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

NCT05384041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2024-03-12

Study results available
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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.

Conditions

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Climb Technologies, Inc.

    collaborator INDUSTRY

  • Fisher Wallace Laboratories

    lead INDUSTRY

Principal Investigators

  • Kyle Lapidus, MD, PhD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-28
Primary Completion
2022-09-30
Completion
2022-10-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05384041 on ClinicalTrials.gov