Clinical trial NCT04541563: Fisher Wallace Neurostimulation & Depression Study
Official title: Neurostimulation & Depression Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: ProofPilot
Sponsor class: INDUSTRY
Collaborators: name: Fisher Wallace
First posted: 2020-09-09
Enrollment: 175
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Beck Depression Inventory Score Baseline vs week 4
timeFrame: Week 4
Secondary outcomes:
measure: Systematic Assessment for Treatment Emergent Events (SAFTEE) at week 8
timeFrame: Week 8
measure: Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 4
timeFrame: Week 4
measure: Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 2
timeFrame: Week 2
measure: Change in Beck Depression Inventory Score Delay Arm Week 4 to Week 8
timeFrame: Week 8
measure: Change in Hamilton Depression Score Baseline vs week 4
timeFrame: Week 4
measure: Change in Hamilton Depression Score Baseline vs week 2
timeFrame: Week 2
Other outcomes:
Locations:
city: New York
country: United States
facility: ProofPilot (Remote Virtual Trial)
state: New York
Study officials:
References: