NCT07527273

Cognitive Enhancement in Recurrent Depression (The COG-D-R Study)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to determine whether stepwise engagement of the frontal lobe across randomized groups (active tDCS+depression cognitive training \> sham tDCS+depression cognitive training \> sham tDCS+non-specific cognitive training) will result in progressively greater improvements in executive functions and memory, as well as intrinsic functional connectivity of the Executive Control Network (ECN), in older adults with recurrent depression. The investigators will randomize 69 elderly depressed outpatients into one of three conditions daily over 4-weeks. Psychiatric and neuropsychological evaluations, as well as multimodal neuroimaging (focused on the ECN) will be obtained at baseline and following intervention completion to look at acute and long-term effects.

Conditions

• Aging
• Depression
• Cognitive Symptoms

Interventions

Type	Name	Description
BEHAVIORAL	Depression Cognitive Training	Computerized cognitive training targeting the underlying cerebral networks associated with depression.
BEHAVIORAL	Non-Specific Cognitive Training	Computerized cognitive training that provides extra stimulation for the brain that is non-specific.
DEVICE	tDCS (active stimulation)	A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0 milliamps (mA) direct current through two bicarbon rubber electrodes encased in saline soaked 5 cm x 7 cm sponges (8 cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (via 10-20 system).
DEVICE	tDCS (sham stimulation)	Sham stimulation will be performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-05-30
• Completion: 2028-06-30
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study