At a glance
ClinicalIndex Comparison Record- ✓Age 21-65 years and resident of the United States
- ✓Meets DSM-5 diagnostic criteria for moderate to severe Major Depressive Disorder
- ✓Baseline BDI-II score between 20 and 63 (moderate to severe range)
- ✓Able to commit to two 20-minute treatment sessions daily for 4 weeks, one upon waking and one before bed
- ✕History of suicide attempt or active suicidal ideation with plan or intent in the past 30 days
- ✕High risk of suicide per investigator assessment
- ✕Psychiatric hospitalization or institutionalization within 1 year of study entry
- ✕Prior electronic brain stimulation or neuromodulation within the past year (CES, TMS, ECT, DBS)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cranial Electrotherapy Stimulation for the Treatment of Major Depressive Disorder in Adults
In Brief
A clinical study evaluating Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) and Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) for Major Depressive Disorder. Completed, enrolled 255 participants across 1 site.
Detailed Summary
This study is designed to evaluate the safety and efficacy of the Fisher Wallace Stimulator FW-200 to deliver Cranial Electrotherapy Stimulation (CES) for the treatment of moderate to severe Major Depressive Disorder (MDD) in adults.
Study Details
Timeline
Interventions
The indicated use in adults (ages 21-65 years) is for 20 minutes twice daily, upon waking for the day and at bedtime. The treatment period of the intervention will have a duration of four weeks.
The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit.