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CompletedNCT05204940OPT-NeuroUpdated Nov 25, 2024

Longitudinal Observational Biomarker Study

An observational study in Depression, Dementia and Mild Cognitive Impairment, sponsored by Centre for Addiction and Mental Health. Completed at 5 sites in 2 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-11-25.

Sponsored by Centre for Addiction and Mental Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
506
Ages
60 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Depression
  • Dementia
  • Mild Cognitive Impairment
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In context

Dementia

2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.

This study's enrollment of 506 is above the median of 250 across 482 observational studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Centre for Addiction and Mental Health is the lead sponsor of 327 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
506 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

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).

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What researchers measure

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

    Time frame: Baseline, 6-months, 24-months

Secondary outcomes

  1. Change in Neural Circuity

    To test whether greater degradation of neural circuitry is associated with greater cognitive decline

    Time frame: Baseline, 6-months, 24-months

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Study locations

5 sites
  • UCLA Late-Life Mood, Stress, and Wellness Research Program
    Los Angeles, California 90095, United States
  • Washington University School of Medicine Healthy Mind Lab
    Saint Louis, Missouri 63110, United States
  • Columbia University Adult and Late Life Depression Clinic
    New York, New York 10032, United States
  • UPMC Late-Life Depression, Evaluation, Prevention, and Treatment Program
    Pittsburgh, Pennsylvania 15213, United States
  • Centre for Addiction and Mental Health
    Toronto, Ontario M6J 1H1, Canada
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References and documents

Individual participant data

Plan to share: Yes — A cleaned, complete, and de-identified copy of the final data set including administrative and technical metadata records will be made available on the National Institute of Mental Health (NIMH) Data Archive and registered at clinicaltrials.gov.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05204940
Lead sponsor
Centre for Addiction and Mental Health
Collaborators
National Institute of Mental Health (NIMH), Patient-Centered Outcomes Research Institute
Responsible party
Sponsor
First posted
Jan 24, 2022
Start date
Sep 27, 2017
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024
Last update
Nov 25, 2024

Study contacts

Aristotle Voineskos, MD
principal investigator · Centre for Addiction and Mental Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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