Actively Recruiting

Phase Not Applicable
Age: 22Years +
All Genders
NCT07042217

Transcranial Direct Current Stimulation for Depression

Led by Soterix Medical · Updated on 2025-11-10

25

Participants Needed

1

Research Sites

61 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Transcranial Direct Current Stimulation for Depression

Who Can Participate

Age: 22Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinically stable patients diagnosed with major depressive disorder (MDD) according to DSM-V-TR confirmed with Mini International Neuropsychiatric interview
  • Currently experiencing a major depressive episode lasting at least 4 weeks as part of unipolar depression
  • QIDS-SR score greater than 11 on all three screening days (Days 1, 3, 7)
  • Score of at least 17 on the HDRS-17 depression scale at trial entry
  • Stable antidepressant medication for at least 30 days prior to HDRS-17 screening
  • Female participants must not be pregnant and use medically acceptable contraception if of childbearing potential
Not Eligible

You will not qualify if you...

  • Failure to respond to at least 2 antidepressant medications
  • Drug or alcohol abuse or dependence within the past 3 months
  • Current use of benzodiazepine medication
  • High suicide risk assessed at baseline
  • Failure to respond to electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) in this or any previous episode
  • Current psychotic disorder according to DSM-V-TR
  • History of neurological disorder or injury affecting study participation as determined by study physician
  • Presence of metal in skull or skull defects
  • Implanted devices such as pump, neurostimulator, pacemaker, or defibrillator
  • Skin lesions on the scalp at electrode sites
  • Pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Soterix Medical, Inc.

Woodbridge, New Jersey, United States, 07095

Actively Recruiting

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Research Team

P

Paul Thomas Researcher

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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