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Clinical Trials

Date: 2017-08-02

Type of information: Initiation of patient enrollment

phase:

Announcement: initiation of patient enrollment

Company: 23andMe (USA - CA) Lundbeck (Denmark) Milken Institute (USA - CA)

Product:

Action mechanism:

Disease: major depressive disorder, bipolar depression

Therapeutic area: CNS diseases - Mental diseases

Country:

Trial details:

Latest news:

  • • On August 2, 2017, 23andMe, working in collaboration with the Milken Institute and Lundbeck, began enrolling for a first-of-its kind genetic study designed to gain understanding of the underlying biology of major depressive and bipolar disorders. This study will combine cognitive assessments with genetic data and survey responses to assess how genes influence brain processes – such as attention, decision-making and visual perception — in individuals who live with these serious mental health conditions.
  • To conduct this research, 23andMe intends to recruit 15,000 people with major depressive disorder and 10,000 people with bipolar disorder. The study is open to anyone ages 18- to 50-years-old who has been diagnosed by a physician with major depressive disorder or bipolar disorder, has been prescribed medication to treat his/her condition, lives in the United States and has access to the internet through a desktop or laptop computer.
  • The study will address two main challenges in treating major depressive and bipolar disorders; the fact that patients can be very different both with regards to symptoms and to the biological processes leading to these symptoms. Patients may also respond very differently to treatment.
  • As part of the study, consenting participants will receive the 23andMe Personal Genome Service® at no cost, including more than 75 personalized genetic reports about their health, traits and ancestry. Study participants will provide a saliva sample for DNA genotyping, and then complete nine monthly online cognitive assessment sessions that each last between 10-30 minutes. Participants’ de-identified data will be analyzed for clues as to how genetics and environmental factors combine to impact brain function and behavior.
  • 23andMe has already co-authored a study identifying 15 genetic regions linked to depression in August 2016. The launch of this new study furthers 23andMe’s genetic discovery efforts.
  • Further, Lundbeck hopes that the study results will reveal ways of how to decompose the heterogeneity of the patient populations. This knowledge would be fuelled directly into the company's research and development efforts to develop future treatments.
 

Is general: Yes