Addressing the Triple Trauma of Factors Leading to Perinatal Health and Mental Health Consequences in Two Upstate New York Communities.

This article focuses on the impact of trauma experienced by individuals, families and groups, and neighborhoods in Rochester and Syracuse, New York. Using the levels of analysis put forward in Bronfenbrenner's ecological systems theory (i.e.

The Impact of Xanomeline and Trospium Chloride on Cognitive Impairment in Acute Schizophrenia: Replication in Pooled Data From Two Phase 3 Trials.

Objective: Xanomeline and trospium chloride (formerly known as KarXT), a novel M/M muscarinic receptor agonist, demonstrated efficacy across phase 2 and 3 trials as monotherapy for the treatment of inpatients with acute schizophrenia on the Positive and Negative Syndrome Scale total score primary endpoint. In the phase 2 trial, xanomeline/trospium improved performance on a cognitive outcome measure in the subgroup of participants with clinically significant baseline cognitive impairment. The authors sought to confirm this finding using data from two phase 3 trials.

Migration of digital functional capacity assessments from device resident to cloud-based delivery: Development and convergent validity.

Decentralized clinical trials are leading to rapid changes in assessment technology, including an expansion of interest in remote delivery. As technology changes, some of the updates include migration to fully cloud-based software and data management, with attendant differences in hardware, response modalities, and modifications in the level of tester engagement. It is rare to see systematic descriptions of the process of migration and upgrading of technology-related assessments.

Location-based differences in cognition and functional capacity: Consistent levels of impairment in participants with schizophrenia compared to healthy controls.

Cognitive performance manifests regional differences, correlated with education. There is less information available about regional differences in performance-based measures of functional capacity. In multi-national trials focused on cognitive enhancement, it may be impossible to validate every measure in all locations.

State Implementation of Congregate Care Reforms for Children in Foster Care.

Objectives: The Family First Prevention Services Act (FFPSA) allows states to use federal Title IV-E funds to provide time-limited, clinically appropriate use of congregate care, including Qualified Residential Treatment Programs (QRTPs), for youth in foster care. October 1, 2021 marked the deadline for states to begin implementing these FFPSA congregate care reforms. From June to September 2022, we conducted a mixed-methods study to obtain a baseline understanding of implementation barriers, successes, and recommendations to inform congregate care policy and practice.

Current and Emerging Technologies to Address the Placebo Response Challenge in CNS Clinical Trials: Promise, Pitfalls, and Pathways Forward.

Excessive placebo response rates have long been a major challenge for central nervous system (CNS) drug discovery. As CNS trials progressively shift toward digitalization, decentralization, and novel remote assessment approaches, questions are emerging about whether innovative technologies can help mitigate the placebo response. This article begins with a conceptual framework for understanding placebo response.

Qualitative Analysis of the Content Validity of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) in Schizophrenia: A Multi-Stakeholder Perspective.

The US Food and Drug Agency (FDA) requires clinical trials targeting cognitive impairment associated with schizophrenia (CIAS) to demonstrate the functional relevance of cognitive improvements by employing a functional co-primary measure. Although quantitative evidence supports the suitability of the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) for this purpose, FDA guidelines for qualification of clinical outcome assessments require evidence of content validity, defined as qualitative evidence that key stakeholders view the measure as relevant and important. To collect this important qualitative data, semi-structured interviews were conducted with outpatients with schizophrenia ( = 24), caregivers ( = 12), and professional peer support specialists ( = 12) to elicit their views about the definition and importance of functional independence, the importance of the functional domains assessed by the VRFCAT (meal planning, using transportation, handling money, shopping), and the relevance of the VRFCAT tasks to these domains.

Innovative Technologies in CNS Trials: Promises and Pitfalls for Recruitment, Retention, and Representativeness.

Objective: Recruitment of a sufficiently large and representative patient sample and its retention during central nervous system (CNS) trials presents major challenges for study sponsors. Technological advances are reshaping clinical trial operations to meet these challenges, and the COVID-19 pandemic further accelerated this development.

Method Of Research: The International Society for CNS Clinical Trials and Methodology (ISCTM; www.

Using latent profile analyses to classify subjects with anhedonia based on reward-related measures obtained in the FAST-MAS study.

Background: Growing evidence indicates that anhedonia is a multifaceted construct. This study examined the possibility of identifying subgroups of people with anhedonia using multiple reward-related measures to provide greater understanding the Research Domain Criteria's Positive Valence Systems Domain and pathways for developing treatments.

Methods: Latent profile analysis of baseline data from a study that examined the effects of a novel kappa opioid receptor (KOR) antagonist drug on measures and biomarkers associated with anhedonia was used to identify subgroups.

Psychotropic Medication Prescribing: Youth in Foster Care Compared with Other Medicaid Enrollees.

To compare the prevalence of psychotropic medication prescriptions among youth in foster care with those among nonfoster youth on Medicaid. Children ages 1-18 years in a region of a large southern state who were enrolled in their respective Medicaid plan for at least 30 days between 2014 and 2016 and had at least one health care claim were included. Medicaid prescription claims were categorized by class: alpha agonists, anxiolytics, antidepressants, antipsychotics, mood stabilizers, and stimulants.

Peripheral inflammation is associated with impairments of inhibitory behavioral control and visual sensorimotor function in psychotic disorders.

Elevated markers of peripheral inflammation are common in psychosis spectrum disorders and have been associated with brain anatomy, pathology, and physiology as well as clinical outcomes. Preliminary evidence suggests a link between inflammatory cytokines and C-reactive protein (CRP) with generalized cognitive impairments in a subgroup of individuals with psychosis. Whether these patients with elevated peripheral inflammation demonstrate deficits in specific cognitive domains remains unclear.

