NCT03471754终止不适用
Pilot Study Using Transcranial Electrostimulation (TESA-HB) Therapy for the Treatment of Depressive Symptoms Associated With Mild to Moderate Depressive Episodes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Annecto LLC
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Medication Usage Log
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment Arm A
Experimental
TESA-HB Device, Mode 3 (15mA). Treatment arm involves two 5-day treatment cycles over a 2-week period, with 2 days off between each of the 5-day cycles. The treatment period will as for two full weeks.
干预措施: TESA-HB Transcranial Electronic Stimulation Device (Device)
结局指标
主要结局
Medication Usage Log
时间窗: 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
Hamilton Depression Rating Scale (HAM-D21)
时间窗: Statistically significant improvement from baseline to end of study period (4 months)
The HAM-D21 will be analyzed as a single measure result
次要结局
- The Psychological General Well-Being Index (PGWB-S)(Statistically significant improvement from baseline to end of study period (4 months))
- Montgomery-Asberg Depression Rating Scale (MADRS)(Statistically significant improvement from baseline to end of study period (4 months))
- Beck's Depression Inventory (BDI)(Statistically significant improvement from baseline to end of study period (4 months))
- Major Depression Inventory (MDI)(Statistically significant improvement from baseline to end of study period (4 months))
- Beck's Anxiety Inventory (BAI)(Statistically significant improvement from baseline to end of study period (4 months))
- Hamilton Anxiety Rating Scale (HAM-A)(Statistically significant improvement from baseline to end of study period (4 months))
- Medication Usage Log (MUL)(Statistically significant improvement from baseline to end of study period (4 months))
研究者
研究点 (2)
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