Conducting clinical trials with self-collection of pharmacokinetic samples: Experience from an exploratory, phase 1, open-label trial of centanafadine SR in healthy individuals.

Background: The COVID-19 pandemic accelerated a shift to decentralized clinical trials. We present the potential feasibility of this approach from a phase 1 pharmacokinetic (PK) trial.

Methods: Healthy adults (18-55 years) with a body mass index of 19.

Developing a Sleep Algxorithm to Support a Digital Medicine System: Noninterventional, Observational Sleep Study.

Background: Sleep-wake patterns are important behavioral biomarkers for patients with serious mental illness (SMI), providing insight into their well-being. The gold standard for monitoring sleep is polysomnography (PSG), which requires a sleep lab facility; however, advances in wearable sensor technology allow for real-world sleep-wake monitoring.

Objective: The goal of this study was to develop a PSG-validated sleep algorithm using accelerometer (ACC) and electrocardiogram (ECG) data from a wearable patch to accurately quantify sleep in a real-world setting.

Treatment Preferences of Physicians Treating Adult Patients with Attention-Deficit/Hyperactivity Disorder in the United States and Canada: A Discrete Choice Experiment.

Introduction: Factors influencing attention-deficit/hyperactivity disorder (ADHD) treatment preferences have been studied among patients but not physicians in the United States (US) and Canada. This study assessed treatment preferences of physicians treating adult patients with ADHD in both countries.

Methods: An online discrete choice experiment (DCE) was conducted (October 4-20, 2023) among physicians from Dynata's US and Canadian panel who treated adult patients with ADHD.

Real world analysis of treatment change and response in adults with attention-deficit/hyperactivity disorder (ADHD) alone and with concomitant psychiatric comorbidities: results from an electronic health record database study is the United States.

Background: The objectives of this study were to examine the association of psychiatric comorbidities and patient characteristics with treatment change and response as well as to assess the association between treatment change and healthcare resource utilization (HCRU) among adult patients with attention-deficit/hyperactivity disorder (ADHD) and psychiatric comorbidities.

Methods: De-identified electronic health records from the NeuroBlu Database (2002-2021) were used to select patients ≥ 18 years with ADHD who were prescribed ADHD-specific medication. The index date was set as the first prescription of ADHD medication.

A matching-adjusted indirect comparison of centanafadine versus lisdexamfetamine, methylphenidate and atomoxetine in adults with attention-deficit/hyperactivity disorder: long-term safety and efficacy.

To compare long-term safety and efficacy outcomes of centanafadine versus lisdexamfetamine dimesylate (lisdexamfetamine), methylphenidate hydrochloride (methylphenidate) and atomoxetine hydrochloride (atomoxetine), respectively, in adults with attention-deficit/hyperactivity disorder (ADHD) using matching-adjusted indirect comparisons (MAICs). Patient-level data from a centanafadine trial (NCT03605849) and published aggregate data from a lisdexamfetamine trial (NCT00337285), a methylphenidate trial (NCT00326300) and an atomoxetine trial (NCT00190736) were used. Patient characteristics were matched in each comparison using propensity score weighting.

Healthcare resource utilization and costs associated with psychiatric comorbidities in pediatric patients with attention-deficit/hyperactivity disorder: a claims-based case-cohort study.

Background: Attention-deficit/hyperactivity disorder (ADHD) has been shown to pose considerable clinical and economic burden; however, research quantifying the excess burden attributable to common psychiatric comorbidities of ADHD among pediatric patients is scarce. This study assessed the impact of anxiety and depression on healthcare resource utilization (HRU) and healthcare costs in pediatric patients with ADHD in the United States.

Methods: Patients with ADHD aged 6-17 years were identified in the IQVIA PharMetrics Plus database (10/01/2015-09/30/2021).

Risk factors associated with newly diagnosed attention-deficit/hyperactivity disorder in adults: a retrospective case-control study.

Background: Knowledge of risk factors for attention-deficit/hyperactivity disorder (ADHD) may facilitate early diagnosis; however, studies examining a broad range of potential risk factors for ADHD in adults are limited. This study aimed to identify risk factors associated with newly diagnosed ADHD among adults in the United States (US).

