Cognitive Enhancement in Depression (The COG-D Study)
Non-invasive Neuromodulation to Enhance Targeted Cognitive Remediation in Older Adults With Depression
1 other identifier
interventional
16
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 27, 2022
CompletedFirst Posted
Study publicly available on registry
June 1, 2022
CompletedStudy Start
First participant enrolled
February 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 18, 2025
CompletedSeptember 16, 2025
September 1, 2025
2.5 years
May 27, 2022
September 15, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in NIH Examiner scores
This cognitive test battery assesses a range of executive functions (working memory, inhibition, set shifting, fluency, insight, and planning). The investigators will examine its Executive Composite Score, with higher scores indicate better performance.
From baseline to post-intervention (4-6 weeks)
Secondary Outcomes (1)
Change in Montgomery Asberg Depression Rating Scale (MADRS) scores)
Baseline and weekly thereafter until post-intervention (4-6 weeks)
Study Arms (2)
Cognitive Training + Active Stimulation
EXPERIMENTALThis arm receives cognitive training combined with active tDCS.
Cognitive Training + Sham Stimulation
EXPERIMENTALThis arm receives cognitive training combined with sham tDCS.
Interventions
Computerized cognitive training targeting the underlying cerebral networks associated with depression.
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah M. Szymkowicz, PhD
Vanderbilt University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Instructor
Study Record Dates
First Submitted
May 27, 2022
First Posted
June 1, 2022
Study Start
February 8, 2023
Primary Completion
August 18, 2025
Study Completion
August 18, 2025
Last Updated
September 16, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share