<![CDATA[Phase 3 at-home data show sublingual dexmedetomidine cuts severe agitation in bipolar disorder and schizophrenia, supporting FDA label expansion.]]>
Clinical Trial of an IL-23 Inhibitor for Immune Activation in Clinical Trial of an IL-23 Inhibitor for Immune Activation in People With Schizophrenia
Conditions: Schizophrenia; Schizo Affective Disorder; Healthy
Interventions: Drug: Placebo; Drug: IL-23
Sponsors: University of Maryland, Baltimore
Not yet recruiting
Interventions: Drug: Placebo; Drug: IL-23
Sponsors: University of Maryland, Baltimore
Not yet recruiting
<![CDATA[Phase 2b data show DT‑120, optimized oral LSD, delivers durable GAD remission with mostly same‑day side effects; phase 3 trials advance.]]>
<![CDATA[Phase 3 data show COMP360 psilocybin rapidly lifts treatment-resistant depression, with durable MADRS gains and stronger effects from two sessions.]]>
Non-invasive electrical stimulation for sleep disturbances in adults: protocol for an evidence−mapping umbrella review of systematic reviews and meta−analyses with subgroup analysis by intervention type and population
BackgroundSleep disturbances affect 10%–30% of adults worldwide. Non−invasive electrical stimulation (e.g., transcranial electrical stimulation) has emerged as a promising non−pharmacological intervention. Although numerous systematic reviews and meta−analyses have been published, they vary considerably in methodological quality, populations, intervention types, and conclusions. No umbrella review has yet synthesised the evidence across different modalities and populations. This evidence mapping umbrella review aims to systematically chart the existing systematic reviews, assess methodological quality, quantify overlap, and describe evidence patterns across diverse modalities and populations.MethodsFollowing JBI guidelines, we will search PubMed, Embase, Cochrane Database of Systematic Reviews, Web of Science, PsycINFO, and Scopus (inception to April 2026), restricted to English. Grey literature will be searched via PROSPERO, ClinicalTrials.gov, Google Scholar (first 200 records), and reference list screening (snowballing). We will include systematic reviews and meta−analyses of randomised controlled trials evaluating any non−invasive electrical stimulation for sleep outcomes. Two reviewers will independently screen, extract data, and assess methodological quality using AMSTAR 2. Primary study overlap will be quantified by the Corrected Covered Area. Where feasible, we will calculate 95% prediction intervals, perform Egger’s regression tests, and conduct excess significance tests using review-level summary estimates. Subgroup analyses will be stratified by intervention and population type. Sensitivity analyses will exclude: (1) reviews with critically low AMSTAR 2 ratings, (2) preprints, (3) reviews at high risk of reporting bias, and (4) studies where sleep is not the primary outcome. The primary outcome is subjective sleep quality; total sleep time is a key secondary outcome. Evidence will be graded using the Fusar−Poli classification, with GRADE for key outcomes.DiscussionThis umbrella review will provide the highest level of evidence synthesis, identifying modalities with more consistent or higher certainty evidence and highlighting areas where evidence remains uncertain. Limitations include restriction to English (which may disproportionately impact modalities such as TEAS), expected heterogeneity, and possible insufficient data for some subgroup analyses. All amendments have been documented in PROSPERO (CRD420261357590).Clinical Trial Registrationhttps://www.crd.york.ac.uk/prospero/, identifier CRD420261357590.
STAT+: Experimental hepatitis B treatment was a ‘functional cure’ for nearly 1 in 5, new data show
An experimental medicine helped vanquish hepatitis B in clinical trials in nearly 1 in 5 people with chronic infections caused by the virus, far outperforming available treatment options in an illness that kills 1 million people every year.
Some 250 million to 300 million people globally have chronic hepatitis B infections, which can cause serious issues including cirrhosis and liver cancer. Current treatments, known as nucleoside analogues, lead to so-called functional cures in only 1% to 3% of patients.
But in a pair of Phase 3 trials, GSK’s bepirovirsen, or “bepi,” helped 20% and 19% of patients achieve functional cures, with no patients on placebo reaching that point, according to data released Thursday.
