Longitudinal Observational Biomarker Study

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

COMPLETED

Total Enrollment

506 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-27

Study Completion Date

2024-07-31

Brief Summary

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The purpose of this study is to test whether treatment-resistant late life depression is associated with declines in memory and attention and brain structure and function.

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Detailed Description

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The purpose of this study is to test whether treatment-resistant late life depression is associated with declines in memory and attention and brain structure and function. The study will also test if changes in brain structure and function are associated with decreases in memory. In this study, investigators will conduct a series of assessments/tests, mainly brain imaging and assessments of participant's memory and attention, to better understand how depression is linked to memory and thinking in older persons. Investigators hope that their study will help the scientific community to understand why some people with depressive symptoms that are resistant to treatment in late-life experience declines in their memory and attention and whether effective treatment of such depression reduces that risk. Finally, investigators hope that this study will eventually lead to the development of better treatment options.

Conditions

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Depression Dementia Mild Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Mechanisms of Late life depression (LLD)-dementia through functional Magnetic Resonance Imaging (fMRI)

Analyzing mechanisms of the LLD-dementia relationship through fMRI acquisitions and analyses, to capture the specific brain networks implicated in executive function and episodic memory decline.

Intervention Type BEHAVIORAL

Neuropsychological Data

Neuropsychological Data, including Montreal Cognitive Assessment (MoCA), Wide Range Achievement Test-4 (WRAT-4) Reading subtest, Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Delis-Kaplan Executive Function System (D-KEFS) (Color Word Interference, Trail Making and Verbal Fluency).

Intervention Type BEHAVIORAL

Clinical Scales

Clinical scales, including the Everyday Cognition Scale (E-Cog), Global Clinical Dementia Rating (CDR), Performance Assessment of Selfcare Skills (PASS)--CIADL (Cognitive Instrumental Activities of Daily Living) Short version, Patient Health Questionnaire (PHQ-9), and Suicide Risk Assessments (Suicide Questions, Baseline Suicidal Ideation, Suicide Intent Scale, Beck Lethality Scale, Decision Outcome Inventory, Columbia-Suicide Severity Rating Scale, and High Suicide Risk Protocol).

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Men and women aged 60 and older
* Current Major Depressive Disorder (MDD)
* Failure to respond adequately to two or more antidepressant treatment trials of recommended dose and length
* Patient Health Questionnaire-9 (PHQ-9) score of 10 or higher

Exclusion Criteria

* Dementia
* Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
* High risk for suicide and unable to be managed safely in the clinical trial
* Non-correctable, clinically significant sensory impairment interfering with participation
* Unstable medical illness, including delirium, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management.
* Moderate to severe substance or alcohol use disorder
* Seizure disorder.
* Parkinson's Disease
* Individuals with any contraindications to MRI

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No