Fisher Wallace Neurostimulation & Depression Study

Major Depressive Disorder Clinical Trial

Official title:

Neurostimulation & Depression Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04541563
• Other study ID #: 2518
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 24, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: February 2021
• Source: ProofPilot
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175
• Est. completion date: November 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion criteria:

• Age greater than or equal to 21

• US resident

• Can receive packages to their home via UPS/Fedex/USPS

• Major Depressive Disorder

• PHQ-8 Score greater than 10 (show some signs of mild to moderate depression)

• PHQ-8 Score less than 20 (given remote study serious depressed should be excluded)

• Read/write English

• have not contemplated suicide in the past year

• not been institutionalized for mental health issues.

• not currently experiencing problems with alcohol or drug abuse

• can commit to not drinking alcohol 4 hours before bedtime for the duration of the study

• can commit to two (2) 20 minute sessions per day for 8 weeks

• has not used a brain stimulation treatment in one year

• no suspected or known history of heart disease

• no pacemaker

• not under medical supervision for other serious medical condition

• not taking opioids

• is a resident of states in which we have licensed medical professionals

Related Conditions & MeSH terms

• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Fisher Wallace Cranial Electrotherapy Stimulator Device
Fisher Wallace Stimulator®, a patented cranial electrotherapy stimulation device that was cleared by the FDA in 1991 for the treatment of depression, anxiety and insomnia.

Locations

Country	Name	City	State
United States	ProofPilot (Remote Virtual Trial)	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
ProofPilot	Fisher Wallace

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Beck Depression Inventory Score Baseline vs week 4	Change in depression symptoms from baseline to treatment week 4 in immediate versus delayed arm. Lower scores show improvement in depression symptoms.	Week 4
Secondary	Systematic Assessment for Treatment Emergent Events (SAFTEE) at week 8	assessment at week tolerability, safety and adherence at week 8	Week 8
Secondary	Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs 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	Week 4
Secondary	Change in Patient Health Questionnaire - 8 (PHQ-8) Score Baseline vs 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.	Week 2
Secondary	Change in Beck Depression Inventory Score Delay Arm Week 4 to 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.	Week 8
Secondary	Change in Hamilton Depression Score Baseline vs week 4	Participants will be assessed by a tele-psychiatrist at baseline and week 4. Lower scores show improvement in depression symptoms.	Week 4
Secondary	Change in Hamilton Depression Score Baseline vs week 2	Participants will be assessed by a tele-psychiatrist at baseline and week 2. Lower scores show improvement in depression symptoms.	Week 2