Esketamine Monotherapy Safe, Effective for TRD: Phase 4 Data
Esketamine monotherapy was associated with significantly alleviated symptoms of treatment-resistant depression (TRD) at day 28 compared to placebo in a new phase 4 trial. The research extends findings from an earlier trial that served as the basis for the January FDA approval of an expanded indication for esketamine alone in patients with TRD.
METHODOLOGY:
The phase 4, double-blind, placebo-controlled, randomized clinical trial was conducted from 2020 to 2024 at 51 outpatient centers in the US.
Adults with major depressive disorder (mean age, 45.4 years; 61% women) with inadequate response to two or more oral antidepressants during the current depressive episode were included.
After an antidepressant-free period of 2 or more weeks, participants were randomly assigned to receive intranasal esketamine monotherapy 56 mg (n = 86) or 84 mg (n = 95) or matching placebo (n = 197) twice weekly for 4 weeks.
The primary outcome was a change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to day 28. Other outcomes included change in MADRS score at 24 hours post-first dose, rates of response and remission, and occurrence of adverse events.
TAKEAWAY:
Compared with placebo, esketamine at 56-mg and 84-mg doses was associated with a significant reduction in depressive symptoms at day 28 ( P < .001 for both), with corresponding effect sizes of 0.48 and 0.63, respectively.
Both doses of esketamine were also linked to significantly alleviated depressive symptoms at 24 hours post-first dose compared to placebo (P = .004 and P = .006, respectively).
Response and remission rates were significantly higher in both esketamine groups at all timepoints assessed than in the placebo group.
The most common treatment-emergent adverse events for combined doses of esketamine were nausea (25%), dissociation (24%), dizziness (22%), and headache (19%).
IN PRACTICE:
'This study supports esketamine monotherapy as an important option in the management of patients for whom [oral antidepressants] or other pharmacological treatments are no longer appropriate or acceptable,' the investigators wrote.
'Esketamine monotherapy can potentially address a significant unmet need for the especially vulnerable, untreated TRD subpopulation at risk of serious outcomes,' they added.
SOURCE:
The study was led by Adam Janik, MD, Department of Neuroscience, Johnson & Johnson, San Diego. It was published online on July 2 in JAMA Psychiatry.
LIMITATIONS:
The study's generalizability was limited by the exclusion of patients with significant psychiatric or medical comorbidities and substance dependence, as well as by limited racial and ethnic diversity among participants.
DISCLOSURES:
The study was funded by Janssen Research & Development. Several investigators reported being employees of, holding stocks in, or having financial ties with various organizations and pharmaceutical companies, including Johnson & Johnson and its Janssen division. Some investigators also reported holding patents for esketamine for the treatment of depression, with rights assigned to Johnson & Johnson.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
28 minutes ago
- Yahoo
Sarepta falls after gene therapy maker pauses Elevidys shipments in US
(Reuters) -Shares of Sarepta Therapeutics fell nearly 7% on Tuesday after the company agreed to comply with the U.S. health regulator's request to pause all shipments of its gene therapy Elevidys in the United States. The U.S. Food and Drug Administration on Friday asked Sarepta to voluntarily halt shipments of the gene therapy, but the company refused to do so and said it would continue making the treatment available to ambulatory patients. But Sarepta has now voluntarily and temporarily paused all shipments of the therapy, effective end of Tuesday. The company said the decision would allow it to respond to requests from the FDA and maintain a positive relationship with the agency. "Though Sarepta claims its pause in shipments was voluntary, we think the company moved preemptively — bracing for an inevitable FDA mandate to pull the drug," said H.C. Wainwright analyst Mitchell Kapoor. Shares of Sarepta fell 6.9% to $12.40 in early trading on Tuesday. "Sarepta's decision to comply was a capitulation after recognizing that the fight with the FDA was not winnable and that the agency would have strong-armed Sarepta into removing Elevidys with a formal demand," Kapoor added. Investor concerns regarding the use of the company's treatments have been heightened after the company on Friday disclosed that another patient who had received its experimental gene therapy died from acute liver failure, marking the third death this year. The company's shares have plummeted 89% so far this year. On Monday, Children's Hospital Los Angeles said it had paused usage of Elevidys in all patients with muscular dystrophy. The FDA's initial request had likely heightened the pressure on physicians to pause treatments, which could also have been a driving factor in Sarepta's decision, William Blair analyst Sami Corwin said. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
29 minutes ago
- Business Wire
Sutter Health Hospitals Deploy Wearable Ultrasound Tech to Personalize Fluid Management for Sepsis
