Transcranial direct current stimulation plus mindfulness for unipolar depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Soterix Medical, Inc.
  Woodbridge, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Paul Thomas Researcher
• Email: trials@soterixmedical.com
• Phone: 18889908327

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.