[Posted 23/Oct/2024]

AUDIENCE: Psychiatry, Family Medicine

KEY FINDINGS: The study reveals that the SIS can predict status anxiety. The SIS can contribute to research regarding important phenomena such as the detrimental psychological effects of income inequality.

BACKGROUND: Although substantial research indicates that considerations about status can lead to anxiety and other negative outcomes, a valid measure of the importance individuals attribute to status is lacking.

DETAILS: The study introduces the Status Importance Scale (SIS), a mono-factorial 10-item self-report questionnaire that quantifies how important a person deems status to be. Five studies validate the scale showing that it has excellent internal reliability and acceptable test–retest reliability, it correlates with several related measures (supporting convergent validity), it shows little correlation with theoretically unrelated constructs (supporting discriminant validity), it is the best predictor of conspicuous consumption compared with other potential candidates (supporting concurrent validity), and it can help predicting which activities one gives importance to (further supporting concurrent validity).

Copyright © The British Psychological Society. All rights reserved.

Source: Rigoli, F. and Mirolli, M. (2024). The Status Importance Scale: Development and Validation of a Self-Report Questionnaire for Measuring How Much People Care About Status. British Journal of Psychology. 2024; 115(4): 683-705. Published: November, 2024. DOI: 10.1111/bjop.12716.

A Phase 3 Randomized Clinical Trial

[Posted 11/Mar/2025]

AUDIENCE: Psychiatry, Family Medicine, Nursing

KEY FINDINGS: Results of this randomized clinical trial show that brexpiprazole + sertraline combination treatment statistically significantly improved PTSD symptoms vs sertraline + placebo, indicating its potential as a new efficacious treatment for PTSD. Brexpiprazole + sertraline was tolerated by most participants, with a safety profile consistent with that of brexpiprazole in approved indications.

BACKGROUND: New pharmacotherapy options are needed for posttraumatic stress disorder (PTSD). Purpose of this study is to investigate the efficacy, safety, and tolerability of brexpiprazole and sertraline combination treatment (brexpiprazole + sertraline) compared with sertraline + placebo for PTSD.

DETAILS: This was a parallel-design, double-blind, randomized clinical trial conducted from October 2019 to August 2023. The study had a 1-week, placebo run-in period followed by an 11-week, double-blind, randomized, active-controlled, parallel-arm period (with 21-day follow-up) and took place at 86 clinical trial sites in the US. Adult outpatients with PTSD were enrolled (volunteer sample). The primary end point was change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score (which measures the severity of 20 PTSD symptoms) from randomization (week 1) to week 10 for brexpiprazole + sertraline vs sertraline + placebo. Safety assessments included adverse events. A total of 1327 individuals were assessed for eligibility. After 878 screen failures, 416 participants (mean [SD] age, 37.4 [11.9] years; 310 female [74.5%]) were randomized. Completion rates were 137 of 214 participants (64.0%) for brexpiprazole + sertraline and 113 of 202 participants (55.9%) for sertraline + placebo. At week 10, brexpiprazole + sertraline demonstrated statistically significant greater improvement in CAPS-5 total score (mean [SD] at randomization, 38.4 [7.2]; LS mean [SE] change, -19.2 [1.2]; n = 148) than sertraline + placebo (randomization, 38.7 [7.8]; change, -13.6 [1.2]; n = 134), with LS mean difference, -5.59 (95% CI, -8.79 to -2.38; P .001). All key secondary and other efficacy end points were also met. Treatment-emergent adverse events with incidence of 5% or greater for brexpiprazole + sertraline (and corresponding incidences for sertraline + placebo) were nausea (25 of 205 [12.2%] and 23 of 196 [11.7%]), fatigue (14 of 205 [6.8%] and 8 of 196 [4.1%]), weight increase (12 of 205 [5.9%] and 3 of 196 [1.5%]), and somnolence (11 of 205 [5.4%] and 5 of 196 [2.6%]). Discontinuation rates due to adverse events were 8 of 205 participants (3.9%) for brexpiprazole + sertraline and 20 of 196 participants (10.2%) for sertraline + placebo.

