Validating the On-line Creyos Cognitive Assessment Platform in Older Adults With Major Depressive Disorder or Mild Cognitive Impairment
NCT ID: NCT06780917
Last Updated: 2025-02-24
Study Results
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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RECRUITING
150 participants
OBSERVATIONAL
2026-01-31
2029-01-31
Brief Summary
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1. To confirm the feasibility of administering the Creyos cognitive battery to older adults with Mild Cognitive Impairment MCI) or Major Depressive Disorder in remission (rMDD).
2. To determine whether the Creyos battery can detect changes in cognition that are predictive of changes on paper-and-pencil neuropsychological testing ("gold standard") over up to five years.
Participants will complete both in-person neuropsychological testing yearly as well as the Creyos online battery quarterly for up to 5 years, to allow us to compare performance on these two batteries over time.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MCI
Individuals diagnosed with Mild Cognitive Impairment
No interventions assigned to this group
Major Depressive Disorder in remission
Individuals with major depressive disorder in remission, with no active symptoms of depression
No interventions assigned to this group
Control participants
Individuals with no history of psychiatric illness, not currently taking any psychotropic medications
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Availability of a study partner who has regular contact with the participant
Exclusion Criteria
* DSM 5 diagnosis of alcohol or other substance use disorder within the past 12 months
* High risk for suicide
* Significant neurological conditions (e.g. stroke, seizure disorder, MS)
* Unstable medical illnesses (e.g. uncontrolled diabetes mellitus or hypertension)
* Taking anticonvulsants or other psychotropic medication that may interfere with cognitive testing that cannot be safely tapered and discontinued
* Current depressive symptoms defined as a MADRS score of 10 or above
Specific Eligibility Criteria for the MCI Group:
Inclusion:
* Aged 60 or older
* Meets DSM 5 criteria for Minor Neurocognitive Disorder ("MCI")
Exclusion:
* Having taken a cognitive enhancer within the past 6 weeks
Specific Eligibility Criteria for the rMDD Group:
Inclusion:
* Aged 65 or older
* Meets DSM 5 criteria for one or more major depressive episode(s) (MDE) during their adult life (i.e. 18 years of age or older) with: (a) an offset of 2 months to 5 years from the screening visit date, or (b) an offset of 5 years or more, with at least one MDE receiving medical attention (e.g. previously been on an antidepressant, saw a psychiatrist, primary care physician, or had a previous hospitalization
Exclusion:
* Having taken a cognitive enhancer within the past 6 weeks
* Having received electroconvulsive therapy (ECT) within 6 months of baseline neuropsychological testing
Specific Eligibility Criteria for the Control Group:
Inclusion:
* Aged 60 or older
Exclusion:
* Meets DSM 5 criteria for MDD at anytime during their lifetime
* Meets DSM 5 criteria for Minor Neurocognitive Disorder ("MCI")
60 Years
ALL
Yes
Sponsors
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Krembil Foundation
UNKNOWN
Centre for Addiction and Mental Health
OTHER
Responsible Party
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Benoit Mulsant
Professor, Labatt Family Chair, Department of Psychiatry, University of Toronto; Senior Scientist, Centre for Addiction and Mental Health
Locations
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Centre for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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4912
Identifier Type: -
Identifier Source: org_study_id
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