Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
175 participants
INTERVENTIONAL
2020-08-24
2021-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
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.
TREATMENT
QUADRUPLE
Participants will be unblinded at week 4 at the crossover.
Study Groups
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Immediate 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.
Fisher 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.
Delayed Treatment Arm
In the delayed treatment arm, the participants will receive a sham device that looks exactly the same, but only provides treatment for 2 seconds. At week 4, sham arm participants will be unblinded and shipped an active device (limited to Level 2 output even if a participant raises the dial beyond that). The delayed arm participants will continue with active devices for the remaining 4 weeks of the trial.
Fisher 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.
Interventions
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Fisher 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.
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
ALL
Yes
Sponsors
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Fisher Wallace
UNKNOWN
ProofPilot
INDUSTRY
Responsible Party
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Locations
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ProofPilot (Remote Virtual Trial)
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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2518
Identifier Type: -
Identifier Source: org_study_id
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