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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

Must not have

Current evidence of active psychotic symptoms

History of neurological disorders (e.g., epilepsy) and/or off any treatment medication for a neurological disorder for minimum 3 years (36 months)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently experiencing symptoms of psychosis.

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I have not taken medication for a neurological disorder in the last 3 years.

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I have skin conditions or defects near where a medical device would be placed.

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I have been unconscious for over 5 minutes due to a head injury.

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I have had seizures in the past.

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I am currently experiencing a manic, hypomanic, or mixed episode of bipolar disorder.

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I experience severe discomfort or distress due to anxiety or PTSD.

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I have tried more than 6 antidepressants without success.

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I have open wounds near where the head electrodes would be placed.

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I have never been diagnosed with dementia or a major thinking/memory problem.

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I am experiencing depression due to another health condition.

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My depression did not improve after ECT, as confirmed by my doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & 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: 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

~630

0 / 15Eligibility criteria met