Copyright © American Medical Association. All Rights Reserved.

Source: Davis, L. L., Behl, S., Lee, D., et al. (2024). Brexpiprazole and Sertraline Combination Treatment in Posttraumatic Stress Disorder: A Phase 3 Randomized Clinical Trial. JAMA Psychiatry. 2025; 82(3): 218-227. Published: March, 2025. DOI: 10.1001/jamapsychiatry.2024.3996.

The YAWNS NB Randomized Clinical Trial

[Posted 30/Dec/2024]

AUDIENCE: Psychiatry, Family Medicine

KEY FINDINGS: Results of the YAWNS NB randomized clinical trial show that, as a simple, scalable, direct-to-patient intervention, YAWNS-1 substantially reduced BZRA use and improved sleep outcomes. It could be implemented to transform insomnia care for older adults at the population level.

BACKGROUND: Direct-to-patient interventions enabling transitions from long-term benzodiazepine receptor agonist (BZRA) use to cognitive behavioral therapy for insomnia (CBTI) by older adults has the potential to reduce BZRA use and related harms while improving sleep outcomes without requiring prearranged clinician involvement. Aim of this study was to compare 2 direct-to-patient behavior change interventions with treatment as usual (TAU) on BZRA use, sleep, and other health outcomes, and uptake of CBTI techniques.

DETAILS: The Your Answers When Needing Sleep in New Brunswick (YAWNS NB) study was a 3-arm, pragmatic, open-label, minimum-contact, randomized clinical trial. The study began November 2020 and ended June 2022. Participants were randomly allocated to 1 of 3 groups, including 2 different mailed behavior change interventions or no intervention (TAU). Participants were from communities across the province of New Brunswick, Canada, and included adults 65 years and older living independently with long-term use of BZRAs and current or past insomnia. The Sleepwell package (YAWNS-1) consisted of a cover letter and 2 booklets (“How to Stop Sleeping Pills” and “How to Get Your Sleep Back”). The other package (YAWNS-2) included updated versions of the 2 booklets (“You May Be at Risk” and “How to Get a Good Night’s Sleep Without Medication”) used in the Eliminating Medications Through Patient Ownership of End Results (EMPOWER) study. Main outcomes and measures: BZRA use at 6 months was the primary measure. Secondary measures included CBTI use, sleep, insomnia, daytime sleepiness, safety, anxiety, frailty, and quality of life.

A total of 1295 individuals expressed interest in the study, and 565 (43.6%) completed a baseline assessment. Participants had a mean (SD) age of 72.1 (5.7) years, a mean (SD) BZRA use duration of 11.4 (9.1) years, and 362 (64.1%) were female. Discontinuations and dose reductions of 25% or greater were highest with YAWNS-1 (50 of 191 [26.2%]; 39 of 191 [20.4%]; total, 46.6%) compared with YAWNS-2 (38 of 187 [20.3%]; 27 of 187 [14.4%]; total, 34.8%, P = .02) and TAU (14 of 187 [7.5%]; 24 of 187 [12.8%]; total, 20.3%, P < .001). YAWNS-1 also demonstrated better uptake of CBTI techniques and sleep outcomes compared with YAWNS-2 (new CBTI techniques: 3.1 vs 2.4; P =.03; sleep efficiency change: 4.1% vs -1.7%; P =.001) and reduced insomnia severity and daytime sleepiness compared with TAU (insomnia severity index change: -2.0 vs 0.3; P <.001; Epworth Sleepiness Scale change: -0.8 vs 0.3; P =.001).

Copyright © American Medical Association. All Rights Reserved.

