Decentralized clinical trials company Curebase is collaborating with Meru Health on a three-year clinical study to evaluate the effectiveness of Meru’s 12-week treatment program aimed at reducing depression in primary care patients.
Meru Health’s smartphone-based, therapist-led treatment program targets depression, burnout and anxiety, while Curebase offers a decentralized clinical trial platform that connects researchers with trial participants, streamlines paperwork and enables remote trial management.
The two-phase study begins with a proof-of-concept phase that will enroll 15 patients Meru Health’s treatment program. Another 15 will undergo traditional treatments such as face-to-face therapy, antidepressants or combination therapy under the supervision of their GP.
Once the proof-of-concept phase is complete, the two companies will collaborate on a randomized controlled trial (RCT) that will include 300 participants and eight US primary care clinics
During the RCT, Curebase and Meru Health will electronically collect patient-reported results for analysis. After participants complete the treatment program, researchers will monitor their progress for up to a year to assess the lasting effects of Meru’s treatment program compared to standard treatment methods.
The process was funded by the The National Institutes of Health’s Small Business Innovation Research (SBIR) program is scheduled to begin recruitment in fall 2022 and is expected to conclude in spring 2023.
“Too many people struggling with mental health issues also struggle to access effective treatment, and our solution was designed to help those people,” said Kristian Ranta, Founder and CEO of Meru Health, in an explanation. “Curebase is an ideal partner for us as the company’s DCT platform and support services allow us to focus on the clinical aspects of these studies while treating the participating patients at different sites.”
THE BIGGER TREND
A number of digital health companies offer technologies for conducting decentralized clinical trials, including: Medable, Reify Health, and THREAD. Curebase recently closed a $40 million Series B funding round, bringing total funding to $59 million.
Digital mental health remains a popular clinical area for investment, including overall Funding for digital health has declined so far in 2022. Meru has raised $38 million in Series B equity and debt financings over the past year, following an $8.1 million Series A funding in 2020.
“Meru Health’s smartphone-based mental health program shows tremendous potential to provide effective and accessible treatment to the growing population of depression and anxiety sufferers,” said Tom Lemberg, CEO and founder of Curebase, in a statement. “We are excited to partner with Meru Health on clinical research that has the potential to benefit millions of Americans.”