Methods: Eligible adults from the IQVIA PharMetrics® Plus database (10/01/2015-09/30/2021) were classified into the ADHD cohort if they had ≥ 2 ADHD diagnoses (index date: first ADHD diagnosis) and into the non-ADHD cohort if they had no observed ADHD diagnosis (index date: random date) with a 1:3 case-to-control ratio.

Differences in eConsent among diagnosis groups.

eConsent is an electronic informed consent experience that contains videos, word flags, and knowledge checks, in addition to an electronic version of the informed consent document to enhance clinical trial participants' understanding of what they are consenting to. There are numerous perceived benefits of eConsent, however despite these benefits, adoption has remained low. eConsent data from 27 clinical trials was analyzed to gain insights and understand differences in the consenting process between diagnosis groups.

Effects of tolvaptan discontinuation in patients with autosomal dominant polycystic kidney disease: a post hoc pooled analysis.

Background: Tolvaptan slows kidney function decline in patients with autosomal dominant polycystic kidney disease (ADPKD) who are at risk of rapid progression. Given that treatment requires commitment to long-term use, we evaluated the effects of tolvaptan discontinuation on the trajectory of ADPKD progression.

Methods: This was a post hoc analysis of pooled data from two clinical trials of tolvaptan (TEMPO 2:4 [NCT00413777] and TEMPO 3:4 [NCT00428948]), an extension trial (TEMPO 4:4 [NCT01214421]), and an observational study (OVERTURE [NCT01430494]) that enrolled patients from the other trials.

Racial and Ethnic Disparities in Physical and Mental Health Care and Clinical Trials.

Historically, in the United States, scientific racism has been used to justify differential treatment of Black, Indigenous, People of Color (BIPOC) populations compared with the White population. Discrimination toward BIPOC populations by the medical community has contributed to racial and ethnic disparities in health care that persist to this day. At the 2022 American Society of Clinical Psychopharmacology Annual Meeting, a panel of 5 experts from the areas of academia, advocacy, and clinical research discussed racial and ethnic disparities in mental health care.

A Randomized, Open-Label, Multiple-Dose, Parallel-Arm, Pivotal Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole 2-Month Long-Acting Injectable in Adults With Schizophrenia or Bipolar I Disorder.

Background: Aripiprazole 2-month ready-to-use 960 mg (Ari 2MRTU 960) is a new long-acting injectable antipsychotic formulation for gluteal administration every 2 months, currently being investigated for the treatment of schizophrenia and bipolar I disorder (BP-I). The objectives of this trial were to evaluate the safety and tolerability of Ari 2MRTU 960, and the similarity of aripiprazole plasma concentrations following administration of Ari 2MRTU 960 or aripiprazole once-monthly 400 mg (AOM 400), in adults with schizophrenia or BP-I.

Methods: This was a 32-week open-label study.

Treatment Patterns Among Patients with Attention-Deficit/Hyperactivity Disorder and Comorbid Anxiety and/or Depression in the United States: A Retrospective Claims Analysis.

Introduction: Patients with attention-deficit/hyperactivity disorder (ADHD) often have psychiatric comorbidities that may confound diagnosis and affect treatment outcomes and costs. The current study described treatment patterns and healthcare costs among patients with ADHD and comorbid anxiety and/or depression in the United States (USA).

Methods: Patients with ADHD initiating pharmacological treatments were identified from IBM MarketScan Data (2014-2018).

Is Involved in Resistance to 7-Aminocholesterol and Secretion of Fungal Proteins in .

() is a pathogenic yeast that is the leading cause of fungal meningitis in immunocompromised patients. Various virulence factors, such as the enzyme laccase and its product melanin, phospholipase, and capsular polysaccharide have been identified. During a screen of knockout mutants, the gene resistance to aminocholesterol 1 () was identified, the function of which is currently unknown in .

Reasons for Treatment Changes in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Chart Review Study.

Introduction: This study aimed to examine the reasons underlying treatment changes among pediatric patients with attention-deficit/hyperactivity disorder (ADHD).

