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Brain Stimulation
tDCS for Treatment-Resistant Depression
N/A
Waitlist Available
Led By Charles Conway, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults age 18 to 65
History of major depressive disorder with current depressive symptoms, as defined by DSM-IV criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measurements at week 0, week 2, week 4, week 5 and week 6
Awards & highlights
Study Summary
This trial is testing whether a noninvasive brain stimulation technique called transcranial direct current stimulation (tDCS) can help treat major depressive disorder that has not responded to other treatments. tDCS involves passing a small electrical current through the brain to stimulate nerve cells. The trial will test different "doses" of tDCS (amount of current passed through the brain) to see if higher doses lead to greater improvements in depressive symptoms.
Who is the study for?
This trial is for adults aged 18-65 with treatment-resistant major depressive disorder, as indicated by a failure of at least three antidepressant trials and a Hamilton Depression Rating Scale score of 17 or higher. Participants must speak English well but cannot join if they have certain mental health conditions, recent medication changes, neurological disorders, skin issues where electrodes are placed, metal implants in the head, severe head injuries, chronic headaches or seizures.Check my eligibility
What is being tested?
The study tests whether higher doses of transcranial direct current stimulation (tDCS), up to 4 milliamps over sessions lasting 20 minutes each for 4-6 weeks can improve symptoms in patients with treatment-resistant depression. It's an open-label study meaning everyone knows what treatment is being given.See study design
What are the potential side effects?
Potential side effects from tDCS may include discomfort at the electrode sites on the scalp, headache, fatigue, nausea or itching under the electrode pads. More serious risks could involve seizures or mood swings although these are considered rare.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
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I have been diagnosed with major depressive disorder and currently have symptoms.
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I have tried at least 3 different antidepressants without success.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measurements at week 0, week 2, week 4, week 5 and week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measurements at week 0, week 2, week 4, week 5 and week 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement in depressive symptoms as measured by mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to end of the study.
Trial Design
1Treatment groups
Experimental Treatment
Group I: tDCSExperimental Treatment1 Intervention
Patients will receive transcranial direct current stimulation using an adaptive protocol allowing for doses of 0 to 4 mA during the course of the treatment, with twenty 20-minute sessions over the course of 4 to 6 weeks. Treatments will take place daily, 5 days per week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tDCS
2017
Completed Phase 2
~640
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,684 Total Patients Enrolled
68 Trials studying Depression
23,354 Patients Enrolled for Depression
Charles Conway, MDPrincipal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
7,998 Total Patients Enrolled
4 Trials studying Depression
1,198 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently experiencing symptoms of psychosis.I have not taken medication for a neurological disorder in the last 3 years.I have a history of chronic headaches or migraines.My headaches or migraines have changed in the last two weeks.I haven't changed my mental health medication in the last 30 days.I have skin conditions or defects near where a medical device would be placed.I have been unconscious for over 5 minutes due to a head injury.I am between 18 and 65 years old.I have been diagnosed with major depressive disorder and currently have symptoms.I have had seizures in the past.I am currently experiencing a manic, hypomanic, or mixed episode of bipolar disorder.I experience severe discomfort or distress due to anxiety or PTSD.I have tried more than 6 antidepressants without success.I have open wounds near where the head electrodes would be placed.I have never been diagnosed with dementia or a major thinking/memory problem.I am experiencing depression due to another health condition.I have tried at least 3 different antidepressants without success.My depression did not improve after ECT, as confirmed by my doctor.
Research Study Groups:
This trial has the following groups:- Group 1: tDCS
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible to partake in this clinical experiment?
"This clinical trial is accepting 25 patients aged 18 to 65 suffering from treatment-resistant depression. To be eligible, each person must have a HDRS-17 score of 17 or above at the baseline assessment."
Answered by AI
Are there available vacancies in this research project for participants?
"The data on clinicaltrials.gov affirms that this specific medical investigation, which was established in April 2017 and last updated in July 2022, is currently not enrolling patients. However, there are over a thousand other trials actively seeking participants right now."
Answered by AI
Does this trial welcome participants who are aged 50 or older?
"To be enrolled in this clinical trial, participants must meet the age criteria of being over 18 and below 65 years old."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
How old are they?
18 - 65
What site did they apply to?
Washington University in Saint Louis
What portion of applicants met pre-screening criteria?
Met criteria
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