Longitudinal Observational Biomarker Study

NCT05204940 | Completed DMC

• 6 other identifiers: 080/2017R01MH114970R01MH114980R01MH114969R01MH114981R01MH114966-01
• Study Type: observational
• Target: 506
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Depression; Dementia; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Persistent Depression Leading to Change in Cognition

  To test whether persistent (non-remitting) depression has the ability to change cognition and lead to greater cognitive decline, and greater degradation of neural circuitry

  Baseline, 6-months, 24-months

Secondary Outcomes (1)

• Change in Neural Circuity

  Baseline, 6-months, 24-months

Interventions

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

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.

Neuropsychological Data BEHAVIORAL

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).

Clinical Scales BEHAVIORAL

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).

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will recruit 750 patient across all 5 sites who are 60 years or older with Major Depressive Disorder. All participants will be recruited from the OPTIMUM trial (clinicaltrials.gov identifier NCT02960763); all participants who consent and are eligible to participate in OPTIMUM will be invited to participate in this neuroimaging/neurocognitive study. Eligibility bellow will be determined and assessed as per the OPTIMUM clinical trial. In addition, they will have no contra-indications for MRI scanning.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• National Institute of Mental Health (NIMH): collaborator
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (5)

UCLA Late-Life Mood, Stress, and Wellness Research Program

Los Angeles, California, 90095, United States

Location

Washington University School of Medicine Healthy Mind Lab

St Louis, Missouri, 63110, United States

Location

Columbia University Adult and Late Life Depression Clinic

New York, New York, 10032, United States

Location

UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program

Pittsburgh, Pennsylvania, 15213, United States

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H1, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Investigators will be collecting blood biomarkers as part of their study procedures. These samples will be used to look at other factors that may relate to depression or memory and attention processes.

MeSH Terms

Conditions

Depression; Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Aristotle Voineskos, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: January 24, 2022
• Study Start: September 27, 2017
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: November 25, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will become available after all analyses and initial publication is complete.
• Access Criteria: The data will be accessible through the NIMH Data Archive (Collection ID: 2851). Please contact the principal investigators if you have further queries about access criteria.

Locations

US (4); CA (1)