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Longitudinal Observational Biomarker Study

Neurocognitive and Neuroimaging Biomarkers: Predicting Progression Towards Dementia in Patients With Treatment-resistant Late-life Depression (OPTIMUM-Neuro Study)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05204940
Acronym
OPT-Neuro
Enrollment
506
Registered
2022-01-24
Start date
2017-09-27
Completion date
2024-07-31
Last updated
2024-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Dementia, Mild Cognitive Impairment

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.

Detailed description

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.

Interventions

BEHAVIORALMechanisms 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.

BEHAVIORALNeuropsychological 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).

BEHAVIORALClinical 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).

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Centre for Addiction and Mental Health
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Persistent Depression Leading to Change in CognitionBaseline, 6-months, 24-monthsTo test whether persistent (non-remitting) depression has the ability to change cognition and lead to greater cognitive decline, and greater degradation of neural circuitry

Secondary

MeasureTime frameDescription
Change in Neural CircuityBaseline, 6-months, 24-monthsTo test whether greater degradation of neural circuitry is associated with greater cognitive decline

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026