Source: Gardner, D. M., Turner, J. P., Magalhaes, S., et al. (2024). Patient Self-Guided Interventions to Reduce Sedative Use and Improve Sleep: The YAWNS NB Randomized Clinical Trial. JAMA Psychiatry. 2024; 81(12): 1187-1197. Published: December, 2024. DOI: 10.1001/jamapsychiatry.2024.2731.

A Randomized Clinical Trial

[Posted 26/Aug/2024]

AUDIENCE: Psychiatry, Family Medicine

KEY FINDINGS: Xanomeline-trospium was efficacious and well tolerated in people with schizophrenia experiencing acute psychosis. These findings, together with the previously reported and consistent results from the EMERGENT-1 and EMERGENT-2 trials, support the potential of xanomeline-trospium to be the first in a putative new class of antipsychotic medications without D2 dopamine receptor blocking activity.

BACKGROUND: A significant need exists for new antipsychotic medications with different mechanisms of action, greater efficacy, and better tolerability than existing agents. Xanomeline is a dual M1/M4 preferring muscarinic receptor agonist with no direct D2 dopamine receptor blocking activity. KarXT combines xanomeline with the peripheral muscarinic receptor antagonist trospium chloride with the goal of reducing adverse events due to xanomeline-related peripheral muscarinic receptor activation. In prior trials, xanomeline-trospium chloride was effective in reducing symptoms of psychosis and generally well tolerated in people with schizophrenia. Purpose of this study is to evaluate the efficacy and safety of xanomeline-trospium vs placebo in adults with schizophrenia.

DETAILS: EMERGENT-3 (NCT04738123) was a phase 3, multicenter, randomized, double-blind, placebo-controlled, 5-week trial of xanomeline-trospium in people with schizophrenia experiencing acute psychosis, conducted between April 1, 2021, and December 7, 2022, at 30 inpatient sites in the US and Ukraine. Data were analyzed from February to June 2023. Participants were randomized 1:1 to receive xanomeline-trospium chloride (maximum dose xanomeline 125 mg/trospium 30 mg) or placebo for 5 weeks. The prespecified primary end point was change from baseline to week 5 in Positive and Negative Syndrome Scale (PANSS) total score. Secondary outcome measures were change from baseline to week 5 in PANSS positive subscale score, PANSS negative subscale score, PANSS Marder negative factor score, Clinical Global Impression-Severity score, and proportion of participants with at least a 30% reduction in PANSS total score. Safety and tolerability were also evaluated. A total of 256 participants (mean [SD] age, 43.1 [11.8] years; 191 men [74.6%]; 156 of 256 participants [60.9%] were Black or African American, 98 [38.3%] were White, and 1 [0.4%] was Asian) were randomized (125 in xanomeline-trospium group and 131 in placebo group). At week 5, xanomeline-trospium significantly reduced PANSS total score compared with placebo (xanomeline-trospium , -20.6; placebo, -12.2; least squares mean difference, -8.4; 95% CI, -12.4 to -4.3; P < .001; Cohen d effect size, 0.60). Discontinuation rates due to treatment-emergent adverse events (TEAEs) were similar between the xanomeline-trospium (8 participants [6.4%]) and placebo (7 participants [5.5%]) groups. The most common TEAEs in the xanomeline-trospium vs placebo group were nausea (24 participants [19.2%] vs 2 participants [1.6%]), dyspepsia (20 participants [16.0%] vs 2 participants [1.6%]), vomiting (20 participants [16.0%] vs 1 participant [0.8%]), and constipation (16 participants [12.8%] vs 5 participants [3.9%]). Measures of extrapyramidal symptoms, weight gain, and somnolence were similar between treatment groups.

Copyright © American Medical Association. All Rights Reserved.

Source: Kaul, I., Sawchak, S., Walling, D. P., et al. (2024). Efficacy and Safety of Xanomeline-Trospium Chloride in Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2024; 81(8): 749-756. Published: August, 2024. DOI: 10.1001/jamapsychiatry.2024.0785.

