Status:

COMPLETED

Cognitive Enhancement in Depression (The COG-D Study)

Lead Sponsor:

Vanderbilt University Medical Center

Collaborating Sponsors:

American Academy of Neurology

Conditions:

Aging

Depression

Eligibility:

All Genders

60+ years

Phase:

NA

Brief Summary

This study will investigate whether transcranial direct current stimulation (tDCS) enhances the effects of computerized cognitive training in older adults with recurrent depression (2 or more lifetime...

Detailed Description

The purpose of this study is to determine whether the addition of active tDCS to computerized cognitive remediation (nCCR) enhances brain activity and cognitive functions in older adults with recurren...

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • Age 60+ years
  • Diagnosis of a current or past (within last 3 years) depressive episode (e.g., Major Depressive Disorder (MDD), Persistent Depressive Disorder (PDD)) using Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
  • In total, participants must have 2 or more lifetime depressive episodes to be considered "recurrent"
  • Either stable antidepressant regimen for at least 6 weeks or no current antidepressant treatment
  • Evidence of subjective cognitive complaints on the Everyday Cognition Scale (ECog)
  • English fluency
  • Exclusion criteria:
  • Other Axis I psychiatric conditions via the DSM-5, except for anxiety symptoms occurring in a depressive episode
  • Acute suicidality on clinical evaluation
  • Acute grief
  • History of alcohol use disorder or substance use disorder in last 12 months
  • Currently taking medications that would significantly interact with tDCS effects (such as sodium channel blockers or anticonvulsants)
  • Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury, Parkinson's disease)
  • Montreal Cognitive Assessment (MoCA) score \< 23
  • Primary amnestic cognitive profile (\>1.5 standard deviations (SDs) below demographically-adjusted mean on National Alzheimer's Coordinating Center (NACC) memory measures in context of otherwise normal cognitive profile)
  • Any physical or intellectual disability affecting ability to complete assessments
  • Unstable medical illness needing urgent treatment
  • MRI contraindications
  • Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in last 2 months
  • Current involvement in psychotherapy
  • Current involvement in other research studies (including but not limited to: neuromodulation \[TMS or tDCS\] or investigational drug studies)

Exclusion

    Key Trial Info

    Start Date :

    February 8 2023

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 18 2025

    Estimated Enrollment :

    16 Patients enrolled

    Trial Details

    Trial ID

    NCT05400512

    Start Date

    February 8 2023

    End Date

    August 18 2025

    Last Update

    September 16 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Vanderbilt University Medical Center

    Nashville, Tennessee, United States, 37212