Status:
COMPLETED
Cranial Electrotherapy Stimulation for the Treatment of Major Depressive Disorder in Adults
Lead Sponsor:
Fisher Wallace Laboratories
Collaborating Sponsors:
NAMSA
Climb Technologies, Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief 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 Dep...
Detailed Description
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 Stim...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2022
Estimated Enrollment :
255 Patients enrolled
Trial Details
Trial ID
NCT05384041
Start Date
April 28 2022
End Date
October 24 2022
Last Update
March 12 2024
Active Locations (1)
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1
New York Neuromodulation Medical, PLLC
New York, New York, United States, 10023