Identification of Predictive Biomarkers of Mood Relapses in Patients With Bipolar Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- Prediction of mood relapses
研究概览
简要总结
Relapses in bipolar disorders are associated with a significant proportional functional impact, as well as worsening of the course of bipolar disorder, with impairment of the quality of functional remission, as well as the development of addictive, anxiety and suicidal comorbidities.The functional deficit and the instability of the mood disorder increase with thymic relapses. Currently, these relapses (transition from the state of remission, to a depressive or hyperthymic state) are difficult to predict and to treat because of the absence of correlation between the degree of severity of the stressful event (intensity associated stress) and the occurrence of relapse, taking into account the mediation of this relationship by the stress compensation / adaptation capacities, which are very individual.
This project proposes to develop tools based on artificial intelligence technologies to monitor the level of stress and adaptation to life events as well as identifying relapse predictive factors of a patient by using portable and connected devices recording different physiological signals in order to alert him/her when there is a risk of relapse, thus anticipating therapeutic strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Voluntary subjects responding to the diagnosis of bipolar I or II disorder according to the criteria of the DSM-5
- •Agreement to benefit from connected objects required for study and able to understand their use
- •Age between 18 and75 years old
- •Affiliated to the Social Security system (beneficiary or entitled)
- •No opposition signed
排除标准
- •Subject included in clinical and/or therapeutic experimentation with exclusion period
- •Primary psychiatric pathology other than bipolar type I or II disorder
- •Patient hospitalized without consent
- •Subject deprived of liberty by judicial or administrative decision
- •Pregnant, parturient, breastfeeding woman
- •Known allergy to one of the materials of the bracelets
结局指标
主要结局
Prediction of mood relapses
时间窗: at Month 6 of the follow-up
number of relapses predicted by machine learning algorithms versus number of relapses highlighted by clinical assessment
次要结局
- Correlation between values of skin surface temperature and the occurrence of a thymic relapse (number of relapses during the follow-up period).(at Month 6 of the follow-up)
- Correlation between ElectroDermal activity and the occurrence of a thymic relapse (number of relapses during the follow-up period).(at Month 6 of the follow-up)
- Correlation between sleep periods and the occurrence of a thymic relapse (number of relapses during the follow-up period).(at Month 6 of the follow-up)
- Correlation between values of Heart rate variability and the occurrence of a thymic relapse (number of relapses during the follow-up period).(at Month 6 of the follow-up)
- Correlation between values of actimetry and the occurrence of a thymic relapse (number of relapses during the follow-up period).(at Month 6 of the follow-up)
- Correlation between values of clinical characteristics (suicide attempts) and the occurrence of a thymic relapse (number of relapses during the follow-up period).(at Month 6 of the follow-up)
- Correlation between values of clinical characteristics (medication) and the occurrence of a thymic relapse (number of relapses during the follow-up period).(at Month 6 of the follow-up)
- Correlation between social measures and the occurrence of a thymic relapse (number of relapses during the follow-up period).(at Month 6 of the follow-up)
- Correlation between values of clinical characteristics about thyme episode and the occurrence of a thymic relapse (number of relapses during the follow-up period).(at Month 6 of the follow-up)
- Correlation between values of clinical characteristics (comorbid disorders) and the occurrence of a thymic relapse (number of relapses during the follow-up period).(at Month 6 of the follow-up)
- Correlation between values of clinical characteristics (age of onset) and the occurrence of a thymic relapse (number of relapses during the follow-up period).(at Month 6 of the follow-up)
- Correlation between values of clinical characteristics (hospitalizations) and the occurrence of a thymic relapse (number of relapses during the follow-up period).(at Month 6 of the follow-up)