Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) for Melancholia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
New York Neuromodulation Medical, PLLC, New York, NY
Melancholia+4 More
Fisher Wallace Cranial Electrotherapy Stimulator - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Melancholia
  • Major Depressive Disorder (MDD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Change at weeks one and four compared to baseline.

Change at week two compared to baseline.
Change in the Beck Depression Inventory Second Edition (BDI-II) at week two compared to baseline.
Change at weeks one and four compared to baseline.
Change in the BDI-II at weeks one and four compared to baseline.
Change in the Beck Depression Inventory Second Edition (BDI-II) at weeks one and four compared to baseline.
Change at weeks one, two, and four compared to baseline.
Change in the Patient Health Questionnaire-9 (PHQ-9) at weeks one, two, and four compared to baseline.
Change in the Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR) at weeks one, two, and four compared to baseline.
Four weeks following baseline.
BDI-II responder rate at four weeks.
Beck Depression Inventory Second Edition (BDI-II) responder rate at four weeks.

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)
1 of 2
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)
1 of 2
Active Control
Non-Treatment Group

250 Total Participants · 2 Treatment Groups

Primary Treatment: Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) · Has Placebo Group · N/A

Fisher Wallace Cranial Electrotherapy Stimulator (Active Device)ActiveComparator Group · 2 Interventions: Fisher Wallace Cranial Electrotherapy Stimulator, Fisher Wallace Cranial Electrotherapy Stimulator (Active Device) · Intervention Types: Device, Device
Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device)PlaceboComparator Group · 2 Interventions: Fisher Wallace Cranial Electrotherapy Stimulator, Fisher Wallace Cranial Electrotherapy Stimulator (Placebo Device) · Intervention Types: Device, Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change at weeks one and four compared to baseline.
Closest Location: New York Neuromodulation Medical, PLLC · New York, NY
Photo of New York  1Photo of New York  2Photo of New York  3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Melancholia
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 21 years of age or older and a resident of the United States of America.
You have a moderate to severe Major Depressive Disorder.
You have a baseline BDI-II score between 20 and 63 inclusive (in moderate to severe range).
You are able to receive packages to your home.
You have a personal email address.
You are 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.
You are willing to not initiate treatment for a mental health issue during the course of the study.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.