tDCS for Treatment-Resistant Depression

Recruiting in Palo Alto (17 mi)

Overseen byCharles Conway, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Washington University School of Medicine

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

This pilot study aims to investigate the potential role of transcranial direct current stimulation (tDCS) in the treatment of treatment-resistant major depressive disorder (MDD). tDCS is a noninvasive brain stimulation technique which has been utilized for the treatment of major depression in several studies, both as a primary and adjunctive treatment. The treatment will be administered under the supervision of a physician with experience in administering the treatment and monitoring for complications. This will be a prospective "adaptive tDCS stimulation" open label research study. Participants will receive 20 minute sessions of up to 4 milliamps (mA) transcutaneous electrical stimulation sessions over 4 to 6 weeks. Building on the theory that greater current "dose" may be a significant factor in determining efficacy, this study aims to determine whether higher tDCS current doses lead to greater improvements in depressive symptoms in this population of patients with treatment-resistant major depressive disorder.

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 65 years old.

I have been diagnosed with major depressive disorder and currently have symptoms.

Baseline score of Hamilton Depression Rating Scale 17-item (HDRS-17) score of 17 or higher

See 2 more

Exclusion 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.

See 21 more

Treatment Details

Interventions

tDCS (Brain Stimulation)

Trial OverviewThe 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.

Participant Groups

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.