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Transcranial Electrical Stimulation
Transcranial Direct Current Stimulation for Depression
N/A
Recruiting
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Currently experiencing symptoms of depression (Patient Health Questionnaire 9, PHQ9 >4 at screening; Hamilton Depression Rating Scale 17-item, HDRS-17, score >8 at Visit 1)
Capacity to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 2 weeks, 1 month
Awards & highlights
Study Summary
This trial studies how an electrical therapy affects brain activity in people with depression. A mild current is sent between two electrodes on the scalp.
Who is the study for?
Adults aged 18-65 with a confirmed diagnosis of Major Depressive Disorder for at least one year, currently experiencing symptoms of depression, and under a stable antidepressant regimen can participate. They must be able to consent and not have any MRI contraindications like metal implants or claustrophobia.Check my eligibility
What is being tested?
The trial is testing the effects of transcranial direct current stimulation (tDCS), which involves passing mild electrical currents through the scalp, on brain function in depressed adults using fMRI imaging. Some participants will receive sham treatment as a comparison.See study design
What are the potential side effects?
Potential side effects may include discomfort at the electrode sites on the scalp, itching or tingling during stimulation, fatigue, headache, nausea or insomnia post-treatment. Serious side effects are rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am currently experiencing symptoms of depression.
Select...
I understand and can agree to the study's procedures and risks.
Select...
I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 week, 2 weeks, 1 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 2 weeks, 1 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in brain functional connectivity
Secondary outcome measures
Changes in depressive symptoms (Beck)
Changes in depressive symptoms (Hamilton)
Side effects data
From 2021 Phase 2 & 3 trial • 160 Patients • NCT024834682%
Car accident
2%
skin irritation
100%
80%
60%
40%
20%
0%
Study treatment Arm
tDCS (Active)
tDCS (Sham)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
Group II: ShamPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation
2014
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,589 Previous Clinical Trials
917,106 Total Patients Enrolled
66 Trials studying Depression
28,196 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 65 years old.You have been thinking about hurting yourself or have made plans to hurt yourself in the past month.I am currently experiencing symptoms of depression.I haven't changed my antidepressant medication in the last 6 weeks.I am currently seeing a professional for depression.I do not have any brain-affecting conditions or a significant history of substance abuse.I am not taking any medications that could affect my brain function.I was diagnosed with Major Depressive Disorder over a year ago.My antidepressant medication has not changed in the last 6 weeks.I understand and can agree to the study's procedures and risks.My gender does not affect my eligibility.I have not had any neurostimulation treatments in the last 3 months.I am 18 years old or older.I am between 18 and 65 years old.I don't have scalp conditions, hair extensions I can't remove, or metal implants.
Research Study Groups:
This trial has the following groups:- Group 1: Active
- Group 2: Sham
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For which demographic might this clinical trial be most beneficial?
"The prerequisites for inclusion in this clinical investigation are a diagnosis of depression and an age range between 18 and 65. A total of 20 participants will be admitted to the trial."
Answered by AI
Is the enrollment process open to participants at this point in time?
"Affirmative. The clinical trial registry hosted on clinicaltrials.gov confirms that recruitment for this medical study is currently underway, having been activated on July 1st 2023 and last modified on the 14th of July 2023. At present, the research team anticipates enrolling a total of twenty patients across one site location."
Answered by AI
Are geriatric individuals excluded from the parameters of this clinical research?
"This medical trial is open to patients aged 18 and over, with the upper limit for participation set at 65 years of age."
Answered by AI
How many participants are enrolled in this experiment?
"Indeed, the clinical trial is recruiting and seeking out potential candidates. This study was first listed on July 1st 2023 with a most recent update occurring two weeks later. The single medical site involved in this experiment needs to acquire twenty participants."
Answered by AI
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