Recruiting
Transcranial Direct Current Stimulation for Depression
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.
ClinicalTrials.gov IDNCT07042217
PhaseNA
Enrollment25
SponsorSoterix Medical
Age22 Years
SexALL
Conditions studied
Unipolar Depression
About this study
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.
Interventions
- Device: transcranial direct current stimulation (tDCS) and mindfulness instruction — tDCS together with audio providing mindfulness instruction and music
- Device: Sham tDCS and Mindfulness — Placebo electrical sitmulation and audio-guided mindfulness instruction
Primary outcomes
- Hamilton Depression Rating Scale (HDRS) (Week 4 and Week 7)
- Blinding Integrity (Week 7)
Eligibility information
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
Study locations
- Soterix Medical, Inc., Woodbridge, New Jersey 07095 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-28.