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Transcranial Direct Current Stimulation for Depression | Clinical Trials | Clareo Health

RECRUITINGNA

Transcranial Direct Current Stimulation for Depression

A Randomized, Double-blind, Parallel-arm, Sham-controlled Trial of ElectraRx Mindfulness Transcranial Direct Current Treatment System (Elect-MDS) for Adults With Major Depressive Disorder

NCT07042217•Soterix Medical

View on ClinicalTrials.gov

Summary

This study will test the efficacy of transcranial direct current stimulation (tDCS) combined with mindfulness, remotely-delivered using a telemedicine protocol in 25 adults with unipolar depression.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Clinically stable patients that meet criteria for diagnosis of MDD according to DSM-V-TR and confirmed with the Mini International Neuropsychiatric interview
•Currently experiencing a major depressive episode of at least 4 week's duration as part of a unipolar depression
•QIDS-SR score \>11 on all three days of screening week (Days 1,3, 7)
•Scored at least 17 (inclusive) on the HDRS-17 at trial entry
•Any antidepressant medication is stable ≥ 30 days prior to HDRS-17 screening
•Female patients are allowed if not pregnant and using a medically acceptable method of contraception, if of childbearing potential.

Exclusion Criteria

•Failure to respond to at least 2 antidepressant medications
•Drug or alcohol abuse or dependence in the preceding 3 months
•Concurrent benzodiazepine medication
•High suicide risk assessed during clinician screening at baseline interview.
•Failure to respond to ECT treatment or rTMS treatment in this or any previous episode.
•Current DSM-V-TR psychotic disorder
•History of clinically defined neurological disorder or insult that may impact participation in this study as determined by study physician
•Metal in the cranium or skull defects
•Implanted pump, neurostimulator, cardiac pacemaker or defibrillator
•Skin lesions on scalp at the proposed electrode sites
+1 more criteria

Locations (1)

Soterix Medical, Inc.

Woodbridge, New Jersey, United States

Key Dates

Start Date

July 1, 2025

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

November 10, 2025

Enrollment

ESTIMATED participants

Conditions

Unipolar Depression

Interventions

transcranial direct current stimulation (tDCS) and mindfulness instruction

DEVICE

Sham tDCS and Mindfulness

DEVICE

Contacts

Paul Thomas Researcher

CONTACT

18889908327 trials@soterixmedical.com

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Transcranial Direct Current Stimulation for Depression

Inclusion Criteria

Exclusion Criteria

Effect of Intermittent and Continuous Theta Burst Stimulation on Sleep, Daytime Sleepiness, and Fatigue in Depression

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