BackgroundProlonged Grief Disorder (PGD) is a psychiatric diagnosis with significant implications for individuals and society. Familiarity with its diagnostic criteria and recommended interventions is essential for early detection and effective treatment. As aging naturally involves multiple losses, older adults are at distinct risk of developing PGD, a condition associated with psychological and physical comorbidities and increased mortality. In the Israeli context, this issue holds particular significance following the events of October 7, 2023, and the ensuing war, which have had — and continue to have — a profound impact on the population’s mental health. Given PGD’s recent inclusion in diagnostic manuals, many physicians may lack sufficient knowledge, leading to under-recognition or misdiagnosis. This gap is particularly evident among older adults, for whom the assessment and management of psychological distress are often underassessed and undertreated, highlighting the urgent need for targeted training and broader integration of existing knowledge into clinical practice. Accordingly, the present study has two main objectives: (1) to assess physicians’ knowledge and use of PGD diagnostic criteria with older patients, and (2) to evaluate the effectiveness of a brief informational intervention on their understanding and diagnostic application.MethodsUsing a mixed experimental design, the study will include senior physicians and residents specializing in geriatrics, psychiatry, and family medicine. Data will be collected via an online structured questionnaire containing professional background items and clinical vignettes designed to assess participants’ knowledge and application of PGD diagnostic criteria. Afterwards, participants will be individually randomized (1:1) via a computer-generated sequence in a partially participant-blinded, assessor-blinded controlled trial to either an experimental group viewing an informational PGD video or a control group viewing a structurally equivalent video (matched in length, graphics, and word count) addressing bereavement in older adults without directly referencing PGD. All participants will then complete the vignettes again to evaluate the effects of the intervention. A one-month follow-up assessment will evaluate the retention of intervention effects.DiscussionThis first systematic Israeli study on PGD implementation will provide an empirical basis for policy development, professional training, and prevention programs. Its findings may enhance diagnostic accuracy, improve care efficiency, reduce systemic costs, and support ongoing evaluation and refinement of clinical practices.Clinical trial registrationClinicalTrials.gov, identifier NCT07487233.
<![CDATA[Alkermes’ phase 2 Vibrance-2 shows alixorexton significantly boosts wakefulness and reduces daytime sleepiness in narcolepsy type 2, with benefits sustained.]]>
<![CDATA[Check out new phase 2 dose-ranging study data evaluating alixorexton in patients with narcolepsy type 2. ]]>
Single Dose Double-blind, Placebo-controlled Cross-over (SDDBPCCO) Shiftability Study, Will be Followed by a 10-week Open-label Study With Arbaclofen (4 Weeks of Titration and Then 6 Weeks of Active/Stable Treatment). The Effects of Arbaclofen on Target EEG and ERG Metrics Will be Associated With th
Conditions: Autism Spectrum Disorders
Interventions: Drug: Arbaclofen; Other: Placebo
Sponsors: Hospital General Universitario Gregorio Marañon; Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
Recruiting
Interventions: Drug: Arbaclofen; Other: Placebo
Sponsors: Hospital General Universitario Gregorio Marañon; Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
Recruiting
STAT+: How a biotech turned a trial failure into an AI model
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Think anyone will notice if I sneak out to go to a parade in New York on Thursday?
STAT+: Verge Labs’ new AI model solves patient stratification problems for neurology clinical trials
As the saying goes, one man’s trash is another man’s treasure. Or as Verge Labs might put it, one company’s failed clinical trial … is that same company’s new AI benchmarking dataset.
Over a decade ago, Alice Zhang co-founded Verge Genomics with the idea that by looking at the network of genes causing neurodegenerative diseases like Parkinson’s, ALS, or Alzheimer’s, the company would be able to come up with better drugs. The company did target discovery work, for example, coming up with two targets that Eli Lilly nominated to its internal pipeline in 2024. Verge also had its own pipeline, where it was pursuing an ALS drug — that is, until its Phase 1b trial failed last month.
