NCT07042217 Transcranial Direct Current Stimulation for Depression
| NCT ID | NCT07042217 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Soterix Medical |
| Condition | Unipolar Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 25 participants in total. It began in 2025-07-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07042217 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Unipolar Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07042217 currently recruiting?
Yes, NCT07042217 is actively recruiting participants. Contact the research team at trials@soterixmedical.com for enrollment information.
Where is the NCT07042217 trial being conducted?
This trial is being conducted at Woodbridge, United States.
Who is sponsoring the NCT07042217 clinical trial?
NCT07042217 is sponsored by Soterix Medical. The trial plans to enroll 25 participants.
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