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tDCS interventional arm for Major Depressive Disorder

N/A

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 below

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability outcome

Feasibility outcome

Tolerability outcome

Secondary outcome measures

Change in Digital Symbol Coding Test (DSCT)

Change in Montgomery-Asberg Depression Rating Scale (MADRS)

Change in Peak alpha frequency (PAF)

+3 more

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

~640

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,207 Previous Clinical Trials

3,766,850 Total Patients Enrolled

Maria I Lapid, MDPrincipal InvestigatorMayo Clinic

2 Previous Clinical Trials

71 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there ongoing efforts to enlist individuals for participation in this current research study?

"Apologies for the misunderstanding. According to the details provided on clinicaltrials.gov, this study is not currently accepting new participants. The trial was originally posted on March 1st, 2024 and last updated on January 24th, 2024. However, it's worth noting that there are currently 1356 other trials actively recruiting participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD)

Maria I. Lapid, M.D. 2024. "Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06236711.

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