The company published a postmortem explaining what exactly went wrong with the trial, in which a third of the patients dropped out because they could not tolerate the drug. “While the temptation is strong, when a trial doesn’t meet the anticipated end points, to kind of look away and not talk about it, we think there are a lot of learnings that can come — not just for us, but for the field and for ALS broadly — that’s really important to share. That’s not done very often,” Zhang told STAT in an interview.
Examining the Efficacy of a Telehealth-Based Virtual Reality Clinic in Treating Adults With Specific Phobia: Feasibility Randomized Controlled Trial
Background: Virtual reality (VR) has the potential to enhance telemental health care (TMH) by enabling accessible, engaging, and personalized treatment from home. Although VR is well-supported for in-person treatment, evidence for telehealth-based VR is limited. Moreover, no prior research has demonstrated the feasibility of therapists and clients conducting therapy sessions remotely within a shared (ie, multiuser) VR experience. Objective: The primary objective of this study was to evaluate the feasibility of conducting a randomized controlled efficacy trial (RCT) comparing exposure therapy delivered via Doxy.me VR (Doxy.me Inc)—a multiuser, telehealth-based VR app—to standard TMH in adults with clinically elevated fear of dogs, snakes, or spiders. A secondary objective was to preliminarily examine clinical (ie, specific phobia symptom severity) and treatment-related outcomes (ie, therapeutic alliance, client satisfaction, system usability, presence, cybersickness, and treatment fidelity). Methods: This study used a single-site, fully remote, parallel, feasibility RCT design. Participants were randomly assigned using a 1:1 ratio to receive 12 weekly exposure therapy sessions over 3 months, delivered via either standard TMH or Doxy.me VR. Assessments were conducted at baseline, each session, midtreatment, and posttreatment. All therapy sessions were audio recorded, 20% of which were randomly selected and rated for treatment fidelity. Feasibility benchmarks during the 12-month trial included: (1) enrolling 30 participants during Months 1‐9 of the trial; (2) collecting 70% of midtreatment self-report data; (3) collecting 70% of posttreatment self-report data; (4) collecting 70% of weekly self-report data; and (5) achieving treatment fidelity ≥80%. Between-group differences in clinical treatment-related outcomes also were examined preliminarily. Results: A total of 54 participants were enrolled between October 25, 2023 and July 26, 2024, and randomly assigned to the Doxy.me VR (n=29) and TMH (n=25) conditions, exceeding our recruitment target by 180%. Among the 30 participants targeted for completion, data were obtained from 29 (96.7%) at midtreatment and 28 (93.3%) at posttreatment. Participants completed 86.5% (180/208) of weekly self-report assessments. Treatment fidelity was 90% based on ratings of 41 session recordings. There were no significant between-group differences in clinical outcomes (all >.05) or most treatment-related outcomes. However, client satisfaction improved significantly more for the Doxy.me VR condition compared to TMH (=.04). Power analyses indicated that a sample of 160 participants would ensure adequate power for a fully powered trial. Conclusions: Telehealth-based, multiuser, synchronous VRET is feasible and shows preliminary evidence of efficacy. These findings are promising, and opportunities to improve procedures identified in this feasibility trial will directly inform the protocol for a fully powered RCT evaluating telehealth-based VR and its potential to improve treatment of mental health disorders. Trial Registration: ClinicalTrials.gov NCT06302868; https://clinicaltrials.gov/study/NCT06302868 International Registered Report Identifier (IRRID): RR2-10.2196/65770
STAT+: A key European clinical trial registry lacks complete and timely results, an analysis finds
Amid ongoing concern about clinical trial transparency, a new analysis found that results for less than half of the studies registered in a key European database were reported within the required time frame and complete results were fully reported for only 42%.
While the quality of the registration data was high overall — more than 99% of expected data was found in the 234 clinical trials for which results were supposed to have been disclosed — the researchers contended that overall compliance with legal reporting requirements was weak and regulatory oversight is lacking.
