Fisher Wallace Neurostimulation & Depression Study

Not Applicable

Active, not recruiting

• Conditions: Major Depressive Disorder
• Interventions: Device: Fisher Wallace Cranial Electrotherapy Stimulator Device

• Registration Number: NCT04541563
• Lead Sponsor: ProofPilot

Brief Summary

Examine the safety and effectiveness of the Fisher Wallace Cranial Electrotherapy Stimulator Device on Major Depressive Disorder using two 20-minute per day treatment sessions over eight weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-14
• Study Start: 2020-08-24
• Study First Submitted QC: 2020-09-01
• Study First Posted: 2020-09-09
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-11
• Primary Completion: 2021-03-30
• Study Completion: 2021-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immediate Treatment Arm	Fisher Wallace Cranial Electrotherapy Stimulator Device	The immediate treatment arm participants will be shipped an active Fisher Wallace device limited to Level 2 output even if a participant raises the dial beyond that. The participant will remain with the active device for the full 8 weeks.
Delayed Treatment Arm	Fisher Wallace Cranial Electrotherapy Stimulator Device	In the delayed treatment arm, the participants will receive a sham device that looks exactly the same, but only provides treatment for 2 seconds. At week 4, sham arm participants will be unblinded and shipped an active device (limited to Level 2 output even if a participant raises the dial beyond that). The delayed arm participants will continue with active devices for the remaining 4 weeks of the trial.

Primary Outcome Measures

Name	Time	Method
Change in Beck Depression Inventory Score Baseline vs week 4	Week 4	Change in depression symptoms from baseline to treatment week 4 in immediate versus delayed arm. Lower scores show improvement in depression symptoms.

Secondary Outcome Measures

Name	Time	Method
Systematic Assessment for Treatment Emergent Events (SAFTEE) at week 8	Week 8	assessment at week tolerability, safety and adherence at week 8
Change in Beck Depression Inventory Score Delay Arm Week 4 to Week 8	Week 8	Participants will self assess at point of receiving active device at crossover for the remaining 4 weeks of the trial. Lower scores show improvement in depression symptoms.
Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 4	Week 4	Change in self reported depression self assessed at baseline and week 4. Lower scores in the PHQ-8 show improvement in depression symptoms
Change in Hamilton Depression Score Baseline vs week 4	Week 4	Participants will be assessed by a tele-psychiatrist at baseline and week 4. Lower scores show improvement in depression symptoms.
Change in Hamilton Depression Score Baseline vs week 2	Week 2	Participants will be assessed by a tele-psychiatrist at baseline and week 2. Lower scores show improvement in depression symptoms.
Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs week 2	Week 2	Change in self reported depression self assessed at baseline and week 2. Lower scores in the PHQ-8 show improvement in depression symptoms.

Trial Locations

Locations (1)

ProofPilot (Remote Virtual Trial); 🇺🇸 New York, New York, United States