Adaptive tDCS for Treatment-Resistant MDD

NCT02942368 | Terminated Phase 1 FDA Device

• 1 other identifier: 6610-201610133
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Improvement in depressive symptoms as measured by mean change in the Montgomery-Åsberg Depression Rating Scale (MADRS) score from baseline to end of the study.

  Measurements at week 0, week 2, week 4, week 5 and week 6

Study Arms (1)

tDCS

EXPERIMENTAL

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. Anodal placement will be over the left dorsolateral prefrontal cortex region of the head, and cathodal stimulation over the right temporal region, as has been demonstrated in other studies of tDCS for depression. Treatments will take place daily, 5 days per week. This study will allow tDCS stimulation to be customized for each individual participant and their different threshold for pain.

Device: tDCS

Interventions

tDCS DEVICE

Transcranial direct current stimulation with placement of the anode over the F3 region of the scalp and the cathode over the right supraorbital region.

tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age 18 to 65
• History of major depressive disorder with current depressive symptoms, as defined by DSM-IV criteria
• Baseline score of Hamilton Depression Rating Scale 17-item (HDRS-17) score of 17 or higher
• Failure of at least 3 prior lifetime antidepressant trials
• Good command of the English language

You may not qualify if:

• Lifetime history of the following, defined by DSM-IV criteria per study physician:
• Moderate or severe substance use disorder in the past 6 months with the exception of nicotine use disorder
• Dementia or major neurocognitive disorder
• Schizophrenia spectrum disorders
• Autism spectrum disorder
• Depression which has failed to respond to ECT, with treatment failure as determined by evaluating physician
• Failure of greater than 6 antidepressant trials in the current depressive episode
• Current evidence of the following, defined by present symptomology as per study physician:
• Active psychotic symptoms
• Bipolar disorder with a current manic, hypomanic, or mixed episode as defined by DSM-IV criteria
• Depression secondary to a general medical illness
• Dysphoria better explained by a personality disorder
• Dysphoria associated with a primary anxiety disorder or PTSD
• Active suicidal intention (inability to contract for safety)
• Any change in psychotropic medication within 30 days of the initiation of tDCS

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Charles Conway, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Outcomes assessors are blinded and unaware of the specifics of the study (although only a single arm, blinded raters do not know this).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a prospective "adaptive tDCS stimulation" single-blind research study (patients and those delivering tDCS will be unblinded, raters will be blinded of design).

Study Record Dates

• First Submitted: October 21, 2016
• First Posted: October 24, 2016
• Study Start: April 14, 2017
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)