RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-12-11
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05966532

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male and female participants
  2. 2. Age between 21-80 years old
  3. 3. DSM-5 diagnosis of major depressive disorder (MDD) based on Mini Neuropsychiatric Interview
  4. 4. Inventory of Depressive Symptomatology-Clinician Rated version (IDS-C) total score \> 14
  5. 5. Able to read, write, and comprehend English
  6. 6. Provide informed consent; willing to comply with study protocol
  1. 1. History of bipolar disorder, schizophrenia, or schizoaffective disorder
  2. 2. Presence of psychotic features
  3. 3. Lifetime central nervous system (CNS) disease (including head injury with loss of consciousness \> 5 minutes)
  4. 4. History of neurodevelopmental disorder (e.g., Autism spectrum disorder)
  5. 5. History of medical conditions that can affect neurocognitive function as well as be confounded with age (e.g., thyroid disease, endocrine illnesses)
  6. 6. Women who are pregnant
  7. 7. Current use of medications with known impacts on neurocognitive function (e.g., acetylcholinesterase inhibitors, amphetamine, methylphenidate, vortioxetine, sedatives)
  8. 8. Alcohol/substance use disorder within past 3 months
  9. 9. DSM-5 diagnosis of major cognitive impairment
  10. 10. Current sensory or physical impairment that interferes with testing.
  11. 11. Contraindication to MRI and MEG (only for depressed participants) (e.g., any electronic / metallic implants near or within the head or body, claustrophobia)

Contacts and Locations

Study Contact

Shawn McClintock, PhD
CONTACT
214-648-2806
shawn.mcclintock@utsouthwestern.edu
Aatika Parwaiz, MPH
CONTACT
214-648-2806
aatika.parwaiz@utsouthwestern.edu

Study Locations (Sites)

University of Texas Arlington
Arlington, Texas, 76010
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9127
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-11
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-12-11
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Emotional Cognition

Additional Relevant MeSH Terms

  • Major Depressive Disorder (MDD)
  • Healthy Adult Volunteer