Clinical trial NCT03471754: Pilot Study Using Transcranial Electrostimulation (TESA-HB) Therapy for the Treatment of Depressive Symptoms
Official title: Pilot Study Using Transcranial Electrostimulation (TESA-HB) Therapy for the Treatment of Depressive Symptoms Associated With Mild to Moderate Depressive Episodes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mild to Moderate Depression
Keywords: Depression, transcranial electronic stimulation, pilot, open label, safety, efficacy
Lead sponsor: Annecto LLC
Sponsor class: OTHER
Collaborators: name: Holy Redeemer Hospital
First posted: 2018-03-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot, Open Label, single center trial
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-65 years old on enrollment
* Assessed by Evaluator with mild to moderate depressive episode, based on the MDI Rating Scale (20-24 mild; 25-29 moderate).
* Have average MDI pain rating score of \> 20 or \<29 during baseline
* Assessed by Evaluator to have mild to moderate depressive episode, based on the HAM-D21 Rating Scale (8-13 = mild; 14-17 moderate).
* Assessed by Evaluator to have mild to moderate depressive episode based on ICD-10 Diagnostic Guidelines 1,2
* Willing and able to visit 2 weeks ( 5 times per week) as a clinic outpatient to participate in this clinical investigation
* Willing and able to return to the clinic for evaluation during the follow up period - 2 weeks, 1 month (4 wks), 2 months (8 wks), and 3 months (12wks) following the completion of TESA-HB Therapy
* Willing to be monitored, fill out daily medication logs, and appear for all physician visits for baseline, treatment and follow-up period
* English speaking and able to understand and approve the consent form, and understand and provide answers on the Depression and Anxiety assessment form and the Psychological General Well-Being Index (PGWB-S) questionnaires

Exclusion Criteria:• MDI Rating Scale of \< 20 or \> 29

* High variability in baseline MDI scores (changes more than 30%)
* HAM-D21 Rating Scale of \< 8 or \> 17
* Assessed outside of mild to moderate depression episode range based on the ICD-10 Diagnostic Guidelines 1,2
* Recent history of taking Antidepressant or Antianxiety medication within 3 months prior to baseline
* Is pregnant, or may be pregnant, or plans to become pregnant during the study period
* Sensitivity to electrodes and/or their conductive gels or adhesives
* Break in skin integrity at the areas of electrode placement
* Currently suspected use of narcotic
* Presence of any implanted electronic device, cardiac stimulator, or pacemaker
* History of brain injury, including seizures, epilepsy, stroke, tumor of central nervous system, or hydrocephalus
* Acute brain injuries, infections or tumor of central nervous system
* History of heart attacks within 1year congestive heart failure
* Blood pressure: \> 140 systolic and/or \> 90 diastolic
* History of schizophrenia
* Previous experience with Cranial Electrotherapy Stimulator (CES) devices
* Failure to complete 80% of daily medication logs or complete a questionnaire and two physician assessments during baseline period
* Failed to complete 75% of follow up visits or failed to complete more than 2 treatments will be excluded in the per-protocol (PP) analysis
* Acute psychiatric disorders (other than depression, insomnia and/or anxiety)
* Use of psychoactive drugs (other than antidepressants and/or anxiety)
* These subjects will continue to be followed in the study, but will be classified in the intent-to-treat (ITT) group
* HRHS employees, in an effort to protect their privacy, as the study will be conducted in a Holy Redeemer facility. Additionally, this exclusion was decided upon to minimize the possibility of coercion or undue influence in relationship with Holy Redeemer employees.
* Illiterate persons, as the study requires completion of assessments tools in the home setting where the subject may/may not have assistance with reading and understanding the tools, study documents and proceedures as required.
* Uninsured persons, to financially protect them in the rare instance that medical care would be required as a result of the study treatment

Primary outcomes:
measure: Hamilton Depression Rating Scale (HAM-D21)
timeFrame: Statistically significant improvement from baseline to end of study period (4 months)
measure: Medication Usage Log
timeFrame: Statistically significant improvement from baseline to end of study period (4 months)
Secondary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Statistically significant improvement from baseline to end of study period (4 months)
measure: Major Depression Inventory (MDI)
timeFrame: Statistically significant improvement from baseline to end of study period (4 months)
measure: The Psychological General Well-Being Index (PGWB-S)
timeFrame: Statistically significant improvement from baseline to end of study period (4 months)
measure: Beck's Depression Inventory (BDI)
timeFrame: Statistically significant improvement from baseline to end of study period (4 months)
measure: Beck's Anxiety Inventory (BAI)
timeFrame: Statistically significant improvement from baseline to end of study period (4 months)
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Statistically significant improvement from baseline to end of study period (4 months)
measure: Medication Usage Log (MUL)
timeFrame: Statistically significant improvement from baseline to end of study period (4 months)
Other outcomes:
Locations:
city: Bensalem
country: United States
facility: Holy Redeemer Health Care at Bensalem, 3300 Tillman Drive
state: Pennsylvania
Study officials:
affiliation: Holy Redeemer Hospital
name: Beth DuPree, MD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Annecto LLC
name: Yakov Katsnelson, MD
role: STUDY_DIRECTOR
References: