Recurrence Markers, Cognitive Burden and Neurobiological Homeostasis in Late-Life Depression

NCT05331599 | Active Not Recruiting

• 2 other identifiers: 2020-00781R01MH121384-01
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

Brief Summary

Late-life depression (LLD) is associated with disability, increased risk for cognitive decline and dementia, elevated suicide risk, and greater all-cause mortality. These outcomes are related to depression being a recurrent disorder, with repeated episodes over a patient's lifetime. Recurrence rates (defined as including both relapse and recurrence) are high in LLD. The goals of this study are to identify neurobiological factors that predict recurrence risk, and examine how cognitive performance changes are both influenced by these neurobiological factors and also predict recurrence risk.

Conditions

Depression in Old Age; Recurrence; Cognitive Dysfunction

Keywords

Depression in Old Age; Recurrence; Antidepressive Agents; Depression; Neurobiological Markers; Cognitive Dysfunction; Anxiety Depression

Outcome Measures

Primary Outcomes (2)

• Neurobiology of Recurrence (Stress Reactivity)

  Stress reactivity measured experimentally (neural reactivity during fMRI stress induction task) and ecologically (affective instability by ecological momentary assessment).

  Change in stress reactivity at Month 8, Month 16, and Month 24

• Neurobiology of Recurrence (Functional Network Connectivity)

  Alterations in functional network connectivity which includes both intra/internetwork connectivity markers and well as markers of network instability.

  Change in functional network connectivity at Month 8, Month 16, and Month 24

Secondary Outcomes (1)

• Change in Cognitive Function

  Change in cognitive function at Month 0 and Month 24

Study Arms (3)

Currently Depressed Participants

Individuals who are currently depressed and receive treatment through an antidepressant treatment

Remitted Depressed Participants

Individuals who have achieved remission from depression within 4 months

Remitted Depressed Elders

Individuals who no lifetime history of depression

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will enroll patients from clinical referrals and response to advertisements. For clinical referrals, referring providers may either provide information about the study to the participant, including our contact information. Alternatively, they may obtain permission from the participant for the study team to contact them. With the clinician's agreement, study staff can review their clinic schedules to help identify potentially eligible patients, however data will not be recorded for research purposes. Advertisements may include radio, newspapers, internet, online research registries, public transportation, and flyers / brochures.

You may qualify if:

• Currently depressed participants (who will enter the treatment algorithm): 1) Age \> 60 years; 2) diagnosis of major depressive disorder, recurrent episode (DSM5); 3) severity: Montgomery Asberg Depression Rating Scale (MADRS) (67) ≥ 15; 4) cognition: Montreal Cognitive Assessment (MoCA) \>24 or Montreal Cognitive Assessment (MoCA) - BLIND ≥ 18; 5) fluent in English.
• Remitted depressed participants (who will directly enter the longitudinal study): 1) Age \> 60 years; 2) diagnosis of major depressive disorder, recurrent, in partial or full remission (DSM5); 3) severity: MADRS \< 10; 4) cognition: MoCA \>24 or Montreal Cognitive Assessment (MoCA) - BLIND ≥ 18; 5) fluent in English.
• Never- depressed elders: 1) Age \> 60 years; 2) severity: MADRS \< 8; 3) cognition: MoCA \>24 or MoCA - BLIND ≥ 18; 4) fluent in English.

You may not qualify if:

• Currently depressed participants (who will enter the treatment algorithm): 1) Other Axis I psychiatric disorders, except for simple phobia or anxiety disorders present during the depressive episode (e.g., generalized anxiety disorder (GAD) or panic disorder symptoms); 2) History of alcohol or drug dependence or abuse (other than nicotine) in the last year; 3) History of a developmental disorder or history of IQ \< 70; 4) Acute suicidality within 3 months of study entry; 5) Acute grief (\<1 month); 6) Current or past psychosis; 7) Primary neurological disorder, including dementia, clinical stroke, brain tumor, epilepsy, etc.; 8) Presence of unstable medical illness requiring urgent treatment; 9) Any MRI contraindication; 10) ECT in last 6 months; 11) Vagal Nerve Stimulation within 6 months of study entry; 12) Current use of TMS, ketamine, or esketamine with plans to continue treatment.
• Never- depressed elders: Identical to the currently depressed participants, plus: 1) No diagnosis of current or past depressive disorder or other Axis I disorder except for simple phobia; 2) No history of psychotropic medication use for psychiatric symptoms.
• We will not be enrolling vulnerable populations, specifically pregnant women, children, prisoners, or institutionalized individuals. We also will not enroll subjects incapable of providing their own consent. Should a potential subject present where there is a concern (either by a study clinician or staff member) about their ability to understand study procedures and provide meaningful consent, their cognitive ability and understanding will be evaluated by a study doctor. If there is any concern that the individual may be impaired, they will not be enrolled in the study. The rationale will be provided to the individual as well as his or her family members. Referrals for further evaluation, including urgent or emergent evaluation, will be made as needed and clinically warranted.

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Pittsburgh: collaborator
• Vanderbilt University Medical Center: collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60607, United States

Location

MeSH Terms

Conditions

Recurrence; Cognitive Dysfunction; Depression

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Amruta Barve, MPH

  University of Illinois at Chicago

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor; Associate Director, Residency Training and Education; Director, Psychiatry Residency Neuroscience Research Tracks Affiliation: University of Illinois at Chicago

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 15, 2022
• Study Start: June 1, 2020
• Primary Completion: May 15, 2025
• Study Completion: January 15, 2026
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)