Recruiting

tDCS & Mindfulness

Sponsor:

Soterix Medical

Code:

NCT07042217

Conditions

Unipolar Depression

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

transcranial direct current stimulation (tDCS) and mindfulness instruction

Sham tDCS and Mindfulness

Study Details

Brief 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.

Conditions

Unipolar Depression

Study ID

NCT07042217

Start date

Jul 1, 2025

Status verified date

Oct, 2025

Completion date

Sep 1, 2026

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active tDCS and Mindfulness

Application of electrical stimulation to the brain non-invasively combined with mindfulness

sham comparator: Sham tDCS and Mindfulness

Sham electrical stimulation and mindfulness

Interventions

transcranial direct current stimulation (tDCS) and mindfulness instruction

tDCS together with audio providing mindfulness instruction and music

Sham tDCS and Mindfulness

Placebo electrical sitmulation and audio-guided mindfulness instruction

Primary outcome measure

  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: Week 4 and Week 7 ]
  • Blinding Integrity [ Time Frame: Week 7 ]

Central Contacts and Locations

Central contacts

Paul Thomas Researcher

18889908327trials@soterixmedical.com

Locations

Soterix Medical, Inc.

Recruiting

Woodbridge, New Jersey, United States, 07095

Contacts

Paul Thomas

18889908327trials@soterixmedical.com

More Information

Sponsor

Soterix Medical

Last update posted

Nov 10, 2025

Last verified

Oct, 2025

Keywords

  • tDCS
  • mindulness
  • tES
  • electrotherapy
  • depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Soterix Medical on 2025-11-10.