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Cognitive Training + tDCS for Depression
N/A
Recruiting
Led By Sarah M. Szymkowicz, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Depression severity of 15+ on the MADRS
Age 60+ years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to post-intervention (4-6 weeks)
Awards & highlights
Study Summary
This trial will investigate whether tDCS, a noninvasive brain stimulation technique, can enhance the effects of cognitive training in older adults with depression.
Who is the study for?
This trial is for adults aged 60 and over who have been diagnosed with Major Depressive Disorder, as per DSM-5 criteria. They should be experiencing cognitive complaints and a depression severity of 15+ on the MADRS scale. Participants must speak English fluently and either be on a stable antidepressant regimen for at least six weeks or not taking any antidepressants.Check my eligibility
What is being tested?
The study examines if transcranial direct current stimulation (tDCS), which uses mild electrical currents applied to the head, can improve cognitive function when combined with cognitive training in older adults suffering from depression.See study design
What are the potential side effects?
Potential side effects of tDCS may include discomfort at the electrode site, itching, tingling, headache, fatigue, and in rare cases mood changes. Sham stimulation is used as a control and typically has no active side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My depression is severe, scoring 15 or more on a scale.
Select...
I am 60 years old or older.
Select...
I have been diagnosed with Major Depressive Disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to post-intervention (4-6 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to post-intervention (4-6 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in NIH Examiner scores
Secondary outcome measures
Change in Montgomery Asberg Depression Rating Scale (MADRS) scores)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cognitive Training + Sham StimulationExperimental Treatment2 Interventions
This arm receives cognitive training combined with sham tDCS.
Group II: Cognitive Training + Active StimulationExperimental Treatment2 Interventions
This arm receives cognitive training combined with active tDCS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Training
2008
Completed Phase 3
~4100
tDCS (sham stimulation)
2017
N/A
~380
tDCS (active stimulation)
2017
N/A
~380
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,172 Total Patients Enrolled
16 Trials studying Depression
894 Patients Enrolled for Depression
American Academy of NeurologyOTHER
11 Previous Clinical Trials
322 Total Patients Enrolled
1 Trials studying Depression
Sarah M. Szymkowicz, PhDPrincipal InvestigatorVanderbilt University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a significant memory problem compared to other people your age, even though your overall thinking skills seem normal.You have reported problems with memory and thinking on a specific questionnaire.My depression is severe, scoring 15 or more on a scale.I have a neurological disorder such as dementia, stroke, or Parkinson's.I am not on medication that affects brain stimulation treatments.I have been on the same antidepressant for at least 6 weeks or am not taking any.I do not have disabilities that affect my ability to complete health assessments.I am 60 years old or older.You have been recently evaluated and found to be at risk of harming yourself.My memory and thinking test score is below 23.I may have anxiety, but it's part of my depression.I haven't had ECT or TMS in the last 2 months.I do not have any urgent medical conditions needing immediate treatment.I am currently in psychotherapy.I have been diagnosed with Major Depressive Disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Cognitive Training + Sham Stimulation
- Group 2: Cognitive Training + Active Stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT05400512 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies available for participation in this trial?
"Data hosted on clinicaltrials.gov suggests that this medical experiment is not presently recruiting any subjects. Initially posted on November 1st 2022, the last update was done at the end of September in 222. However, there are over 1500 other trials currently searching for participants to partake in them."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Vanderbilt University Medical Center
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have previously tried so many different medications that I can’t remember an exact count anymore and am currently not using any treatment for my depression but am interested in trying new options.
PatientReceived 1 prior treatment
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