Digital App Effective for Schizophrenia in Phase 3 Trial
Top-line results from the CONVOKE trial, which included 464 US adults with schizophrenia, showed that CT-155 plus standard-of-care antipsychotic therapy was associated with significantly reduced negative symptoms between baseline and week 16, meeting the study's primary endpoint.
CT-155 was well tolerated and demonstrated a favorable safety profile similar to previous studies, the release said.
'The observed clinical benefit on experiential negative symptoms in this study, without additional known safety concerns, marks a critical advancement in understanding how we might address this long unmet need,' Shaheen Lakhan, MD, PhD, chief medical and scientific officer of Click Therapeutics, said in the release.
Unmet Need
Although available treatments have been used to help manage negative symptoms of schizophrenia, there is currently no approved treatment specifically for negative symptoms in the US, the companies noted.
CT-155 was granted Breakthrough Device Designation by the FDA in 2024. So far, it is the only app designed solely for schizophrenia to have received this designation.
Last year, the FDA approved the first new schizophrenia treatment in decades. But research reported earlier this year offered disappointing results from a phase 3 trial of that drug, xanomeline/trospium chloride (Cobenfy, Bristol Myers Squibb).
As reported by Medscape Medical News , this has resulted in many clinicians becoming more open to exploring digital and technical solutions — including at this year's American Psychiatric Association (APA) annual meeting, where most research poster sessions featured presentations on apps targeting psychiatric conditions, including schizophrenia.
CT-155 is a mobile app-based software designed to address negative symptoms of schizophrenia by providing interactive psychosocial techniques when used alongside standard pharmaceutical treatment. The app needs to be prescribed by a healthcare professional and is then installed onto smartphones.
While the World Health Organization estimates that approximately 24 million people worldwide have schizophrenia, about 60% of them experience negative symptoms.
These types of symptoms involve an absence or reduction of behaviors and functions considered normal, including blunted affect, reduced speech, and social withdrawal. Positive schizophrenia symptoms, on the other hand, are those that add experiences or perceptions, such as hallucinations, delusions, and paranoia.
Detailed Results Coming Soon
CONVOKE is a randomized, double-blind, multicenter, phase 3 trial. Its primary endpoint was reduction in experiential negative symptoms from baseline to week 16, as measured using the Clinical Assessment Interview for Negative Symptoms, Motivation, and Pleasure Scale (CAINS-MAP), for CT-155 vs a digital control app used along with standard-of-care antipsychotic therapy.
Other endpoints, including change from baseline to week 8 on the CAINS-MAP and improvement on the Patient Global Impression of Improvement Scale at weeks 8 and 16 have not been released yet.
However, detailed results from CONVOKE are scheduled to be presented in October at the European College of Neuropsychopharmacology Congress' Novel Therapeutics Symposium.
Before today's results were announced, John Torous, MD, psychiatrist and director of Digital Psychiatry at Beth Israel Deaconess Medical Center in Boston, voiced his optimism about the study at the APA meeting and told Medscape Medical News he hoped the product could roll out quickly if it proved to be effective.
After the results were released, he tweeted, 'Impressive results for a new app to support people with schizophrenia, given the study features a rigorous digital control group.' Torous added that he is 'excited to see such advances in digital health.'
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
3 minutes ago
- Yahoo
Cardinal Health shares drop as revenue misses expectations despite raised outlook
-- Cardinal Health (NYSE:CAH) shares fell 2.9% on Tuesday after the healthcare services company reported fourth-quarter revenue that missed analyst expectations, despite raising its fiscal 2026 earnings guidance. The company reported fourth-quarter revenue of $60.2 billion, relatively flat compared to the same period last year and below the analyst consensus of $60.92 billion. However, revenue increased 21% when excluding the impact of a previously communicated contract expiration with OptumRx. Adjusted earnings per share came in at $2.08, exceeding analyst expectations of $2.03. The 13% year-over-year increase in adjusted EPS was driven by a 19% rise in non-GAAP operating earnings to $719 million, with all five operating segments growing profit by double digits. "Fiscal 2025 was a transformative year for Cardinal Health, and we closed the year with momentum, delivering strong fourth quarter results," said Jason Hollar, CEO of Cardinal Health. "The broad-based operational strength, with all five of our operating segments growing profit double-digits, reflects the disciplined execution of our strategy and our investments for growth." For the full fiscal year 2025, Cardinal Health reported revenue of $222.6 billion, a 2% decrease from fiscal 2024, though revenue increased 18% excluding the OptumRx contract expiration. Adjusted EPS for the year rose 9% to $8.24. The company raised its fiscal 2026 adjusted EPS guidance to $9.30-$9.50, up from its previous outlook of $9.10-$9.30 and above the analyst consensus of $9.25. Cardinal Health also announced the acquisition of Solaris Health, described as the country's leading urology MSO with over 750 providers. Cardinal Health generated $2.5 billion in adjusted free cash flow for fiscal 2025 and expects $2.75-$3.25 billion for fiscal 2026. Related articles Cardinal Health shares drop as revenue misses expectations despite raised outlook Victoria's Secret Exposed: The Warning Sign Behind the Stock's 52% Collapse Clients buying into summer rally, bracing for later pullback, says BofA's Hartnett
Medscape
4 minutes ago
- Medscape
Do Designated Pharmacists Make Cancer Care Safer?
