Back to Trials
NCT07042217NARecruiting

Transcranial Direct Current Stimulation for Depression

Soterix Medical

Start Date

7/1/2025

Completion Date

9/1/2026

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 Criteria

Age Range: 22 years to No maximum

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 * Pregnancy

Interventions

DEVICE

transcranial direct current stimulation (tDCS) and mindfulness instruction

DEVICE

Sham tDCS and Mindfulness

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Unipolar Depression

Locations

Soterix Medical, Inc.

Woodbridge, New Jersey 07095

United States