AgingNCT07527273
Cognitive Enhancement in Recurrent Depression (The COG-D-R Study)
A study testing Depression Cognitive Training, Non-Specific Cognitive Training and tDCS (active stimulation) in people with Aging and Depression, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging, Depression, Cognitive Symptoms
- What is being tested?
- Depression Cognitive Training, Non-Specific Cognitive Training and tDCS (active stimulation)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- History of alcohol use disorder or substance use disorder of moderate or greater severity in the last 12 months
- Medications that would significantly interfere with tDCS effects (i.e., sodium channel blockers, GABA-ergic or glutamatergic drugs; see Appendix B for exclusionary list)40
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- Primary neurological disorder (e.g., epilepsy, brain tumor, Parkinson's disease, Alzheimer's disease, dementia diagnosis)
- Montreal Cognitive Assessment (MoCA) < 23
- Primary amnestic cognitive profile (>1.5 SD below demographically-adjusted mean on NACC memory measures in context otherwise normal cognitive profile, or per clinician judgement)
- 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). Observational studies [without intervention] are acceptable.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
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.
Read more
Participants will be randomized to one of three study groups:
- Depression cognitive training treatment with active brain stimulation
- Depression cognitive training treatment with sham brain stimulation
- 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.
Read the 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
- Being tested
- Depression Cognitive Training, Non-Specific Cognitive Training, tDCS (active stimulation), tDCS (sham stimulation)
- Keywords
- geriatrics, aging, elderly, cognition, memory, thinking, depression, tDCS, cognitive training, cognitive remediation, digital therapeutics
- Medical subject headings
- Depression, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depression Cognitive TrainingBehavioural
Computerized cognitive training targeting the underlying cerebral networks associated with depression.
Non-Specific Cognitive TrainingBehavioural
Computerized cognitive training that provides extra stimulation for the brain that is non-specific.
tDCS (active stimulation)Device
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).
tDCS (sham stimulation)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Depression Cognitive Training + Active Stimulation | Experimental | This arm receives the depression cognitive training combined with active tDCS. Receives: Behavioral: Depression Cognitive Training; Device: tDCS (active stimulation) |
| Depression Cognitive Training + Sham Stimulation | Experimental | This arm receives the depression cognitive training combined with sham tDCS. Receives: Behavioral: Depression Cognitive Training; Device: tDCS (sham stimulation) |
| Non-Specific Cognitive Training + Sham Stimulation | Experimental | This arm receives the non-specific cognitive training combined with sham tDCS. Receives: Behavioral: Non-Specific Cognitive Training; Device: tDCS (sham stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIH Examiner
This objective cognitive test battery assesses a range of executive functions (working memory, inhibition, set shifting, fluency, and planning). The investigators will examine intervention-related change its Executive Composite Score (primary outcome), and subcomposite (Cognitive Control, Working Memory, and Fluency; secondary outcomes) scores, where higher scores indicate better performance.
Measured: Baseline, Following completion of the 4-week intervention, 3-month Post-Intervention
Resting state fMRI functional connectivity
Functional connectivity from resting state fMRI will be processed using the CONN toolbox for connectivity, incorporating the Shaeffer network atlases to improve peer-research supported network usage in addition to the standard CONN atlases. A priori ROI-to-ROI analyses will be used to determine whether average connectivity changes in the Executive Control Network differs by treatment group. Analyses will control for multiple comparisons at false discovery rate (FDR) < 0.05.
Measured: Baseline, Following completion of the 4-week intervention
Secondary outcomes (1)
Montgomery Asberg Depression Rating Scale
The MADRS is a 10-item clinician-rated measure of depression severity, with higher scores indicating greater symptom severity. We will look at change in depression severity over the course of the intervention by treatment arm in Exploratory Analyses.
Measured: Baseline and weekly thereafter, Following completion of the 4-week intervention, 3-Month Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 May 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sarah Szymkowicz, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527273
- Sponsor's protocol ID
- 251809
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Enhancement in Recurrent Depression (The COG-D-R Study)
- ClinicalTrials.gov ID
- NCT07527273
- Acronym / sponsor ID
- 251809
- Conditions
- Aging, Depression, Cognitive Symptoms
- Keywords
- geriatrics, aging, elderly, cognition, memory, thinking, depression, tDCS
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Depression cognitive training treatment with active brain stimulation
- Depression cognitive training treatment with sham brain stimulation
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Depression Cognitive Training + Active Stimulation | Experimental | Behavioral: Depression Cognitive Training, Device: tDCS (active stimulation)This arm receives the depression cognitive training combined with active tDCS. |
| Depression Cognitive Training + Sham Stimulation | Experimental | Behavioral: Depression Cognitive Training, Device: tDCS (sham stimulation)This arm receives the depression cognitive training combined with sham tDCS. |
| Non-Specific Cognitive Training + Sham Stimulation | Experimental | Behavioral: Non-Specific Cognitive Training, Device: tDCS (sham stimulation)This arm receives the non-specific cognitive training combined with sham tDCS. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (15 listed)
- 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)
- History of alcohol use disorder or substance use disorder of moderate or greater severity in the last 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Depression Cognitive TrainingComputerized cognitive training targeting the underlying cerebral networks associated with depression. | Behavioural | Depression Cognitive Training + Active Stimulation, Depression Cognitive Training + Sham Stimulation |
| Non-Specific Cognitive TrainingComputerized cognitive training that provides extra stimulation for the brain that is non-specific. | Behavioural | Non-Specific Cognitive Training + Sham Stimulation |
| 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 | Depression Cognitive Training + Active Stimulation |
| 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. | Device | Depression Cognitive Training + Sham Stimulation, Non-Specific Cognitive Training + Sham Stimulation |
Primary outcome
NIH Examiner
Time frame: Baseline, Following completion of the 4-week intervention, 3-month Post-Intervention
This objective cognitive test battery assesses a range of executive functions (working memory, inhibition, set shifting, fluency, and planning). The investigators will examine intervention-related change its Executive Composite Score (primary outcome), and subcomposite (Cognitive Control, Working Memory, and Fluency; secondary outcomes) scores, where higher scores indicate better performance.
Resting state fMRI functional connectivity
Time frame: Baseline, Following completion of the 4-week intervention
Functional connectivity from resting state fMRI will be processed using the CONN toolbox for connectivity, incorporating the Shaeffer network atlases to improve peer-research supported network usage in addition to the standard CONN atlases. A priori ROI-to-ROI analyses will be used to determine whether average connectivity changes in the Executive Control Network differs by treatment group. Analyses will control for multiple comparisons at false discovery rate (FDR) < 0.05.
1 secondary outcome
Montgomery Asberg Depression Rating Scale
Time frame: Baseline and weekly thereafter, Following completion of the 4-week intervention, 3-Month Post-Intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Depression Cognitive Training, Non-Specific Cognitive Training and tDCS (active stimulation) in people with Aging and Depression, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Szymkowicz, PhD (615-875-0032, sarah.szymkowicz@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIH Examiner (time frame: Baseline, Following completion of the 4-week intervention, 3-month Post-Intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.