A Stage 2 Registered Report

[Posted 7/Aug/2024]

AUDIENCE: Psychiatry, Family Medicine

KEY FINDINGS: The results indicated AVGs showed superior spatial working memory and complex attention abilities while showing no difference from NGs on simple attention performance. Additionally, authors found that our cognitive fatigue and control interventions did not differentially affect the cognitive performance of AVGs and NGs in this study. This pre-registered study provides evidence that AVGs show superior cognitive abilities in comparison to a non-gaming population, but do not appear more resilient to cognitive fatigue.

BACKGROUND:

DETAILS: Recent work demonstrates that those who regularly play action video games (AVGs) consistently outperform non-gamer (NG) controls on tests of various cognitive abilities. AVGs place high demands on several cognitive functions and are often engaged with for long periods of time (e.g., over 2 h), predisposing players to experiencing cognitive fatigue. The detrimental effects of cognitive fatigue have been widely studied in various contexts where accurate performance is crucial, including aviation, military, and sport. Even though AVG players may be prone to experiencing cognitive fatigue, this topic has received little research attention to date. In this study, authors compared the effect of a cognitively fatiguing task on the subsequent cognitive performance of action video game players and NG control participants.

Copyright © The British Psychological Society. All rights reserved.

Source: Campbell, M. J., Cregan, S. C., Joyce, J. M., et al. (2024). Comparing the Cognitive Performance of Action Video Game Players and Age-Matched Controls Following a Cognitively Fatiguing Task: A Stage 2 Registered Report. Br. J. Psychol. 2024; 115(3): 363-385. Published: August, 2024. DOI: 10.1111/bjop.12692.

A Systematic Review With Meta-Regression Analyses

[Posted 3/Jun/2024]

AUDIENCE: Psychiatry, Ob/gyn

KEY FINDINGS: Prison services worldwide, and particularly in Europe, should prioritise suicide prevention. Assessment and management of suicide risk in female individuals living in prison need particular attention due to excess mortality relative to community-based populations. Interpretation of synthesised data needs to be done with caution due to high heterogeneity between jurisdictions.

BACKGROUND: Suicide is a leading cause of death during imprisonment. This systematic review aimed to synthesise available evidence of prison suicide incidence worldwide.

DETAILS: Authors systematically searched the scientific literature, data repositories, and prison system reports, supplemented by correspondence with prison administrations. Authors included reports on people living in prison but excluded studies in preselected groups (by age or offence type). Absolute numbers and incidence rates of suicide mortality per 100,000 person-years by sex and country were extracted from 2000 to 2021. IQRs were used to describe the suicide incidence in different world regions. Incidence rate ratios comparing suicides of people living in prison with age-standardised general populations were calculated. Authors conducted meta-regression analyses on national-level and prison-level factors to examine heterogeneity. Authors included three scientific studies, 124 official reports, and 11 datasets from email correspondence. Between 2000 and 2021, there were 29,711 reported suicides during 91.2 million person-years of imprisonment in 82 jurisdictions worldwide (sex-specific data available for 13,289 individuals: 12,544 [94.4%] male and 745 [5.6%] female individuals). There were large variations between countries, with most studies reporting suicide rates in the range of 24-89 per 100,000 person-years in both sexes (22-86 in male individuals and 25-107 in female individuals). In meta-regression analyses, Europe (vs other regions), high-income countries (vs low-income and middle-income countries), and countries with lower incarceration rates (vs those with higher incarceration rates) had higher suicide rates. Incidence rate ratios between people who are incarcerated and age-standardised general populations in the same jurisdictions were typically in the range of 1.9-6.0 in male and 10.4-32.4 in female individuals.

Copyright © Elsevier Ltd. All rights reserved.

Source: Mundt, A. P., Cifuentes-Gramajo, P. A., Baranyi, G. et al. (2024). Worldwide Incidence of Suicides in Prison: A Systematic Review With Meta-Regression Analyses. The Lancet. 2024; Published: May 29, 2024. DOI: 10.1016/S2215-0366(24)00134-2.