pilot study using transcranial electrostimulation (tesa-hb) therapy for the treatment of depressive symptoms

Conditions: Mild to Moderate Depression

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.

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 \ 29 * high variability in baseline mdi scores (changes more than 30%) * ham-d21 rating scale of \ 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

Keywords: depression, transcranial electronic stimulation, pilot, open label, safety, efficacy