Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in the USA / NCT04541563
Active, not recruiting Not applicable

Fisher Wallace Neurostimulation & Depression Study

NCT04541563 · tracked via the Priya Life Science USA tracker
Sponsor
ProofPilot
Phase
Not applicable
Started
2020-08-24
Last updated
2021-02-11

Condition(s) studied

Major Depressive Disorder

Investigational drug(s) / intervention(s)

Fisher Wallace Cranial Electrotherapy Stimulator 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.

Study 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.

Eligibility

Sex
ALL
Min age
21 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
ProofPilot (Remote Virtual Trial) New York New York

More ProofPilot trials in the USA

Brain Stimulation & Generalized Anxiety Study Active, not recruiting
Evaluation of a Neurostimulation Device for Insomnia: A Randomized Trial Active, not recruiting

Other trials for the same condition

Study of ABX-002 for the Adjunctive Treatment of Major Depressive Disorder (AMPLIFY) Recruiting
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium Recruiting
Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder Recruiting
A Study to Evaluate BMS-986511 in Adults With Major Depressive Disorder Starting soon
Assess the Utility of a Speech-based Machine Learning Algorithm to Predict Treatment Response to Psychiatric Interventions Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04541563 on ClinicalTrials.gov ↗ ← All trials in the USA