adults.

In Spanish, the plural form in plural dominant frequency pairs, like "diente/dientes" [tooth/teeth], occurs more frequently than the corresponding singular form. On the other hand, for the singular dominant frequency pairs such as "cometa/cometas" [kite/kites], the singular form is more common than the plural. The recognition of singular forms by adult readers is dependent on the dominance factor, while the identification of plural forms relies on the frequency of the stem.

Exploring low clozapine C/D ratios, inverted clozapine-norclozapine ratios and undetectable concentrations as measures of non-adherence in clozapine patients: A literature review and a case series of 17 patients from 3 studies.

Background: Up to 1/2 of outpatients prescribed clozapine may be partially/fully non-adherent, based on therapeutic drug monitoring (TDM). Three indices for measuring partial/full non-adherence are proposed a: 1) clozapine concentration/dose (C/D) ratio which drops to half or more of what is expected in the patient; 2) clozapine/norclozapine ratio that becomes inverted; and 3) clozapine concentration that becomes non-detectable.

Methods: These 3 proposed indices are based on a literature review and 17 cases of possible non-adherence from 3 samples: 1) an inpatient study in a Chinese hospital, 2) an inpatient randomized clinical trial in a United States hospital, and 3) and a Uruguayan outpatient study.

Disturbing the activity of the primary motor cortex by means of transcranial magnetic stimulation affects long term memory of sentences referred to manipulable objects.

Introduction: Previous studies on embodied meaning suggest that simulations in the motor cortex play a crucial role in the processing of action sentences. However, there is little evidence that embodied meaning have functional impact beyond working memory. This study examines how the neuromodulation of the motor cortex (M1) could affect the processing of action-related language, measuring participants' performance in a long-term memory task.

Psychiatric Patients' Perceived Health Control and Reactance: Implications for Medication Adherence.

Adherence to prescribed treatment is a major challenge in psychiatry, with non-adherence rates estimated to be as high as 50%. Two factors that have been suggested to influence medication adherence in psychiatric patients are perceived health control and psychological reactance. Perceived health control refers to the belief that one can control their own health outcomes, while psychological reactance refers to the negative response that occurs when individuals perceive their freedom or autonomy to be threatened.