SACRAMENTO, Calif. & LOS ANGELES--(BUSINESS WIRE)--Sutter Health, an integrated not-for-profit healthcare system based in Northern California, and Flosonics Medical today announced an expansion of the deployment of FloPatch, the first wireless wearable Doppler ultrasound device, across multiple hospital sites to support more precise and timely intravenous (IV) fluid management. This multisite deployment includes Sutter's Alta Bates Summit Medical Center, Summit Campus in Oakland and Sutter Santa Rosa Regional Hospital in Sonoma County. Implementations span the Emergency Department, Intensive Care Unit, Medical-Surgical Unit and Telemetry Unit. With these additions, six Sutter hospital campuses have now deployed FloPatch over the past year and include Sutter's Eden Medical Center in Castro Valley, Sutter's CPMC in San Francisco at CPMC Van Ness, Davies and Mission Bernal Campuses. IV fluid overload is a common complication in emergency and intensive care settings, in part because predicting a patient's response to fluids is complex. Individual needs can vary widely and shift quickly during critical illness. In studies of patients with sepsis and septic shock – a life-threatening condition caused by the body's overwhelming response to infection – nearly one-third were found to be fluid unresponsive¹. Without early identification of fluid unresponsiveness, patients may receive excessive fluids, increasing their risk of serious complications such as pulmonary edema, where fluid accumulates in the lungs. By some estimates, fluid overload can extend the average hospital stay by three days and increase healthcare costs by more than $15,000 per patient². FloPatch is an FDA-cleared, wearable device that provides clinicians with a fast and non-invasive way to perform hemodynamic assessments, measuring a patient's heart and blood flow response to IV fluids to help guide personalized fluid therapy. Clinical studies have shown that dynamic fluid assessments can reduce the need for mechanical ventilation and renal replacement therapy³,⁴, decrease ICU length of stay⁴, and are associated with lower mortality⁵. 'Our previous method of assessing fluid responsiveness was cumbersome and time-consuming. We often had to pull ICU nurses to perform evaluations in other units, which was disruptive and inefficient,' said Dr. Nader Emami, ICU medical director at Sutter Santa Rosa Regional Hospital. 'FloPatch streamlines the process with a simple, wearable device that empowers any member of the care team to perform this essential assessment faster and easier.' 'In emergency care, we often treat patients with complex needs, including people with sepsis,' said Dr. John Skovran, Emergency Department medical director at Sutter's Alta Bates Summit Medical Center, Summit Campus. 'We need a fast, reliable way to determine whether they'll benefit from fluids or be harmed by them. FloPatch gives us that clarity at the bedside in minutes, helping us make confident, timely decisions.' Joe Eibl, chief executive officer and co-founder of Flosonics Medical, noted: 'Sutter Health's multisite adoption of FloPatch reflects a growing recognition that wearable, real-time technologies play a transformative role in patient care. It's a great example of how forward-thinking health systems are meeting critical challenges with innovation.' Sutter Health prioritized staff training and thoughtfully integrated FloPatch into clinical workflows to make it a seamless part of care in intensive care and emergency medicine departments. About Sutter Health: Sutter Health is a not-for-profit healthcare system dedicated to providing comprehensive care throughout California. Committed to health equity, community partnerships, and innovative, high-quality patient care, Sutter Health is pursuing a bold new plan to reach more people and make excellent healthcare more connected and accessible. Currently serving more than 3.5 million patients, thanks to our dedicated team of more than 60,500 employees and clinicians, and 14,000+ physicians and advanced practice clinicians, with a unified focus on expanding care to serve more patients. Sutter delivers exceptional and affordable care through its hospitals, medical groups, ambulatory surgery centers, urgent care clinics, telehealth, home health, and hospice services. Dedicated to transforming healthcare, at Sutter Health, getting better never stops. Learn more about how Sutter Health is transforming healthcare at and About Flosonics Medical: Flosonics Medical is a medical device company engaged in the research and development of innovative ultrasound technology. Founded in 2015, the company's mission is to improve patient care and the practice of medicine through technology-enabled solutions and groundbreaking clinical research. For more information, please visit References: ¹ Hernández G, Ospina‑Tascón GA, Damiani LP, et al; ANDROMEDA‑SHOCK Investigators. Effect of a resuscitation strategy targeting peripheral perfusion status vs serum lactate levels on 28‑day mortality among patients with septic shock: the ANDROMEDA‑SHOCK randomized clinical trial. JAMA. 2019 Feb 19;321(7):654–664. doi:10.1001/jama.2019.0071 ² American Hospital Directory analysis of FFY2022 Medicare IPPS (MedPAR) claims data ³ Douglas IS, Alapat PM, Corl KA, Exline MC, Forni LG, Holder AL, et al. Fluid Response Evaluation in Sepsis Hypotension and Shock: A Randomized Clinical Trial. Chest. 2020 Oct;158(4):1431–1445. doi:10.1016/ ⁴ Latham HE, Bengtson CD, Satterwhite L, et al. Stroke volume–guided resuscitation in severe sepsis and septic shock improves outcomes. J Crit Care. 2017 Dec;42:42–46. doi:10.1016/ ⁵ Dubin A, Loudet C, Kanoore Edul VS, et al. Characteristics of resuscitation, and association between use of dynamic tests of fluid responsiveness and outcomes in septic patients: results of a multicenter prospective cohort study in Argentina. Ann Intensive Care. 2020 Apr 15;10(1):40. doi:10.1186/s13613-020-00659-7
Washington Post
30 minutes ago
- Washington Post
A rule lifting medical debt from credit scores was voided. What will change?
An estimated one-fifth of U.S. households have medical debt on their credit reports, a burden that makes it more expensive for them to buy homes, finance new cars and, in some cases, more difficult to obtain jobs. A recent court decision has now kept that system in place. A Biden-era rule, announced last summer but never put into effect, sought to forbid credit reporting agencies, including Equifax, Experian and TransUnion, from using medical debts over $500 on the detailed credit history reports that lenders use to judge creditworthiness. Amid opposition from industry groups and the Trump administration, a federal judge then struck down the rule earlier this month.
