Randomized,double-blind trial evaluating the efficacy and safety of fluticasone propionate and fluticasone propionate/salmeterol delivered via multidose dry powder inhalers in patients with persistent asthma aged 12 years and older

Objective: To assess the efficacy and safety of fluticasone propionate (Fp) and Fp/salmeterol (FS) administered via a novel multidose dry powder inhaler (MDPI) that is easy to use correctly in asthma patients. Methods: This phase-3, multicenter, double-blind, parallel-group study evaluated asthmatic patients (≥12 years of age) previously treated with either low- or mid-dose inhaled corticosteroids (ICSs) or ICS/long-acting beta agonists. After a 14- to 21-day run-in, patients were randomized to Fp MDPI 50 mcg, Fp MDPI 100 mcg, FS MDPI 50/12.5 mcg, FS MDPI 100/12.5 mcg, or placebo twice daily for 12 weeks. Change from baseline in forced expiratory volume in 1 second (FEV₁; primary endpoint) was evaluated at week 12, and serial spirometry was collected at day 1 and week 12 (subset of patients). Safety was assessed by adverse events (AEs). Results: The full analysis and serial spirometry subset included 640 and 312 patients, respectively. At week 12, FS MDPI significantly improved FEV₁ from baseline at each dose vs corresponding Fp MDPI doses (p < 0.05). Change from baseline in FEV₁ for active treatment groups was significantly greater vs placebo (p < 0.05). After 12 weeks, serial spirometry was significantly greater at all time points in the FS MDPI groups vs corresponding Fp MDPI groups (p < 0.05). Improvements in serial spirometry on day 1 were maintained through week 12. AEs were similar across groups. Conclusions: Pulmonary function was significantly improved with Fp MDPI and FS MDPI vs placebo and FS MDPI vs Fp MDPI. Active treatments had a safety profile comparable to placebo.     

Non-Suicidal Self-Injury,Sexuality Concerns,and Emotion Regulation among Sexually Diverse Adolescents: A Multiple Mediation Analysis

Despite increasing interest in the prevalence and correlates of Non-Suicidal Self-Injury (NSSI) in adolescent populations, relatively few studies have examined NSSI among lesbian, gay and bisexual (LGB) adolescents. The current study explored sexuality concerns and elevated emotion dysregulation as potential mechanisms underlying the relationship between sexual orientation and elevated non-suicidal self-injury (NSSI). A community sample of 1,799 adolescents completed a questionnaire assessing NSSI, sexual orientation, sexuality concerns, and emotion regulation. Across the study, 20.6% of adolescents reported a history of NSSI. Adolescents who identify as “mostly heterosexual,” “bisexual,” and “mostly homosexual” were more likely to engage in NSSI than gay/lesbian, heterosexual, and asexual adolescents. Multiple mediation analysis showed that emotion regulation, but not sexuality concerns, mediated the relationship between sexual orientation and NSSI. The current study tested two theoretical pathways by which sexual orientation could predict NSSI engagement. Findings suggest that literature on general psychological processes, as well as group-specific minority stressors, can shed light on high rates of NSSI among LGB populations. Specifically, the challenges faced by LGB adolescents may undermine the development of emotion regulation. As such, this should be a key target of intervention with LGB adolescents engaging in NSSI.     

Prevalence of psychopathology in bipolar high-risk offspring and siblings: a meta-analysis

This meta-analysis aimed to update existing data on the comparison of prevalence rates of psychopathology primarily among offspring with at least one parent with bipolar disorder (BD) and offspring of parents without psychiatric illness. Seventeen studies were derived from a systematic search of PsychInfo, Medline, Scopus and Embase. Inclusion criteria were use of a control offspring group, standardized diagnostic procedures and reporting of clear frequency data. Risk of psychopathology was estimated by aggregating frequency data from selected studies. Compared to control offspring, high-risk BD offspring are nine times more likely to have a bipolar-type disorder, almost two and a half times more likely to develop a non-BD affective disorder and over two times more likely to develop at least one anxiety disorder. High-risk offspring also showed a significant increased risk of other non-mood psychopathology such as attention deficit hyperactivity disorder (ADHD), any type of behavioral disorder and substance use disorder (SUDs). Risk of developing a broad range of affective and non-affective psychopathology is significantly higher in high-risk BD offspring. Identifying clinical presentations of this genetically high-risk cohort is important in establishing appropriate preventative treatment.