Status:

COMPLETED

Fitness for Brain Optimization for Late-Life Depression

Lead Sponsor:

University of Pittsburgh

Collaborating Sponsors:

National Institute of Mental Health (NIMH)

Conditions:

Depression in Old Age

Eligibility:

All Genders

60+ years

Phase:

NA

Brief Summary

Cognitive impairment and brain abnormalities are common and persist after depression remission in those with Late Life Depression (LLD), compounding dementia risk in both individuals with acute and re...

Detailed Description

Significance: The population of adults aged \>65 years in United States is expected to nearly double between 2012 and 2050, with a projected estimate of 83.7 million adults aged \>65 years by 2050. T...

Eligibility Criteria

Inclusion

  • Men and women 60+ years
  • Major Depressive Episode in older adulthood (since age 55)
  • Current level of depressive symptoms does not meet criteria for a Major Depressive Episode
  • Ambulatory without pain or the assistance of walking devices
  • Able to speak and read English
  • Exercise level of \<100 minutes per week on average
  • Medical clearance by primary care physician (PCP)
  • Living in community for duration of the study
  • Reliable means of transportation
  • No diagnosis of a neurological disease
  • Eligible to undergo MRI

Exclusion

  • Current diagnosis of a Major Depressive Episode
  • Psychosis
  • Significant suicide risk (i.e., current, active suicidal ideation with a plan)
  • Electroconvulsive therapy within the past 12 months
  • Engaging in moderate-intensity exercise \>100 minutes per week on average
  • Current treatment for cancer - except non-melanoma skin
  • Neurological condition (MS, Parkinson's, Dementia, MCI) or brain injury (Stroke)
  • Substance Use disorder in the past 3-months
  • Current treatment for congestive heart failure, angina, uncontrolled arrhythmia, deep vein thromboses (DVT) or other cardiovascular event
  • Myocardial infarction, coronary artery bypass grafting, angioplasty or other cardiac condition in the past year including uncontrolled hypertension
  • Regular use of an assisted walking device
  • Presence of metal implants (pacemaker, stents) that would be MR ineligible
  • Claustrophobia
  • Color Blindness
  • Significant visual or hearing impairments that would preclude neuropsychological assessment or communication with study staff via a virtual format (videoteleconference)
  • Not fluent in English
  • Not medically cleared by PCP
  • Traveling consecutively for 3+ weeks during the study
  • MOCA (\<20 to exclude) and MADRS (\>9 to exclude)

Key Trial Info

Start Date :

August 4 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 22 2025

Estimated Enrollment :

46 Patients enrolled

Trial Details

Trial ID

NCT04670510

Start Date

August 4 2021

End Date

October 22 2025

Last Update

November 28 2025

Active Locations (1)

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1

UPMC Western Psychiatric Hospital

Pittsburgh, Pennsylvania, United States, 15213