- Lundbeck A/S and 23andMe Inc. are working on a huge project: a 25,000-person study looking at the role genetics play in depression.
- The companies, along with Milken Institute, a California-based think tank and collaborator on the study, plan to recruit 15,000 patients with major depressive disorder (MDD) and 10,000 patients with bipolar disorder (BD). Official enrollment began Wednesday, according to 23andMe's Manager of Research Communities Anna Faaborg.
- Study participants are required to provide their DNA through a saliva sample, then complete monthly surveys and cognitive tests on a desktop or laptop. Farboorg said the study will conclude about 10 months after investigators enroll the last patient, meaning a readout won't happen until roughly 18 months to two years after enrollment ends because of the time it will take to analyze data coming from the study.
Such a large study presents obvious challenges. While 23andMe declined to comment on the cost-breakdowns of the investigation — citing contractual restrictions — it did note the inherently arduous tasks of enrolling thousands of MDD and BD patients, whose conditions can often vary widely in severity, as well as keeping them adherent to the study protocols.
"One of the challenges we've been thinking through is how do we keep people engaged and coming back and completing the studies," Faaborg said.
"A nine-month study — this is going to be the most intensive study we've done so far," she added. "Our other studies have had longitudinal surveys, but they've been more spread out, maybe every two to three months. We're asking people to do a survey every month and also cognitive assessments, which is a new data collection type for us. So they have to make sure they're at a desktop or laptop, these tasks are not mobile accessible."
Still, the study backers remain confident in their abilities.
Though Lundbeck didn't respond to BioPharma Dive request for comment by publication time, the company has a history of developing and marketing neurological drugs such as Abilify (aripiprazole). 23andMe, meanwhile, says it has tackled engagement concerns before — experience it can bring to this latest endeavor.
"We've been able to do it fairly successfully for the rest of our studies, but again this is a little bit different than what we've done before so we're trying to think through different strategies."
To participate in the study, patients must be between 18 and 50, have been physician-diagnosed for MDD or BD, have been prescribed medication for their conditions, have internet access through a desktop or laptop, and live in the U.S.