Methods: Data were obtained through online medical chart abstraction (08/2021-09/2021). Eligible patients with ADHD had initiated a treatment regimen at ages 6-17 and within 1-5 years of chart abstraction.

Identifying individuals with undiagnosed post-traumatic stress disorder in a large United States civilian population - a machine learning approach.

Background: The proportion of patients with post-traumatic stress disorder (PTSD) that remain undiagnosed may be substantial. Without an accurate diagnosis, these patients may lack PTSD-targeted treatments and experience adverse health outcomes. This study used a machine learning approach to identify and describe civilian patients likely to have undiagnosed PTSD in the US commercial population.

Treatment patterns among children and adolescents with attention-deficit/hyperactivity disorder in the United States - a retrospective claims analysis.

Background: Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral disorder affecting approximately 10.0% of children and 6.5% of adolescents in the United States (US).

Reasons for treatment changes in adults with attention-deficit/hyperactivity disorder: a chart review study.

Background: Adults with attention-deficit hyperactivity disorder (ADHD) often cycle through multiple treatments for reasons that are not well documented. This study analyzed the reasons underlying treatment changes among adults treated for ADHD in a real-world setting.

Methods: Data were collected via an online reporting form completed by eligible physicians between October and November 2020.

Effects of adjunctive brexpiprazole on calmness and life engagement in major depressive disorder: post hoc analysis of patient-reported outcomes from clinical trial exit interviews.

Background: Though often overlooked, calming patients and increasing their life engagement are key factors in the treatment of major depressive disorder (MDD). This study aimed to test the hypothesis that adjunctive brexpiprazole increases calmness and life engagement among patients with MDD, based on clinical trial exit interviews.

Methods: This was a pooled analysis of exit interview data from three exploratory, open-label studies of adjunctive brexpiprazole 1-3 mg/day.

Collaboration Between Child and Adolescent Psychiatrists and Mental Health Pharmacists to Improve Treatment Outcomes.

Access to mental health care is a long-standing challenge. The high, rising prevalence of mental health disorders and a shortage of mental health professionals has further strained an already fragile system. The clinical pharmacy is underutilized within the mental health space.

Increasing Efficiency and Cost-Effectiveness by Automating the Authoring of the Development Safety Update Report.

Introduction: A Development Safety Update Report (DSUR) is a comprehensive review of safety information collected during an annual reporting period for an investigational drug. The creation of a DSUR is a resource-intensive process, requiring effective communication among, and collaboration with, various functional stakeholders.

Objective: To increase the efficiency and cost-effectiveness of generating a DSUR with the use of an electronic authoring platform.

Using an Automated Algorithm to Identify Potential Drug-Induced Liver Injury Cases in a Pharmacovigilance Database.

Introduction: Drug-induced liver injury (DILI) is the most frequent cause of acute liver failure in North America and Europe, but it is often missed because of unstandardized diagnostic methods and criteria. This study aimed to develop and validate an automated algorithm to identify potential DILI cases in routine pharmacovigilance (PV) activities.

Methods: Post-marketing hepatic adverse events reported for a potentially hepatotoxic drug in a global PV database from 19 March 2017 to 18 June 2018 were assessed manually and with the automated algorithm.

Predictors and trajectories of treatment response to SSRIs in patients suffering from PTSD.

Paroxetine and sertraline are the only FDA approved drugs for treatment of posttraumatic stress disorder (PTSD). Although both drugs show better outcomes than placebo, not all patients benefit from treatment. We examined predictors and latent classes of SSRI treatment response in patients with PTSD.

Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials.

Causality assessment for suspected drug-induced liver injury (DILI) during drug development and following approval is challenging. The IQ DILI Causality Working Group (CWG), in collaboration with academic and regulatory subject matter experts (SMEs), developed this manuscript with the following objectives: (1) understand and describe current practices; (2) evaluate the utility of new tools/methods/practice guidelines; (3) propose a minimal data set needed to assess causality; (4) define best practices; and (5) promote a more structured and universal approach to DILI causality assessment for clinical development. To better understand current practices, the CWG performed a literature review, took a survey of member companies, and collaborated with SMEs.