Understanding emotional cognition in older adults with depression

Emotional Cognition: Establishing Constructs and Neural-Behavioral Mechanisms in Older Adults with Depression (ENSURE; R21 MH130870)

This study is trying to understand how depression affects thinking and emotions in older adults by comparing them to healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 276 (estimated)
• Ages: 21 Years to 80 Years
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (other)
• Locations: 2 sites (Arlington, Texas and 1 other locations)
• Trial ID: NCT05966532 on ClinicalTrials.gov

What this trial studies

This observational pilot study aims to explore both hot and cold cognitive functions and their underlying neurocircuitry in older adults diagnosed with Major Depressive Disorder (MDD). It will involve 120 participants aged 21-80 years with MDD, who will undergo clinical assessments and advanced imaging techniques like Magnetoencephalography (MEG) and MRI. Additionally, 120 healthy participants will be included as controls to establish cognitive benchmarks. The study seeks to differentiate between cognitive functions influenced by emotional stimuli and those that are not, which could inform future treatment strategies for MDD.

Who should consider this trial

Good fit: Ideal candidates include adults aged 21-80 with a DSM-5 diagnosis of Major Depressive Disorder and a specific symptom severity score.

Not a fit: Patients with a history of bipolar disorder, schizophrenia, or other significant CNS diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and targeted treatments for cognitive dysfunction in patients with depression.

How similar studies have performed: While there is limited information on hot cognitive functions in MDD, previous studies have shown success in exploring cold cognitive functions, making this approach novel.

Eligibility criteria

Inclusion Criteria:

1. Male and female participants
2. Age between 21-80 years old
3. DSM-5 diagnosis of major depressive disorder (MDD) based on Mini Neuropsychiatric Interview
4. Inventory of Depressive Symptomatology-Clinician Rated version (IDS-C) total score \> 14
5. Able to read, write, and comprehend English
6. Provide informed consent; willing to comply with study protocol

Exclusion Criteria:

1. History of bipolar disorder, schizophrenia, or schizoaffective disorder
2. Presence of psychotic features
3. Lifetime central nervous system (CNS) disease (including head injury with loss of consciousness \> 5 minutes)
4. History of neurodevelopmental disorder (e.g., Autism spectrum disorder)
5. History of medical conditions that can affect neurocognitive function as well as be confounded with age (e.g., thyroid disease, endocrine illnesses)
6. Women who are pregnant
7. Current use of medications with known impacts on neurocognitive function (e.g., acetylcholinesterase inhibitors, amphetamine, methylphenidate, vortioxetine, sedatives)
8. Alcohol/substance use disorder within past 3 months
9. DSM-5 diagnosis of major cognitive impairment
10. Current sensory or physical impairment that interferes with testing.
11. Contraindication to MRI and MEG (only for depressed participants) (e.g., any electronic / metallic implants near or within the head or body, claustrophobia)

Where this trial is running

Arlington, Texas and 1 other locations

• University of Texas Arlington — Arlington, Texas, United States (NOT_YET_RECRUITING)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Shawn McClintock, PhD

Conditions: Major Depressive Disorder, Healthy Adult Volunteer, Emotional Cognition