Safety And Efficacy of Remotely Supervised Home-Based tDCS Treatment Of Major Depressive Disorder
The REACH-tDCS study will evaluate the safety and efficacy of a noninvasive, at-home self-administered Sooma tDCS brain stimulation treatment for Major Depressive Disorder. The study uses randomized, blinded, placebo controlled design. The participants are assessed with video interviews and self-reports during the study, which lasts for 10 weeks followed by an optional continuation period.
• 22 - 70 years of age
• Diagnosis of Unipolar MDD (DSM-V)
• PHQ-9 score of ≥13 AND MADRS score of ≥ 20 at baseline
• Antidepressant medication ongoing
• If in psychotherapy, have maintained stable psychotherapy
• Have access to a smartphone or other device running Android 7.0+ or iPhone Operating System (iOS) 13+
• Be under the care of a psychiatrist or a primary care physician
• Allow communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years
• Provide the name and contact of at least two adult persons who reside within a 60-minute drive of the patient's residence.
• Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
• Be willing and able to comply with all study procedures
• Agree to meet all of the inclusion criteria throughout their participation in the study. Otherwise, the subject will be discontinued from the study
• Be able to understand, speak, and read English sufficient for the completion of trial assessments