Cognitive Enhancement in Recurrent Depression (The COG-D-R Study) (NCT07527273) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Cognitive Enhancement in Recurrent Depression (The COG-D-R Study)
United States69 participantsStarted 2026-09-01
Plain-language summary
The goal of this clinical trial is to learn if a combination of non-drug treatments works to benefit memory, thinking, and brain functioning in older individuals with recurrent depression. The non-drug approaches the investigators are studying include transcranial direct current stimulation (tDCS) and computerized cognitive training. tDCS uses small currents of electricity on the forehead to potentially stimulate your brain's ability to process and learn. Computerized cognitive training uses tablet games to improve memory and thinking.
In this study, two different cognitive training programs are being investigated, both of which are stimulating and designed to engage brain activity. One that is believed to be a specific treatment for depression, while the other provides extra stimulation for the brain that is non-specific. Two different tDCS parameters - active stimulation and sham (or placebo) stimulation - are also being investigated.
Participants will be randomized to one of three study groups:
1. Depression cognitive training treatment with active brain stimulation
2. Depression cognitive training treatment with sham brain stimulation
3. Non-specific cognitive training treatment with sham brain stimulation
The main questions this clinical trial aims to answer are:
* Does "depression cognitive training treatment with active brain stimulation" benefit thinking and memory more so than the other treatments?
* Does "depression cognitive training treatment with active brain stimulation" benefit brain functioning more so than the other treatments?
Participants will:
* Complete several baseline and post-intervention visits at the research center for checkups and tests over the course of 3-4 months.
* Visit the research center daily for 4 weeks to complete their assigned treatment.
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
* Evidence of executive dysfunction via SUBJECTIVE COMPLAINTS (At least one subdomain of the Behavior Rating Inventory of Executive Function in Adults (BRIEF-A) at T \> 65, or At least one average score of \> 1.5 on Planning, Organization, or Attention subdomains of the Everyday Cognition Scale (ECog)) or OBJECTIVE PERFORMANCE (At least one demographically adjusted z-score \> -1.0 SD below the mean on a measure of executive functioning (Digits backward, Trails B, or total Verbal Fluency) on the National Alzheimer's Coordinating Center (NACC) Uniform Data Set 3.0).
* DSM-5 diagnosis of a current or past (within last 3 years) depressive episode (e.g., Major Depressive Disorder (MDD), Persistent Depressive Disorder (PDD)) via the using the Structured Clinical Interview for DSM-5 Disorders (SCID-5).
* Presence of 2 or more lifetime depressive episodes to be considered "recurrent."
* Either stable antidepressant regimen for at least 6 weeks or no current antidepressant treatment (no plans to change treatment over course of study).
* Fluent in English
Exclusion Criteria:
* Other psychiatric conditions via the SCID-5 (including history of bipolar disorder and psychosis, excluding comorbid anxiety disorders)
* Severe depression (MADRS score \> 29)
* Acute suicidality on clinical evaluation by study clinician and via response on MADRS item 10 (score of 4 or more would require further assessment)
* Acute grief (occurring within past month)
* His…
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
1
NIH Examiner
Timeframe: Baseline, Following completion of the 4-week intervention, 3-month Post-Intervention
2
Resting state fMRI functional connectivity
Timeframe: Baseline, Following completion of the 4-week intervention