NCT03471754

Pilot Study Using Transcranial Electrostimulation (TESA-HB) Therapy for the Treatment of Depressive Symptoms

Pilot Study Using Transcranial Electrostimulation (TESA-HB) Therapy for the Treatment of Depressive Symptoms Associated With Mild to Moderate Depressive Episodes

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Annecto LLC · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This pilot study uses TESA-HB therapy for treatment of depressive symptoms associated with mild and moderate depression episodes. Primary objectives of this pilot study are to demonstrate the safety of TESA-HB Therapy, and to investigate the efficacy of TESA-HB Therapy for depressive symptoms.

Detailed description

The primary indicator variable in this study is the Hamilton Depression Rating Scale (HAM-D21), and secondary efficacy outcomes will be measured using: * Major Depression Inventory * Montgomery - Asberg Depression Rating Scale (MADRS) * Beck's Depression Inventory * Beck's Anxiety Inventory * Hamilton Anxiety Rating Scale (HAM-A) * The Psychological General Well-Being Index (PGWB-S) The safety endpoints include: * Medication Usage Log * Adverse Event Log Study Population includes men and women who are: * Diagnosed with a mild to moderate depressive episode * Have no recent history of taking antidepressant or anti-anxiety medication within 3 months prior to baseline

Conditions

• Mild to Moderate Depression

Interventions

Type	Name	Description
DEVICE	TESA-HB Transcranial Electronic Stimulation Device	Duration of treatment: 50 Minute Therapy sessions administered one time each day, for two 5-day cycles

Timeline

• Start date: 2017-09-26
• Primary completion: 2019-01-31
• Completion: 2019-01-31
• First posted: 2018-03-21
• Last updated: 2019-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study