Major Depressive Disorder
Conditions
Brief summary
Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device on Major Depressive Disorder using two 20-minute per day treatment sessions over eight weeks.
Interventions
DEVICEFisher Wallace Cranial Electrotherapy Stimulator Device
Fisher Wallace Stimulator®, a patented cranial electrotherapy stimulation device that was cleared by the FDA in 1991 for the treatment of depression, anxiety and insomnia.
Sponsors
Fisher Wallace
ProofPilot
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a fully remote trial. Participants will be randomized in ProofPilot, and only the fulfillment center will know whether the participant is in the placebo or control arm. Participants will be unblinded at week 4 at the crossover.
Intervention model description
This is a fully remote trial where participants engage at home in the study using the ProofPilot study platform. All potential participant enrollment data, including proof of identity via government ID will be reviewed by licensed medical professionals in the participant's state prior to their full enrollment. Participants will be randomized into an immediate or delayed treatment arm. The immediate treatment arm participants will be shipped an active Fisher Wallace device limited to Level 2 output even if a participant raises the dial beyond that. The participant will remain with the active device for the full 8 weeks.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age greater than or equal to 21 * US resident * Can receive packages to their home via UPS/Fedex/USPS * Major Depressive Disorder * PHQ-8 Score greater than 10 (show some signs of mild to moderate depression) * PHQ-8 Score less than 20 (given remote study serious depressed should be excluded) * Read/write English * have not contemplated suicide in the past year * not been institutionalized for mental health issues. * not currently experiencing problems with alcohol or drug abuse * can commit to not drinking alcohol 4 hours before bedtime for the duration of the study * can commit to two (2) 20 minute sessions per day for 8 weeks * has not used a brain stimulation treatment in one year * no suspected or known history of heart disease * no pacemaker * not under medical supervision for other serious medical condition * not taking opioids * is a resident of states in which we have licensed medical professionals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Beck Depression Inventory Score Baseline vs week 4 | Week 4 | Change in depression symptoms from baseline to treatment week 4 in immediate versus delayed arm. Lower scores show improvement in depression symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 4 | Week 4 | Change in self reported depression self assessed at baseline and week 4. Lower scores in the PHQ-8 show improvement in depression symptoms |
| Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 2 | Week 2 | Change in self reported depression self assessed at baseline and week 2. Lower scores in the PHQ-8 show improvement in depression symptoms. |
| Systematic Assessment for Treatment Emergent Events (SAFTEE) at week 8 | Week 8 | assessment at week tolerability, safety and adherence at week 8 |
| Change in Hamilton Depression Score Baseline vs week 4 | Week 4 | Participants will be assessed by a tele-psychiatrist at baseline and week 4. Lower scores show improvement in depression symptoms. |
| Change in Hamilton Depression Score Baseline vs week 2 | Week 2 | Participants will be assessed by a tele-psychiatrist at baseline and week 2. Lower scores show improvement in depression symptoms. |
| Change in Beck Depression Inventory Score Delay Arm Week 4 to Week 8 | Week 8 | Participants will self assess at point of receiving active device at crossover for the remaining 4 weeks of the trial. Lower scores show improvement in depression symptoms. |
Countries
United States
Outcome results
None listed