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

NCT ID: NCT05331599

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

210 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2026-01-15

Brief Summary

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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.

Detailed Description

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Conditions

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Depression in Old Age Recurrence Cognitive Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Currently Depressed Participants

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

No interventions assigned to this group

Remitted Depressed Participants

Individuals who have achieved remission from depression within 4 months

No interventions assigned to this group

Remitted Depressed Elders

Individuals who no lifetime history of depression

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* Remitted depressed participants (who will directly enter the longitudinal study): Identical to the currently depressed participants, plus 1) currently receiving brain stimulation treatment (ECT, TMS, VNS), ketamine or esketamine. There are no other exclusions for antidepressant 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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

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Olusola Alade Ajilore

Associate Professor; Associate Director, Residency Training and Education; Director, Psychiatry Residency Neuroscience Research Tracks Affiliation: University of Illinois at Chicago

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amruta Barve, MPH

Role: STUDY_CHAIR

University of Illinois at Chicago

Locations

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University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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1R01MH121384-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020-0078

Identifier Type: -

Identifier Source: org_study_id

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