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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:

• 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.

Locations
United States
New Jersey
Soterix Medical, Inc.
RECRUITING
Woodbridge
Contact Information
Primary
Yishai Valter Researcher
trials@soterixmedical.com
18889908327
Time Frame
Start Date: 2025-07-01
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 25
Treatments
Experimental: Active tDCS and Mindfulness
Application of electrical stimulation to the brain non-invasively combined with mindfulness
Sham_comparator: Sham tDCS and Mindfulness
Sham electrical stimulation and mindfulness
Related Therapeutic Areas
Major Depression
Sponsors
Leads: Soterix Medical

This content was sourced from clinicaltrials.gov

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