Transcranial Direct Current Stimulation for Depression

NCT07042217 | Recruiting FDA Device

• 1 other identifier: ELECTMDS
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

tDCS; mindulness; tES; electrotherapy; depression

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Rating Scale (HDRS)

  Change in HDRS score from Baseline

  Week 4 and Week 7

• Blinding Integrity

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

  Week 7

Secondary Outcomes (6)

• Response and Remission rates defined by HDRS

  Week4, Week 7, Week 10, and Week 13

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

  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

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

  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

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

  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

• Sheehan Disability Scale (SDS)

  Baseline, Week 7, and Week 13

Other Outcomes (2)

• Adverse Event Questionnaire

  5 times per week for 7 weeks

• Current Mood Score

  5 times per week for 7 weeks

Study Arms (2)

Active tDCS and Mindfulness

EXPERIMENTAL

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

Device: transcranial direct current stimulation (tDCS) and mindfulness instruction

Sham tDCS and Mindfulness

SHAM COMPARATOR

Sham electrical stimulation and mindfulness

Device: Sham tDCS and Mindfulness

Interventions

transcranial direct current stimulation (tDCS) and mindfulness instruction DEVICE

tDCS together with audio providing mindfulness instruction and music

Active tDCS and Mindfulness

Sham tDCS and Mindfulness DEVICE

Placebo electrical sitmulation and audio-guided mindfulness instruction

Sham tDCS and Mindfulness

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Soterix Medical: lead

Study Sites (1)

Soterix Medical, Inc.

Woodbridge, New Jersey, 07095, United States

RECRUITING

Related Links

• Sponsor's webpage with information about the study

MeSH Terms

Conditions

Depressive Disorder; Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Central Study Contacts

Paul Thomas Researcher

CONTACT

18889908327; trials@soterixmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 27, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)