Takeda, Lundbeck plan U.S. test for depression app in latest beyond-the-pill foray

Can keeping track of medication doses and mood swings help improve depression treatment? Takeda is tackling another beyond-the-pill tech project aimed at finding out.

The pharma has teamed with Lundbeck and Advocate Health Care on a study that uses an app with a "conversational text interface" to track and measure patients’ experience on antidepressant therapies. During the study, users will record medications, moods, side effects and other general well-being measurements every day for 12 weeks. All study participants will have been prescribed some kind of antidepressant by their physicians.

The recorded information is designed to serve as a feedback mechanism for patients—to inform them of their own progress or problems—as well as a tool for communicating with physicians, said Dr. Darryl Sleep, VP and head of Takeda’s U.S. medical office and U.S. medical affairs. For instance, if a patient who is not doing well records thoughts about suicide, the app will trigger a message to their healthcare provider.

It's the latest effort by the Japan-based drugmaker to add digital to the depression-therapy toolbox. The Advocate Pathway app study builds on another app pilot study that Takeda launched with Cognition Kit in the U.K. earlier this year. In that test, participants are wearing Apple Watches with an app that collects both passive and active data from people with major depressive disorder. And last year, Takeda sponsored a Shark Tank-like innovation contest to draw submissions for digital solutions for depression.

"Our interest here is to improve the wellness of patients, and our medicine is only part of that. We recognize that we can’t do this alone and need to be a partner in the broader healthcare system, particularly in the U.S.," Sleep said in an interview. "A prescription for an antidepressant to a patient with depression is really not addressing the fundamental problem of depression."

Results from the pilot study are expected in spring or summer of 2018. While Advocate is handling patient recruitment and marketing to attract participants now, if the app works, Takeda will take a more active approach in getting it out to patients who need it, Sleep said.

"If this really does improve outcomes based on well-defined, standard-of-care measurements for patients with treatment for depression, we would want to partner with other stakeholders in the healthcare community to make sure it’s utilized widely—although again, not linking it to any particular medicine," he said.

Takeda holds the U.S. marketing rights to Trintellix under a marketing deal with Lundbeck, and last year launched a TV marketing campaign to promote the drug after a name change from Brintellix. The Trintellix "Tangles" campaign is still running, now with a new commercial that extends the message that depression is a tangle of multiple symptoms. Global sales of Trintellix for the first nine months of 2017 reached DKK 1,195 million, according to Lundbeck financials, which is a 55% year-over-year increase.