Late-Onset Depression: A Distinct Indication?
Chairs: Peter de Boer, PhD; Patricia Capaccione, RPh
Spring 2018 – Call for participation in on-going working group. Will convene quarterly to develop White Paper. To participate, Contact ISCTM
Most Recent Activity: Inaugural Working Group session 14th Annual Scientific Meeting, 20 February 2018, Washington DC
VIEW SLIDE PRESENTATION
Deliverable: White Paper
Working Group Objectives
Major depressive disorder (MDD), is a serious, recurrent, and disabling psychiatric illness associated with excess mortality and with years of potential life lost. Depression with an onset later in life (a.k.a. late-onset depression), is associated with disability, increased mortality, and poorer outcomes from physical illness. Emerging data suggest that late-onset depression is a distinct entity with a pathophysiology, etiology, trajectory and treatment response different from adult MDD. The objective of this working group is to explore from a clinical and regulatory perspective these questions/topics:
- How to identify subjects with late-onset depression. In addition to age, what distinguishes this population from the general MDD population? Is there a role for biomarkers?
- How to demarcate the population with late-onset depression from those with vascular cognitive disorders and early-onset depression in older adults. Explore the medical needs for the late-onset depression population.
- Is there enough evidence of late-onset depression being a distinct entity to support the development of a potential path forward to obtain a regulatory approval in this indication?
Membership will consist of representatives of different functions from academia, including mood specialists, geriatric specialists, regulatory experts and geriatric psychiatrists, as well as Regulatory Authorities.
A guidance document summarizing the discussions from this meeting and potential next steps.