The clinical trial will assess the effectiveness of Meru’s smartphone-based, 12-week treatment program at reducing depression among primary care patients. Meru’s intervention is part of a wave of new digital therapeutics that could expand access to treatment programs.
San Francisco-based Curebase has stepped up to help validate the technology, agreeing to handle clinical site selection, patient recruitment, and data collection and leverage its experience on similar projects.
“Curebase has a ton of unique experience in digital therapeutic and digital health studies, especially in the mental health space,” said a spokesperson for the company. “Curebase's model is particularly suited to the way Meru Health's study is being run. Access to primary care clinics and flexibility for remote participation is key.”
The DCT model used by Curebase involves a mix of local and remote care. Local clinicals are engaged in the studies but subjects can also participate remotely through Curebase’s eClinical DCT platform.
For the Meru project, the partners will split the study into two phases. In the first phase, 15 patients will receive Meru’s therapy and a further 15 patients will receive standard of care under the direction of their primary care physician.
That phase of the study is set to start enrolling soon and conclude in the spring of 2023. The study will tap into Curebase’s ability to enable patients to take part in research within the context of their primary healthcare.
“Curebase contracts with local primary care clinics that are interested in having their patients participate in the study,” said the spokesperson. “These PCP clinics are educated about the study/product and given the opportunity to identify patients within their care that may be good candidates. They are encouraged to have conversations with their patients that may qualify.”
The second, randomized phase of the study will enroll 300 participants and eight primary care clinics in the US. Curebase and Meru will use patient-reported outcomes to track the effect of the intervention.