Transcranial Direct Current Stimulation for Depression
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Unipolar Depression
In brief
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.
Key facts
- Study ID
- NCT07042217
- Run by
- Soterix Medical
- People needed
- 25
- Starts
- 2025-07-01
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2025-11-10
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- Soterix Medical, Inc. — Woodbridge, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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