Transcranial Direct Current Stimulation for Depression

Launched by SOTERIX MEDICAL · Jun 26, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help adults with unipolar depression, a common type of depression where people experience ongoing low mood. The study will test a treatment called transcranial direct current stimulation (tDCS), which uses a small, gentle electrical current applied to the head to help improve brain activity. This will be combined with mindfulness practices, like guided meditation, and both parts of the treatment will be delivered remotely through telemedicine, meaning participants can take part from home.

To join the study, adults need to have a confirmed diagnosis of major depressive disorder and be currently experiencing a depressive episode lasting at least four weeks. They must have stable symptoms and be on steady antidepressant medication if they are taking any. Women who could become pregnant need to use birth control. People with certain conditions, such as other serious mental illnesses, recent substance abuse, or implanted medical devices like pacemakers, will not be eligible. If you participate, you can expect to receive the tDCS treatment and mindfulness sessions remotely, with close monitoring by the study team to see if this combined approach helps reduce depressive symptoms. This trial is not yet recruiting participants but aims to find new, accessible ways to support people living with depression.

Gender

ALL

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:
• • Current DSM-V-TR psychotic disorder
• • 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 in this or any previous episode.
• • Failure to respond to rTMS therapy in this or any previous episode.
• • 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