Cranial Electrotherapy Stimulation for the Treatment of Major Depressive Disorder in Adults

This prospective, fully remote, randomized, controlled, triple-blind (subject, Principal Investigator, Sponsor) pivotal 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.

Inclusion criteria

• Age 21-65 years and a resident of the United States of America
• Meets DSM-5 diagnostic criteria for moderate to severe Major Depressive Disorder
• Baseline BDI-II score between 20 and 63, inclusive (in moderate to severe range)
• Able to receive packages to their home via United Parcel Service/Fedex/United States Postal Service or other delivery service
• Willing and able to send and receive study related text messages on an internet capable mobile device throughout the duration of the study
• Owns and uses a personal, verifiable email address
• Able to commit to two (2) 20-minute treatment sessions per day for 4 weeks, one treatment upon waking for the day and one treatment before going to bed
• Willing to abstain from use of recreational drugs, hypnotics, steroids, and/or marijuana products through study completion
• Willingness to not initiate treatment for a mental health issue during the course of the study
• Fluent in English
• Sexually active females of childbearing potential willing to commit to practicing at least one or more of the following methods of contraception during the study: intrauterine device (IUD), barrier method in combination with a spermicide, oral/hormonal contraception, or abstinence
• In the opinion of the investigator, able to comply with study requirements and complete the study

Exclusion criteria

• History of suicide attempt or active suicidal ideation with plan or intent in the past 30 days.
• In the opinion of the investigator, considered high risk of suicide
• Previous hospitalization or institutionalization for mental health condition within one year of study entry
• Underwent electronic brain stimulation or neuromodulation within the past one year, including CES, transcranial magnetic stimulation, electroconvulsive therapy, and deep brain stimulation
• Modification of prescription medications that affect the nervous system (e.g., psychotropic medications) within 30 days of study entry
• Use of recreational drugs, hypnotics, steroids, and/or marijuana products in the past 30 days
• History of alcohol use disorder or other substance use disorder in the past 12 months
• Females currently pregnant or planning to conceive during study participation, or unwilling to comply with birth control requirements
• Known history of heart disease
• Known history of trigeminal neuralgia
• Implanted with an electronic device such as a defibrillator, deep brain stimulator, or pacemaker
• Unstable medical condition including any condition requiring hospitalization or change in treatment in the prior 30 days
• Legally blind and/or deaf and without in-home care service to assist with study participation
• Meets M.I.N.I. assessment criteria for, or has been diagnosed with, any of the following: Bipolar I disorder, bipolar II disorder, other specified bipolar and related disorder, panic disorder, agoraphobia, social anxiety disorder (social phobia), obsessive-compulsive disorder, posttraumatic stress disorder, alcohol use disorder in the past 12 months, substance use disorder (non-alcohol) in the past 12 months, any psychotic disorder (e.g., schizophrenia, schizoaffective disorder), major depressive disorder with psychotic features, anorexia nervosa, bulimia nervosa, binge-eating disorder, generalized anxiety disorder, any cognitive or developmental disorder (e.g., autism, Down's Syndrome), any personality disorder or psychiatric disorder that may interfere with study participation
• Current participation in another investigational study or participated in an investigational study within the past 30 days
• In the opinion of the investigator, may not be able to comply with study requirements
• Any employee, family member, or personal associate of the Sponsor or their designees conducting the study