Evaluation of Use of Brain Activity Monitoring for Early Identification of Pharmaceutical Treatment Efficacy and Development of Depression Deterioration Events.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 3
- 主要终点
- Tuning and evaluation of use of EEG analysis of brain prefrontal activity for mental status evaluation.
研究概览
简要总结
This study evaluates the use of brain activity monitoring for early identification of pharmaceutical treatment efficacy and development of depression deterioration events.
详细描述
The study will be conducted in two arms:
In arm I, participants diagnosed with depression. In arm II, healthy participants.
Arm I - Participants that need to start or switch their pharmacological antidepressant therapy will be recruited. Their clinical status will be evaluated and their EEG characteristics will be collected.
Arm II - Clinical and EEG characteristics of Healthy volunteers will collected on a similar timetable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the study.
- •Male or Female, aged 18 -70 years (Adult, Senior)
- •Able and willing to comply with all study requirements.
- •Additional Inclusion Criteria for Arm I
- •Diagnosed with depression
- •Being within 2 days of receiving pharmaceutical treatment for depression for the first
- •time or changing dose or changing type of current pharmaceutical treatment or addition to
- •drug of current pharmaceutical treatment.
- •Additional Inclusion Criteria for Arm II
- •Brief Symptom Inventory (BSI < 2.3).
排除标准
- •The participant may not enter the study if ANY of the following apply:
- •Diagnosed with Psychotic disorder.
- •Diagnosed with Central Neurological disorder.
- •A user of recreational or illicit drugs or has had a recent history of drug or alcohol abuse
- •or dependence.
- •Hearing disorder and/or known ear drum impairment.
- •High suicide risk as judged by the research team.
研究组 & 干预措施
Participants diagnosed with depression.
EEG monitoring and evaluation
干预措施: EEG monitoring (Device)
Healthy participants.
EEG monitoring and evaluation
干预措施: EEG monitoring (Device)
结局指标
主要结局
Tuning and evaluation of use of EEG analysis of brain prefrontal activity for mental status evaluation.
时间窗: 12 months
Outcome measures: optimal EEG device, sampling duration, frequency, and EEG measure dynamics correlation with depression clinical dynamics.
次要结局
未报告次要终点