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

Mild to Moderate Depression Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Depression
• Mild to Moderate Depression

• NCT number: NCT03471754
• Study type: Interventional
• Source: Annecto LLC
• Status: Terminated
• Phase: N/A
• Start date: September 26, 2017
• Completion date: January 31, 2019