A Randomised Waitlist Controlled Clinical Trial of the Restory Treatment Program
Conditions: PTSD – Post Traumatic Stress Disorder; Sexual Abuse
Interventions: Behavioral: Restory
Sponsors: Karolinska Institutet; Göteborg University; Linkoeping University
Recruiting
Interventions: Behavioral: Restory
Sponsors: Karolinska Institutet; Göteborg University; Linkoeping University
Recruiting
Fibroblast growth factor receptor inhibition for succinate dehydrogenase-deficient gastrointestinal stromal tumors: a phase 2 trial
Nature Medicine, Published online: 26 May 2026; doi:10.1038/s41591-026-04376-9
In a multicenter phase 2 trial, the fibroblast growth factor receptor inhibitor rogaratinib showed encouraging clinical efficacy in patients with succinate dehydrogenase-deficient gastrointestinal stromal tumors, suggesting a potential new treatment option for this patient population and demonstrating that an epigenetic mechanism of oncogene activation can be successfully targeted with a tyrosine kinase inhibitor.
Testing a Smartphone-Based Intervention Targeting Anxiety Sensitivity Among Women Presenting for Emergency Care After Sexual Assault: Pilot Randomized Controlled Trial
Background: Anxiety sensitivity (AS), defined as the fear of anxious arousal, is a promising therapeutic target for reducing posttraumatic stress disorder (PTSD) symptom development after trauma exposure. Initial research suggests that smartphone-based AS interventions may be acceptable to sexual assault survivors at risk for PTSD symptoms and effective for symptom reduction, but only small one-arm proof-of-concept studies have been conducted. Objective: The goal of this study was to extend prior proof-of-concept work by conducting a pilot randomized controlled trial. The aims were to evaluate intervention efficacy, AS and PTSD symptom change, the acceptability and credibility of a control intervention, and the feasibility of a larger randomized controlled trial. Methods: A total of 60 women with high AS presenting for emergency care after sexual assault were recruited and randomized to either the AS intervention or a control condition, and they were followed up with for over 6 months via remote self-report questionnaires. Results: The findings indicated that the study population is at risk and in need of intervention: 88.8% (40/45) and 80.6% (29/36) of women sexual assault survivors in the sample met the criteria for probable PTSD at 7 weeks and 6 months post assault, respectively. Most (16/27, 59.3%) individuals receiving the AS intervention who completed it rated it as acceptable (eg, 18/21, 85.7% reported that the treatment was helpful). Early within-group reductions were not statistically significant, but by month 6, statistically significant reductions in AS and PTSD symptoms were observed in both conditions. Recruitment and retention data supported the feasibility of the study design, although some suggestions were noted for future research (eg, improving intervention and ecological momentary assessment compliance). Conclusions: This pilot study replicated the proof of concept and acceptability of a novel smartphone-based intervention targeting AS delivered to women sexual assault survivors presenting to emergency care. Intervention completion was in line with or better than traditional therapy but remained a challenge. Our selected control condition demonstrated a larger effect than expected, and we were unable to track its initiation or completion, causing difficulty in drawing conclusions. Overall, the results highlight the need for additional research. Trial Registration: ClinicalTrials.gov NCT05305235; https://clinicaltrials.gov/ct2/show/NCT05305235
<img src="https://jmir-production.s3.us-east-2.amazonaws.com/thumbs/492053ca2749db9a1e293caa4733770d" />
STAT+: Eli Lilly says Verve’s gene editor lowers cholesterol levels in early study
Eli Lilly said Monday that a high dose of its gene-editing therapy reduced cholesterol levels by 62% in participants in a clinical trial, an early but encouraging test of whether a one-time treatment may one day help people seeking to lower their LDL, or “bad,” cholesterol.
Lilly acquired the therapy, VERVE-102, in its $1 billion buyout of Verve Therapeutics last year. Executives tout it as a potential treatment to broadly prevent heart disease, the world’s leading killer, as many patients struggle to stay on existing, more conventional medicines for reducing cholesterol levels.
There were no treatment-related serious adverse events in the Phase 1 study — a notable finding, given that Verve had to shelve its first candidate due to safety concerns.