Clinical Trial

Emotional Cognition: Establishing Constructs and Neural-Behavioral Mechanisms in Older Adults With Depression

Study acronym: ENSURE
Active, Not Recruiting
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Summary
This is a cross-sectional pilot study designed to establish hot and cold cognitive functions and underlying neurocircuitry in older adults with MDD. The investigators will study 120 participants aged 21-80 years old with MDD. All participants will undergo clinical and neurocognitive assessment, and Magnetoencephalography (MEG)/Magnetic resonance imaging (MRI) procedures at one time point. The investigators will also enroll 120 demographically matched comparable, never-depressed healthy participants (controls) to establish cognitive benchmarks. Healthy controls will complete clinical and neurocognitive measures at one time point. To attain a balanced sample of adults across the lifespan, the investigators will enroll participants such that each age epoch (e.g., 21-30, 31-40, etc.) has a total of ten subjects (n=10) in both the healthy control cohort and depressed cohort.
Protocol Amendment History 2 changes
notable Primary completion pushed: 2026-06-01 -> 2027-06-01 2026-07-31
minor Completion pushed: 2026-08-31 -> 2027-08-31 2026-07-31
Trial Details
NCT Number NCT05966532
Lead Sponsor University of Texas Southwestern Medical Center
Collaborators: The University of Texas at Arlington, National Institute of Mental Health (NIMH), JERRY M LEWIS MENTAL HEALTH RSRCH FDTN
Conditions Major Depressive Disorder (MDD), Healthy Adult Volunteer
Enrollment 276 participants
Start Date 2023-12-11
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-30