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tDCS for Depression
N/A
Recruiting
Led By Maria I Lapid, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years and older
Moderate or severe depression, defined by PHQ-9 ≥ 15
Must not have
Any active neurological condition (including seizure disorder, traumatic brain injury, stroke)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if using a treatment called transcranial Direct Current Stimulation (tDCS) is possible and acceptable for adult patients with Treatment Resistant Depression (TRD). The researchers
Who is the study for?
This trial is for adults hospitalized with Treatment Resistant Depression (TRD), which means their depression hasn't improved after trying at least two different treatments. Participants should be able to give informed consent and follow the study procedures.
What is being tested?
The study is testing transcranial Direct Current Stimulation (tDCS) as an additional treatment for TRD. It aims to see if tDCS is a feasible and acceptable option, whether it can improve depressive symptoms and thinking processes, and if certain biomarkers can predict how well someone will respond to this therapy.
What are the potential side effects?
Possible side effects of tDCS may include mild discomfort or itching under the electrode, headache, fatigue, nausea or dizziness. These are generally mild and temporary but vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have moderate to severe depression.
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My depression hasn't improved after trying two or more treatments for at least 4 weeks each.
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I have been hospitalized in a psychiatric unit.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have an active neurological condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability outcome
Feasibility outcome
Tolerability outcome
Secondary study objectives
Change in Digital Symbol Coding Test (DSCT)
Change in Montgomery-Asberg Depression Rating Scale (MADRS)
Change in Peak alpha frequency (PAF)
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: tDCS interventional armExperimental Treatment1 Intervention
Participants will receive a 30-minute tDCS treatments at 2 mA twice daily over the course of 5 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tDCS
2017
Completed Phase 2
~630
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,360 Previous Clinical Trials
3,065,931 Total Patients Enrolled
Maria I Lapid, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
71 Total Patients Enrolled