Synergy in Action

Late-Onset Depression: A Distinct Indication?

Chairs: Peter de Boer, PhD; Patricia Capaccione, RPh

Current Activity:

Most Recent activity:
Working Group Session – 15th Annual Scientific Meeting – View Summary – 21 February 2019, Washington DC

Spring 2018 – Call for participation in on-going working group. Will convene quarterly to develop White Paper.  To participate, Contact ISCTM
Inaugural Working Group session  14th Annual Scientific Meeting, 20 February 2018, Washington DC
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.