NCT02942368

Adaptive tDCS for Treatment-Resistant MDD

Adaptive Transcranial Direct Current Stimulation as an Adjunctive Therapy for Treatment-Resistant Major Depressive Disorder

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Depressive Disorder, Treatment-Resistant

Interventions

Type	Name	Description
DEVICE	tDCS	Transcranial direct current stimulation with placement of the anode over the F3 region of the scalp and the cathode over the right supraorbital region.

Timeline

• Start date: 2017-04-14
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2016-10-24
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study