- The prospective observational study involved 30 participants, aged 18-65, with a clinical diagnosis of mild to moderate depression who have been prescribed antidepressant monotherapy for MDD. The study had two co-primary objectives: to evaluate feasibility and participant compliance on measures of mood and cognition on wearable technology; and to compare measures of mood and cognition on wearable technology using traditional neuropsychological testing and patient reported outcomes on depression symptoms at 6 weeks. Participants were provided with an Apple Watch on which brief cognitive and mood tests were administered daily.
The researchers observed that patients were compliant with the wearable device on a daily basis to evaluate mood (95 percent) and cognition (96 percent). The study also demonstrated that abbreviated daily assessments delivered through the wearable device corresponded with objective Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive tests and full-length patient reported outcomes, PHQ-9 and PDQ-D, assessed during weeks 1, 3 and 6. No adverse events were reported in the study.
"We are delighted that people living with MDD engaged with Cognition Kit on the Apple Watch so well," said Ben Fehnert, Director at Cognition Kit. "We remain focused on our mission to understand mental health through regular interactions with mobile and wearable technology and to put that information into the hands of patients, researchers and healthcare professionals."
"This initiative is an excellent example of the pilot work being done at Takeda to build a body of evidence for new ways of measuring outcomes in mental health. Technology may allow us to create real time objective measurements for assessing effects in depression that could transform patient care by increasing our ability to estimate clinical conditions and support earlier engagement between the patient and clinician. We are encouraged by the study results and look forward to learning more about the intersection of technology and healthcare," said Nicole Mowad-Nassar, vice president, external partnerships, at Takeda Pharmaceuticals U.S.A.
Given the exploratory nature of these study findings, they will be hypothesis generating and will contribute to decision making for future clinical studies involving wearable technology.
About Major Depressive Disorder
According to the American Psychiatric Association (APA), authors of Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V), MDD is a combination of symptoms that affects how you feel, the way you think and how you act. In addition to depressed mood or sadness, MDD symptoms include loss of interest, changes in appetite or weight, insomnia or oversleeping, loss of energy, restlessness or having slowed speech and movements, feelings of worthlessness or guilt, difficulty thinking or making decisions and thoughts of suicide. MDD includes five or more of these symptoms with at least one core symptom of either depressed mood or loss of interest or pleasure.i
About Cognition Kit Limited
Cognition Kit is a software platform for mobile and wearable technology, designed to capture high frequency patient-centered outcomes. Cognition Kit takes research out of the lab and into daily life, enabling doctors, scientists and the public to better understand and manage brain health and enhance patient care. Cognition Kit is a joint venture between Cambridge Cognition and Ctrl Group.
About Takeda Pharmaceuticals U.S.A., Inc. Takeda Pharmaceutical Company Limited is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Takeda's growth is being fuelled by products, especially in oncology and gastroenterology, as well as its presence in emerging markets. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.
Takeda Pharmaceuticals U.S.A., Inc. is located in Deerfield, Ill., and is the U.S. commercial organization of Takeda Pharmaceutical Company Limited.
Additional information about Takeda is available through its corporate website, www.takeda.com, and additional information about Takeda Pharmaceuticals U.S.A., Inc. is available through its website, www.takeda.us.
i Diagnostic and Statistical Manual of Mental Disorders (DSM-5). (5th ed., 155-188). America Psychiatric Association, 2013.
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