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

NCT ID: NCT05384041

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 255 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-28
• Study Completion Date: 2022-10-24

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 Depressive Disorder (MDD) in adults.

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 Stimulator FW-200 to deliver Cranial Electrotherapy Stimulation (CES) for the treatment of moderate to severe Major Depressive Disorder (MDD) in adults.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)

The Fisher Wallace Stimulator provides cranial electrotherapy stimulation and is an active device.

Group Type: ACTIVE_COMPARATOR

Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)

Intervention Type: DEVICE

The indicated use in adults (ages 21-65 years) is for 20 minutes twice daily, upon waking for the day and at bedtime. The treatment period of the intervention will have a duration of four weeks.

Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)

The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit.

Group Type: PLACEBO_COMPARATOR

Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)

Intervention Type: DEVICE

The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit.

Interventions

Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)

The indicated use in adults (ages 21-65 years) is for 20 minutes twice daily, upon waking for the day and at bedtime. The treatment period of the intervention will have a duration of four weeks.

Intervention Type: DEVICE

Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)

The placebo device is designed to provide exactly the same patient experience as the active device; however, the placebo device will not deliver the same frequencies as the active device. The placebo device will provide no therapeutic benefit.

Intervention Type: DEVICE

Other Intervention Names

Fisher Wallace Stimulator FW-200; FW-200

Eligibility Criteria

Inclusion Criteria

1. Age 21-65 years and a resident of the United States of America

2. Meets DSM-5 diagnostic criteria for moderate to severe Major Depressive Disorder

3. Baseline BDI-II score between 20 and 63, inclusive (in moderate to severe range)

4. Able to receive packages to their home via United Parcel Service/Fedex/United States Postal Service or other delivery service

5. Willing and able to send and receive study related text messages on an internet capable mobile device throughout the duration of the study

6. Owns and uses a personal, verifiable email address

7. 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

8. Willing to abstain from use of recreational drugs, hypnotics, steroids, and/or marijuana products through study completion

9. Willingness to not initiate treatment for a mental health issue during the course of the study

10. Fluent in English

11. 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

12. In the opinion of the investigator, able to comply with study requirements and complete the study

Exclusion Criteria

1. History of suicide attempt or active suicidal ideation with plan or intent in the past 30 days.

2. In the opinion of the investigator, considered high risk of suicide

3. Previous hospitalization or institutionalization for mental health condition within one year of study entry

4. Underwent electronic brain stimulation or neuromodulation within the past one year, including CES, transcranial magnetic stimulation, electroconvulsive therapy, and deep brain stimulation

5. Modification of prescription medications that affect the nervous system (e.g., psychotropic medications) within 30 days of study entry

6. Use of recreational drugs, hypnotics, steroids, and/or marijuana products in the past 30 days

7. History of alcohol use disorder or other substance use disorder in the past 12 months

8. Females currently pregnant or planning to conceive during study participation, or unwilling to comply with birth control requirements

9. Known history of heart disease

10. Known history of trigeminal neuralgia

11. Implanted with an electronic device such as a defibrillator, deep brain stimulator, or pacemaker

12. Unstable medical condition including any condition requiring hospitalization or change in treatment in the prior 30 days

13. Legally blind and/or deaf and without in-home care service to assist with study participation

14. 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

15. Current participation in another investigational study or participated in an investigational study within the past 30 days

16. In the opinion of the investigator, may not be able to comply with study requirements

17. Any employee, family member, or personal associate of the Sponsor or their designees conducting the study

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NAMSA

OTHER

Sponsor Role: collaborator

Climb Technologies, Inc.

INDUSTRY

Sponsor Role: collaborator

Fisher Wallace Laboratories

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyle Lapidus, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

New York Neuromodulation Medical, PLLC

New York, New York, United States

Countries

United States

References

Gehrman PR, Bartky EJ, Travers C, Lapidus K. A Fully Remote Randomized Trial of Transcranial Alternating Current Stimulation for the Acute Treatment of Major Depressive Disorder. J Clin Psychiatry. 2024 Apr 22;85(2):23m15078. doi: 10.4088/JCP.23m15078.

Reference Type: DERIVED

PMID: 38696220 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FW-200-05

Identifier Type: -

Identifier Source: org_study_id