A Combination of Innovative Technologies: EEG, Eye Tracking Device and fMRI in Order to Predict the Success of SSRI Treatment in Patients With Major Depression.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- EEG responses to cognitive tasks in combination with the Eye-tracker Device.
研究概览
简要总结
This project will combine the data collected from EEG, Eye tracking, structural and functional MRI scans and neuropsychological performance from patients with major depression receiving SSRI treatment. The purpose of this research is to predict the success of the SSRI treatment and to categorize patients into sub-groups according to similar patterns of brain activation to personalize treatment.
详细描述
Major depression is a mood disorder affecting 350 million people worldwide. The disorder is characterized by depressed mood, anhedonia, decreased quality of life, deficits in cognitive functions and even suicide thoughts. Treatment of depression is often a long process and includes taking different types and quantities of medications. Therefore, there is a need to predict the success of the SSRI treatment. Our research will examine the outcomes of the combined technologies: BNA (EEG), Eye-tracker, structural and functional MRI scans and neuropsychology tasks in patients with depression while receiving SSRI treatment. The purpose of the research is to track biomarkers and other measures, which will allow predicting the SSRI treatment's success within 4 weeks instead of 8 weeks. In addition, the investigators will attempt to categorize patients into different subgroups according to their brain activation and eye movements. This division into subgroups may contribute to the understanding of the mechanisms that account for the responsiveness to SSRI treatment and to the possibility of targeting patients with depression towards a particular treatment. From this research, the investigators aim to personalize the treatment of depression, make it more efficient and reduce the amount of time for the patient to reach an optimal responsiveness.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients 18-65 years old
- •Male and female
- •Ability to comprehend and sign informed consent
- •DSM-5 diagnosis with MINI 7.0.2 (healthy subjects need to be ruled out)
- •Inclusion Criteria for patients with depression:
- •DSM-5 diagnosis
- •0-2 failed treatments
- •Patients which will start SSRI treatment
排除标准
- •unconsciousness
- •Pregnancy or nursing
- •Cardiovascular instability
- •Metabolic instability (water, electrolytes, sugar)
- •Fever or evidence of microbiological pollutant
- •Deafness or blindness
- •Schizophrenia
- •Addiction disorders
- •Eating disorders
- •Bi-polar disorder
- •Cognitive deficits
- •Start a new psychotherapy during the research
- •Unable to enter the MRI scanner
结局指标
主要结局
EEG responses to cognitive tasks in combination with the Eye-tracker Device.
时间窗: 2 years
Categorize patients into subgroups according to combined measures of EEG and Eye
次要结局
- Eye-tracking tasks(2 years)
- Examine MRI structural changes(2 years)
- Examine correlations between the different methods(2 years)
- EEG brain activation to cognitive tasks(2 years)
- Resting state connectivity analysis(2 years)
- Cognitive scores on CANTAB (computerized cognitive assessments)(2 years)