CompletedNot Applicable

Cognitive Enhancement in Depression (The COG-D Study)

United States16 participantsStarted 2023-02-08

Plain-language 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 episodes; either current or within past 3 years).

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 t…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in task-based fMRI activation within the Cognitive Control Network during the n-back task

Timeframe: From baseline to post-intervention (4-6 weeks)

Change in n-back behavioral performance (accuracy and response time)

Timeframe: From baseline to post-intervention (4-6 weeks)

Change in NIH Examiner scores

Timeframe: From baseline to post-intervention (4-6 weeks)

Trial details

NCT IDNCT05400512

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-18

View on ClinicalTrials.gov More Aging trials

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in task-based fMRI activation within the Cognitive Control Network during the n-back task

Timeframe: From baseline to post-intervention (4-6 weeks)

Change in n-back behavioral performance (accuracy and response time)

Timeframe: From baseline to post-intervention (4-6 weeks)

Change in NIH Examiner scores

Timeframe: From baseline to post-intervention (4-6 weeks)