NCT05966532Active, not recruiting
Emotional Cognition: Establishing Constructs and Neural-Behavioral Mechanisms in Older Adults With Depression
Emotional Cognition: Establishing Constructs and Neural-Behavioral Mechanisms in Older Adults With Depression (ENSURE; R21 MH130870)
Source: ClinicalTrials.gov · Last updated 30 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 276 (estimated)
- First submitted
- 21 Jul 2023
- Start date
- 11 Dec 2023
- Primary completion date
- 1 Jun 2027
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Depression
- NCT number
- NCT05966532
What you commit to
- Study type: Observational
- Planned participants: 276
- From 11 Dec 2023 to the primary completion date, 1 Jun 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of medications with known impacts on neurocognitive function (e.g., acetylcholinesterase inhibitors, amphetamine, methylphenidate, vortioxetine, sedatives)
- Contraindication to MRI and MEG (only for depressed participants) (e.g., any electronic / metallic implants near or within the head or body, claustrophobia)
Other illness
- History of bipolar disorder, schizophrenia, or schizoaffective disorder
- Lifetime central nervous system (CNS) disease (including head injury with loss of consciousness \> 5 minutes)
- History of neurodevelopmental disorder (e.g., Autism spectrum disorder)
- Alcohol/substance use disorder within past 3 months
- DSM-5 diagnosis of major cognitive impairment
- Current sensory or physical impairment that interferes with testing.
Age
- History of medical conditions that can affect neurocognitive function as well as be confounded with age (e.g., thyroid disease, endocrine illnesses)
Other
- Presence of psychotic features
- Women who are pregnant
Who the study is looking for
- Male and female participants
- Age between 21-80 years old
- DSM-5 diagnosis of major depressive disorder (MDD) based on Mini Neuropsychiatric Interview
- Inventory of Depressive Symptomatology-Clinician Rated version (IDS-C) total score \> 14
- Able to read, write, and comprehend English
- Provide informed consent; willing to comply with study protocol
Age in the registry: 21 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Arlington Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.