TOPLINE: Adding a designated pharmacist to hematology-oncology teams reduced adverse drug reaction (ADR) rates by 62% (age-adjusted hazard ratio [AHR], 0.38). The pharmacist made 588 recommendations with a 95% implementation rate, identifying 287 medication errors. METHODOLOGY: A parallel randomized clinical trial conducted from July 2020 to October 2022 included 182 patients randomly assigned in a 1:1 ratio to receive comprehensive pharmacist intervention or standard care. Participants were monitored over a 4-month intervention period and 1 month afterward, with the pharmacist evaluating treatments, providing medication counseling, and making recommendations to physicians in the intervention group. Research took place in the hematology-oncology unit of a medical center owned by Clalit Health Services, with two outpatient clinics staffed by 8 hematology-oncologists, 10 nurses, 1 social worker, and 1 half-time pharmacist. Unrelated pharmacologist physicians determined which recommendations were medication errors and assessed their severity levels using the Harm Associated with Medication Error Classification. TAKEAWAY: The intervention group demonstrated lower ADR rates (AHR, 0.38; 95% CI, 0.23-0.65; P < .001) for at least one ADR and (AHR, 0.25; 95% CI, 0.09-0.67; P = .006) for at least one moderate or severe ADR. The designated pharmacist made 588 recommendations for the intervention group, with a 95% implementation rate, identifying 287 as medication errors. Analysis revealed higher detection of administration errors (incidence rate ratio, 2.61; 95% CI, 1.38-4.92; P = .003) and a higher proportion of potentially serious medication errors (P = .003) in the intervention group. Integration of an oncology pharmacist into hematology-oncology clinics reduced ADRs and improved the detection and prevention of potentially serious medication errors. IN PRACTICE: 'Incorporating oncology-trained pharmacists into hematology-oncology care teams is an effective strategy for reducing ADR rates and enhancing medication safety,' wrote the authors of the study. SOURCE: The study was led by Areen Khateeb Alabbasi, PhD, School of Public Health, University of Haifa in Haifa, Israel. It was published online in JCO Oncology Practice. LIMITATIONS: The single-center design and focus on hematologic malignancies may limit the generalizability of the findings. Information bias could have affected ADR assessments, as only physician-documented cases were included. The sample size limited statistical power for identifying significant differences in some secondary outcomes, such as emergency department visits and hospitalizations. The study did not include patient-reported outcomes or clinician feedback. Additionally, no financial information was provided to assess the cost-effectiveness of the model. DISCLOSURES: Naama Schwartz reported being employed by Medtronic and serving as a lecturer at the University of Haifa, School of Public Health. Schwartz also disclosed being the CEO of Hepacure Pharma, an early-stage biotech company established in September 2024 that develops peptides for fatty liver diseases. Shmuel Klang reported serving in consulting or advisory roles for Novo Nordisk and Novartis. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Gizmodo
4 minutes ago
- Gizmodo
Fitbit Versa 4 Fitness Smartwatch Restocked as a Flash Offer, Feels Like Black Friday in August
Keeping fit is a lot of effort, and while it may well be rewarding, a lot of people hit a plateau and then really struggle to push through that. A large part of that comes down to the fact that your improvements aren't always easy to see, whether in the mirror or on the scales. Better health tracking can help though, and that's where a great smartwatch can really shine. If you're looking for a really good option, then you'll want to go ahead and get this Fitbit Versa 4 Fitness Smartwatch while it's 25% off. That means it's down to $150, which is an excellent price, and a small amount to pay for peace of mind when it comes to your training. See at Amazon Smartwatches have been a real game-changer when it comes to fitness. You'd normally have to pay good money, or learn a lot, to be able to accurately track some of the things fitness smartwatches can do with ease. It means that getting one is an investment of sorts, but one that's often a lot cheaper than getting all of the things you'd need to cover all of your bases otherwise. The Fitbit Versa 4 Fitness Smartwatch, first of all, is a lot smaller than some other smartwatches. It means that it just doesn't take up as much room on your wrist, which can be nice for those who don't want clunky accessories. Outside of the fitness stuff, it has a GPS functionality to allow you to keep an eye on where you are and where you're going, which is lovely if you're someone getting into hiking or forest trails. In terms of your health, it can track not only all of your heart rate and sleep stuff, but actually has a bunch of modes dedicated to different exercises as well, so you can get more accurate results. It even offers advice on your sleep, to help you rest a bit better, and it makes it easy to see when you should be working harder or taking a break. It even works for all the usual smartwatch stuff like notifications, paying for things with Google Wallet, and it comes with a six-month Premium subscription for the best possible results. That's a lot of great stuff for $200, but that's not what you're going to be paying. Instead, while this limited-time deal is on, you can get it for $150. We recommend acting quickly on this one, because we're not expecting it to last for long. See at Amazon
