Transcranial Direct Current Stimulation for Depression
Soterix Medical · NCT07042217
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 22+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 25
- US sites recruiting
- 1
- Study start
- July 1, 2025
- Record last updated
- October 19, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: transcranial direct current stimulation (tDCS) and mindfulness instruction; Sham tDCS and Mindfulness
Conditions: Unipolar Depression
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Soterix Medical, Inc.
Woodbridge, NJ 07095
Site contact: Paul Thomas · 18889908327 · trials@soterixmedical.com
Study contacts (from the official record)
- Paul Thomas Researcher · 18889908327 · trials@soterixmedical.com
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