Transcranial direct current stimulation plus mindfulness for unipolar depression

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

This project will test whether adding transcranial direct current stimulation (tDCS) to remotely delivered mindfulness helps adults with unipolar depression feel less depressed.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Soterix Medical (industry)
• Locations: 1 site (Woodbridge, New Jersey)
• Trial ID: NCT07042217 on ClinicalTrials.gov

What this trial studies

This is a randomized, sham-controlled intervention in 25 adults with unipolar major depressive disorder that combines transcranial direct current stimulation (tDCS) with mindfulness instruction delivered via a telemedicine protocol. Participants receive either active tDCS plus mindfulness or sham tDCS plus mindfulness. Key entry requirements include a current major depressive episode of at least 4 weeks, clinician-confirmed diagnosis, elevated symptom scores on QIDS-SR and HDRS-17, and a stable antidepressant regimen for at least 30 days. Exclusions include recent substance abuse, concurrent benzodiazepine use, failure to respond to multiple prior antidepressant treatments or brain-stimulation therapies, and high suicide risk.

Who should consider this trial

Good fit: Adults with DSM-confirmed unipolar major depressive disorder currently in an episode of at least 4 weeks, with QIDS-SR and HDRS-17 scores in the study's entry range and on stable antidepressant medication for ≥30 days are ideal candidates.

Not a fit: People who have not responded to at least two antidepressants or to ECT/rTMS, who have recent substance or alcohol dependence, use benzodiazepines, or are judged at high suicide risk are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If effective, this combined, remotely delivered approach could reduce depressive symptoms and offer an accessible nonpharmacologic option.

How similar studies have performed: Previous tDCS trials for depression have shown mixed but sometimes modest benefits, and combining tDCS with mindfulness and fully remote delivery is a relatively novel approach with limited prior data.

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

Where this trial is running

Woodbridge, New Jersey

• Soterix Medical, Inc. — Woodbridge, New Jersey, United States (RECRUITING)

Study contacts

• Study coordinator: Paul Thomas Researcher

Conditions: Unipolar Depression, tDCS, mindulness, tES, electrotherapy, depression