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NCT Number: NCT07042217

Transcranial Direct Current Stimulation for Depression

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.

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Key information

Conditions

Unipolar Depression Behavior Behavioral Symptoms Depression Depressive Disorder Mental Disorders Mood Disorders

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Soterix Medical, Inc.

Woodbridge, New Jersey, 07095, United States

Location status: Recruiting

Location contact

Paul Thomas

CONTACT

[email protected]

18889908327

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcranial direct current stimulation (tDCS) and mindfulness instruction

Device

tDCS together with audio providing mindfulness instruction and music

Sham tDCS and Mindfulness

Device

Placebo electrical sitmulation and audio-guided mindfulness instruction

Primary outcomes

  1. Hamilton Depression Rating Scale (HDRS)

    Time frame: Week 4 and Week 7

    Change in HDRS score from Baseline

  2. Blinding Integrity

    Time frame: Week 7

    Participants will be asked to guess whether they received active or sham treatment, providing a third option of "don't know"

Secondary outcomes

  1. Response and Remission rates defined by HDRS

    Time frame: Week4, Week 7, Week 10, and Week 13

    Response rate, defined as a reduction in the HDRS score by 50% or more, and the remission rate, defined as an HDRS score ≤7.

  2. Quick Inventory of Depressive Symptomatology- Self Report (QIDS-SR)

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13

    Safety outcome will be tested using the QIDS-SR through a web portal

  3. Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13

    Participants will enter responses to the Q-LES-Q-SF questionnaire through the web interface

  4. Clinical Global Impression severity (CGI-S) and improvement (CGI-I) subscales

    Time frame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, and Week 13

    Participants will enter responses to the CGI-S and CGI-I questionnaires through the web interface

  5. Sheehan Disability Scale (SDS)

    Time frame: Baseline, Week 7, and Week 13

    Participants will be scored on the SDS at Baseline and at the end of the acute and maintenance phases.

  6. Montgomery-Asburg Depression Rating Scale (MADRS)

    Time frame: Baseline, Week 7 and Week 13

    Trained clinical MADRS scores will be obtained at the end of the Acute phase and Maintenance phase.

Other outcomes

  1. Adverse Event Questionnaire

    Time frame: 5 times per week for 7 weeks

    Participants will report any side effects experienced, their severity (mild, moderate, severe), pain scores based on the Wong-Baker pain scale, and temporal relationship with the tDCS session (before, during, after)

  2. Current Mood Score

    Time frame: 5 times per week for 7 weeks

    Participants will enter a daily mood score on a scale of 0-10 (0= feeling normal and not depressed at all and 10= feeling as depressed as they possibly could be) on the web interface

Study contacts

Contact information is provided by the study sponsor or research team.

Paul Thomas Researcher

CONTACT

[email protected]

18889908327 ext. 104

Sponsors and collaborators

Lead sponsor

Soterix Medical

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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