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Recruiting
NCT07042217
Transcranial Direct Current Stimulation for Depression
Conditions: Unipolar Depression
Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 25
Sponsor: Soterix Medical
Location: Soterix Medical, Inc. Woodbridge New Jersey
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
Source: ClinicalTrials.gov (NCT07042217). StuddyBuddy aggregates publicly available trial information.