Actively Recruiting
Randomized Trial of ElectraRx Mindfulness Combined with Transcranial Direct Current Stimulation for Adults with Major Depressive Disorder
Led by Soterix Medical · Updated on 2025-11-10
25
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of transcranial direct current stimulation tDCS combined with mindfulness delivered remotely through telemedicine in adults with unipolar depression. This randomized, double-blind, sham-controlled trial involves 25 adults diagnosed with major depressive disorder who are currently experiencing a major depressive episode. The study aims to understand how this combined treatment affects depression symptoms using established rating scales. Participants will be randomly assigned to one of two groups one receiving active tDCS along with mindfulness audio instruction and music, and the other receiving sham placebo electrical stimulation combined with guided mindfulness audio. The treatment is non-invasive and delivered remotely. The study includes multiple assessments over several weeks to monitor changes and effects. During the study, participants will complete various depression rating scales such as the Hamilton Depression Rating Scale HDRS, Quick Inventory of Depressive Symptomatology, and Montgomery-Asburg Depression Rating Scale at scheduled intervals. Researchers will assess symptom severity, quality of life, global clinical impression, and disability. The trial includes blinding integrity checks and collects data up to 13 weeks to monitor response and remission rates. Participants will be monitored for safety throughout the study.
CONDITIONS
Brief Title
Transcranial Direct Current Stimulation for Depression
Research Team
P
Paul Thomas Researcher
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