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

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.

Conditions

• Aging
• Depression
• Cognitive Symptoms

Interventions

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.

BEHAVIORAL

Depression Cognitive Training

Computerized cognitive training targeting the underlying cerebral networks associated with depression.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Vanderbilt University Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2028-05-30

Completion

2028-06-30

FDA Device

Yes

Countries

• United States

Study Locations