Anxiety & Depression Association of America

Transcranial Direct Current Stimulation for Depression

Purpose

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.

Condition

Unipolar Depression

Eligibility

Eligible Ages: Over 22 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Active tDCS and Mindfulness	Application of electrical stimulation to the brain non-invasively combined with mindfulness	Device: transcranial direct current stimulation (tDCS) and mindfulness instruction tDCS together with audio providing mindfulness instruction and music
Sham Comparator Sham tDCS and Mindfulness	Sham electrical stimulation and mindfulness	Device: Sham tDCS and Mindfulness Placebo electrical sitmulation and audio-guided mindfulness instruction

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Soterix Medical

Study Contact

Paul Thomas R&D Engineer
18889908327
trials@soterixmedical.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.