Home-Based tDCS Treatment Of Major Depressive Disorder
ConditionMajor Depressive Disorder (MDD)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-70
SponsorSooma Medical Inc
About this trial
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.
Eligibility criteria
Qualifiers
22 - 70 years of age
Diagnosis of Unipolar MDD (DSM-V)
PHQ-9 score of ≥12 AND MADRS score of ≥ 20 at baseline
Antidepressant medication ongoing
Disqualifiers
Current state of mania or psychosis, or have a history of mania or psychosis.
Treatment resistant depression.
Are diagnosed with vitamin or hormonal deficiencies that may mimic mood disorders, as determined by the investigator.
Be currently receiving any other interventional therapy for MDD other than a stable regimen of antidepressants or psychotherapy as defined in the inclusion criteria or have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation.
Trial design
Treatments tested in this trial
- Transcranial direct current stimulation
- Sham transcranial direct current stimulation
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov