Decentralized clinical trial company Curebase is partnering with Meru Health on a three-year clinical trial to study the effectiveness of Meru's 12-week treatment program aimed at reducing depression among primary care patients. 

Meru Health's smartphone-based, therapist-guided treatment program targets depression, burnout and anxiety, while Curebase provides a decentralized clinical trial platform connecting researchers with trial participants, streamlining the paperwork and allowing for remote study management. 

The two-phase trial will begin with a proof-of-concept phase, where 15 patients will use Meru Health's treatment program. Another 15 will undergo traditional treatment methods, such as face-to-face therapy, antidepressants or combination therapy, under the supervision of their primary care physician.

Once the proof-of-concept phase concludes, the two companies will collaborate for a randomized controlled trial (RCT), which will include 300 participants and eight primary care clinics within the U.S.  

During the RCT, Curebase and Meru Health will collect electronic patient-reported outcomes for analysis. After participants complete the treatment program, researchers will monitor their progress for up to a year to evaluate the sustained effects of the Meru's treatment program compared to standard treatment methods. 

The trial was funded by the National Institutes of Health's Small Business Innovation Research program and is slated to begin recruitment in autumn 2022. It's expected to conclude by spring 2023. 

"Too many people who are struggling with mental health issues also struggle with gaining access to effective treatment and our solution was created to help these people," Kristian Ranta, founder and CEO of Meru Health, said in a statement. "Curebase is an ideal partner for us because the company's DCT platform and support services allow us to focus on the clinical aspects of these trials, while treating participating patients at a variety of locations."

THE LARGER TREND

A number of digital health companies offer technology for conducting decentralized clinical trials, including Medable, Reify Health and THREAD. Curebase recently closed a $40 million Series B funding round, bringing its total raise to $59 million.

Digital mental health continues to be a popular clinical area for investment, even as overall digital health funding has declined so far in 2022. Meru raised $38 million in Series B equity and debt funding last year, following an $8.1 million Series A in 2020. 

"Meru Health's smartphone-based mental health program shows tremendous potential for bringing effective and accessible treatment to the growing population of depression and anxiety patients," Curebase CEO and founder Tom Lemberg said in a statement. "We're excited to be working with Meru Health on clinical research that has the potential to benefit millions of Americans."