European Union and member state regulators “have so far not delivered the promised ‘high levels of transparency never seen before for clinical trials,’” the authors wrote in their analysis. It was recently posted on the medRxiv preprint server, which displays unpublished research that has not yet been peer reviewed.
Efficacy and target engagement of dopamine agonist pramipexole for anhedonic depression: a randomized placebo-controlled trial
Nature Medicine, Published online: 12 June 2026; doi:10.1038/s41591-026-04465-9
Pramipexole, in patients with major depressive disorder, dysthymia or bipolar depression, reduced Snaith−Hamilton Pleasure Scale scores significantly compared to placebo.
Remote Monitoring Benefits Unclear After Hospitalization for Serious Infection
Remotely monitoring patients after they have been released from the hospital for serious infections does not reduce their risk of readmission, particularly for older adults, a randomized trial suggests.
The findings, released simultaneously in JAMA Network Open and at the Critical Care Reviews annual meeting in Belfast, emphasize the importance of studying potentially beneficial care models in real-world scenarios.
Remote monitoring involves the use of resources such as smartphone-based questionnaires, internet-connected scales, or blood pressure monitoring to allow patients to leave hospital.
These enable clinicians to monitor health from afar, while acting on alerts to ensure timely care.
While patients might prefer this type of care, the trial suggested that remote monitoring should be re-evaluated and individually tailored after acute care for sepsis and lower respiratory tract infections.
It did not increase the days patients spent at home and did not support U.S. federal agency efforts to reduce hospital readmissions by reimbursing remote monitoring.
“Health systems, insurers and policymakers all want to reduce hospital readmissions, and most patients prefer to recover safely at home,” explained lead researcher Sachin Yende, PhD, from the University of Pittsburgh.
“Remote monitoring has been held up as a solution, is reimbursed by the Centers of Medicare & Medicaid and its use has grown. But, aside from a few conditions, there’s a dearth of high-quality data to show it reduces readmissions.”
In an attempt to source this information, Yende and team conducted a complex trial in 1286 adults, with a median age of 63 years, who were recovering at home after hospitalization for sepsis or lower respiratory tract infections at 19 institutions. Of these patients, 32.6% received intensive care.
Participants were randomly assigned to one of four remote monitoring strategies or usual care.
Usual care generally involved a phone call from a nurse after discharge followed by continuing management from a primary care physician. The remote monitoring interventions consisted of short or long health questionnaire with standard or enhanced clinical response teams.
The standard response involved nurses who responded to alerts highlighted in the questionnaires together with coordinated care involving the patient’s primary and specialty clinicians.
Enhanced care included certified registered nurse practitioners with palliative care expertise who could coordinate some of the care response and also access social workers.
The primary endpoint was days at home at 90 days after discharge.
The trial showed that remote monitoring programs with high- or low-intensity questionnaires combined with a nurse response team or a nurse practitioner-led response team did not increase the time spent at home.
At least one readmission occurred among 37.8% of patients in the control group, receiving usual care.
This compared with 39.7% in patients receiving the shorter questionnaire and standard response team, 44.2% for those receiving the long questionnaire with standard clinical response, 37.3% receiving the shorter questionnaire but enhanced response team, and 36.3% for those receiving the long questionnaire with enhanced clinical response.
These differences did not reach statistical significance.
However, among patients aged 65 years and older, the remote monitoring programs did reduced time spent at home and increased readmission rates compared with usual care.
In this older age group, both the standard and enhanced response groups had fewer home days compared with usual care, with corresponding cumulative odds ratios of 0.56 and 0.67.
“These findings support reevaluating and tailoring remote monitoring in post–acute care following sepsis and lower respiratory tract infection to support further alignment with patients’ needs and desire for personalized monitoring,” the researchers concluded.
The post Remote Monitoring Benefits Unclear After Hospitalization for Serious Infection appeared first on Inside Precision Medicine.