Potential Use Of Brain Network Activation Analysis Using Evoked Response Potentials to Diagnose Major Depression and Assess Response to Antidepressant Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Brain Network Analysis group patterns
研究概览
简要总结
The investigators are doing this study to find out if they can use electroencephalographic (EEG) recordings, which measure brain waves, to predict response to antidepressant treatments, as well as to distinguish patients who have depression from those who do not. In particular the investigators want to test the usefulness of a new type of analysis of EEG recordings called brain network activation or BNA. BNA allows to identify patterns of activation in brain networks and to track their changes over time.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Male and female outpatients, aged 18-55 years
- •Subjects meeting full criteria for the diagnosis of current Major Depressive Disorder (MDD) without psychotic features, as determined by clinical evaluation and Mood Module of structured diagnostic interview (SCID), completed by the study clinician.
- •HAM-D17 score of 14 or higher
- •Able to provide informed consent
- •Right handed, normal (corrected) vision and normal hearing
排除标准
- •• Other primary diagnoses including major depressive disorder with psychotic features, bipolar disorder, schizoaffective disorder, schizophrenia, dementia, attention deficit hyperactivity disorder (ADHD).
- •Substance use disorder (abuse or dependence with active use within the last 6 months).
- •Significant sensory deficits such as deafness or blindness.
- •Severe or unstable medical illness, including history of closed head injury resulting in loss of consciousness, seizure disorder; history of neurological disorders.
- •Pregnant or nursing females who are not using an accepted method of contraception (birth control pill, IUD, combination of barrier methods)
- •Clinically significant abnormal laboratory values or electrocardiogram For Healthy Controls
- •Inclusion Criteria:
- •Males and females, aged 18-55 years
- •Subjects who do not meet full criteria for any of the major psychiatric diagnosis including MDD, bipolar disorder, schizophrenia, substance abuse/dependence, attention deficit hyperactivity disorder (ADHD), as determined by clinical evaluation and structured diagnostic interview, completed by the study clinician.
- •Right handed, normal (corrected) vision and normal hearing
- •Exclusion Criteria:
- •Any current primary psychiatric, or medical condition determined to be clinically significant.
- •Current use of psychotropics or any medication with clinically significant central nervous system effects.
结局指标
主要结局
Brain Network Analysis group patterns
时间窗: 8 weeks
The investogators will make a comparison of Functional networks of brain activity (BNA™) in subjects with MDD and healthy individuals measured using analysis of EEG Event Related Potential (ERP) data \[ Time Frame: Baseline, 1 week after the first dose of antidepressant treatment, end of the treatment phase\].
次要结局
- Identify possible predictors of treatment response(8 weeks)
研究者
Cristina Cusin, MD
Principal Investigator
Massachusetts General Hospital