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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 ;


Study Design


Related Conditions & MeSH terms


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

See also
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