Antipsychotic drugs and their effects on cognitive function: protocol for a systematic review, pairwise, and network meta-analysis.

Background: There is evidence that antipsychotic drugs differ in their effect on the cognitive symptoms of schizophrenia. So far, there is no comprehensive systematic review available that would enable providers and patients to make informed choices regarding this important aspect of treatment. With a large number of substances available, conventional pairwise meta-analyses will not be sufficient to inform this choice.

Validation of a suite of ERP and QEEG biomarkers in a pre-competitive, industry-led study in subjects with schizophrenia and healthy volunteers.

Objective: Complexity and lack of standardization have mostly limited the use of event-related potentials (ERPs) and quantitative EEG (QEEG) biomarkers in drug development to small early phase trials. We present results from a clinical study on healthy volunteers (HV) and patients with schizophrenia (SZ) that assessed test-retest, group differences, variance, and correlation with functional assessments for ERP and QEEG measures collected at clinical and commercial trial sites with standardized instrumentation and methods, and analyzed through an automated data analysis pipeline.

Methods: 81 HV and 80 SZ were tested at one of four study sites.

Risk for psychiatric and substance use disorders as a function of transitions in Sweden's public educational system: a national study.

Background: To clarify, in a national sample, associations between risk for seven psychiatric and substance use disorders and five key transitions in Sweden's public educational system.

Methods: Swedish-born individuals (1972-1995, = 1 997 910) were followed through 12-31-2018, at mean age 34.9.

Impact of Cognitive Impairments on Health-Related Quality of Life in Schizophrenia.

The impact of cognitive impairments on the health-related quality of life (HRQoL) in individuals with schizophrenia is unclear. The aim of this study was to examine the association between cognitive impairments and HRQoL in individuals with schizophrenia. A total of 609 individuals with schizophrenia were assessed on the Positive and Negative Syndrome Scale (PANSS) and a neurocognitive battery which comprised of the Wechsler Abbreviated Scale of Intelligence matrix reasoning, the Benton Judgment of Line Orientation Test, Continuous Performance Tests-Identical Pairs, and the Brief Assessment of Cognition in Schizophrenia.

Cognitive impairment in schizophrenia: aetiology, pathophysiology, and treatment.

Cognitive deficits are a core feature of schizophrenia, account for much of the impaired functioning associated with the disorder and are not responsive to existing treatments. In this review, we first describe the clinical presentation and natural history of these deficits. We then consider aetiological factors, highlighting how a range of similar genetic and environmental factors are associated with both cognitive function and schizophrenia.

Lost in the woods: Forest vegetation, and not topography, most affects the connectivity of mesh radio networks for public safety.

Real-time data- and location-sharing using mesh networking radios paired with smartphones may improve situational awareness and safety in remote environments lacking communications infrastructure. Despite being increasingly used for wildland fire and public safety applications, there has been little formal evaluation of the network connectivity of these devices. The objectives of this study were to 1) characterize the connectivity of mesh networks in variable forest and topographic conditions; 2) evaluate the abilities of lidar and satellite remote sensing data to predict connectivity; and 3) assess the relative importance of the predictive metrics.

BCG vaccinations drive epigenetic changes to the human T cell receptor: Restored expression in type 1 diabetes.

The BCG (Bacille Calmette-Guérin) vaccine, introduced 100 years ago for tuberculosis prevention, has emerging therapeutic off-target benefits for autoimmunity. In randomized controlled trials, BCG vaccinations were shown to gradually improve two autoimmune conditions, type 1 diabetes (T1D) and multiple sclerosis. Here, we investigate the mechanisms behind the autoimmune benefits and test the hypothesis that this microbe synergy could be due to an impact on the host T cell receptor (TCR) and TCR signal strength.

Dispersion of cognitive performance test scores on the MATRICS Consensus Cognitive Battery: A different perspective.

Objective: Persons with schizophrenia exhibit greater neurocognitive test score dispersion. Here, we seek to characterize dispersion on the Neurocognitive Composite subtests of the Measurement of Treatment Research to Improve Cognition in Schizophrena Consensus Cognitive Battery (MCCB) and determine the relative effects of different antipsychotic formulations on dispersion and mean performance.

Method: In this post hoc analysis of the DREaM study (NCT02431702), which compared treatment with paliperidone palmitate (PP) long-acting injectable with oral antipsychotic (OAP) treatment over 18 months, dispersion in MCCB neurocognitive subtest performance was calculated for each participant by visit (test occasion).

Evaluating how treatment adherence influences cognitive remediation outcomes.

Background: There is evidence that Cognitive Remediation (CR) is an efficacious approach to reduce cognitive and functioning difficulties in people with schizophrenia. However, there is still a limited understanding of what influences different treatment responses. Treatment adherence has been suggested as one factor but has not been investigated systematically.

Remote self-administration of digital cognitive tests using the Brief Assessment of Cognition: Feasibility, reliability, and sensitivity to subjective cognitive decline.

Cognitive impairment is a common and pervasive feature of etiologically diverse disorders of the central nervous system, and a target indication for a growing number of symptomatic and disease modifying drugs. Remotely acquired digital endpoints have been recognized for their potential in providing frequent, real-time monitoring of cognition, but their ultimate value will be determined by the reliability and sensitivity of measurement in the populations of interest. To this end, we describe initial validation of remote self-administration of cognitive tests within a regulatorily compliant tablet-based platform.