Mild to Moderate Depression
Conditions
Keywords
Depression, transcranial electronic stimulation, pilot, open label, safety, efficacy
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
Interventions
DEVICETESA-HB Transcranial Electronic Stimulation Device
Duration of treatment: 50 Minute Therapy sessions administered one time each day, for two 5-day cycles
Sponsors
Holy Redeemer Hospital
Annecto LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot, Open Label, single center trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale (HAM-D21) | Statistically significant improvement from baseline to end of study period (4 months) | The HAM-D21 will be analyzed as a single measure result |
| Medication Usage Log | Statistically significant improvement from baseline to end of study period (4 months) | Will be used in total, as a covariate in analysis of primary outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Psychological General Well-Being Index (PGWB-S) | Statistically significant improvement from baseline to end of study period (4 months) | Will be analyzed in total score |
| Beck's Depression Inventory (BDI) | Statistically significant improvement from baseline to end of study period (4 months) | Will be analyzed in total score |
| Montgomery-Asberg Depression Rating Scale (MADRS) | Statistically significant improvement from baseline to end of study period (4 months) | Will be analyzed in total score |
| Hamilton Anxiety Rating Scale (HAM-A) | Statistically significant improvement from baseline to end of study period (4 months) | Will be analyzed in total score |
| Medication Usage Log (MUL) | Statistically significant improvement from baseline to end of study period (4 months) | Will be analyzed in total score, with no covariate |
| Beck's Anxiety Inventory (BAI) | Statistically significant improvement from baseline to end of study period (4 months) | Will be analyzed in total score |
| Major Depression Inventory (MDI) | Statistically significant improvement from baseline to end of study period (4 months) | Will be analyzed in total score |
Countries
United States
Outcome results
None listed