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Clinical Trials/NCT05400512
NCT05400512
Completed
N/A

Non-invasive Neuromodulation to Enhance Targeted Cognitive Remediation in Older Adults With Depression

Vanderbilt University Medical Center1 site in 1 country16 target enrollmentFebruary 8, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Aging
Sponsor
Vanderbilt University Medical Center
Enrollment
16
Locations
1
Primary Endpoint
Change in NIH Examiner scores
Status
Completed
Last Updated
7 months ago

Overview

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).

Detailed Description

The purpose of this study is to determine whether the addition of active tDCS to computerized cognitive remediation (nCCR) enhances brain activity and cognitive functions in older adults with recurrent depression to a greater degree than nCCR with sham stimulation. The investigators will randomize 20 elderly depressed outpatients to either double-blinded active or sham bifrontal tDCS plus daily nCCR over 4-weeks. Multimodal MRI (focused on the cognitive control network; CCN) and psychiatric and neuropsychological evaluations will be obtained at baseline and following intervention completion. Long-term CCN cognitive effects will be explored 3-months post-intervention via cognitive assessments.

Registry
clinicaltrials.gov
Start Date
February 8, 2023
End Date
August 18, 2025
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sarah Szymkowicz

Research Instructor

Vanderbilt University Medical Center

Eligibility Criteria

Inclusion Criteria

  • 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
  • Exclusion criteria:
  • 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in NIH Examiner scores

Time Frame: From baseline to post-intervention (4-6 weeks)

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.

Secondary Outcomes

  • Change in Montgomery Asberg Depression Rating Scale (MADRS) scores)(Baseline and weekly thereafter until post-intervention (4-6 weeks))

Study Sites (1)

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