Clinical trial NCT04703972: Identification of Predictive Biomarkers of Mood Relapses in Patients With Bipolar Disorder
Official title: Identification of Predictive Biomarkers of Mood Relapses in Patients With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bipolar Disorder
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Commissariat A L'energie Atomique
First posted: 2021-01-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Prediction of mood relapses
timeFrame: at Month 6 of the follow-up
Secondary outcomes:
measure: Correlation between values of Heart rate variability and the occurrence of a thymic relapse (number of relapses during the follow-up period).
timeFrame: at Month 6 of the follow-up
measure: Correlation between values of skin surface temperature and the occurrence of a thymic relapse (number of relapses during the follow-up period).
timeFrame: at Month 6 of the follow-up
measure: Correlation between values of actimetry and the occurrence of a thymic relapse (number of relapses during the follow-up period).
timeFrame: at Month 6 of the follow-up
measure: Correlation between ElectroDermal activity and the occurrence of a thymic relapse (number of relapses during the follow-up period).
timeFrame: at Month 6 of the follow-up
measure: Correlation between sleep periods and the occurrence of a thymic relapse (number of relapses during the follow-up period).
timeFrame: at Month 6 of the follow-up
measure: Correlation between social measures and the occurrence of a thymic relapse (number of relapses during the follow-up period).
timeFrame: at Month 6 of the follow-up
measure: Correlation between values of clinical characteristics (age of onset) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
timeFrame: at Month 6 of the follow-up
measure: Correlation between values of clinical characteristics about thyme episode and the occurrence of a thymic relapse (number of relapses during the follow-up period).
timeFrame: at Month 6 of the follow-up
measure: Correlation between values of clinical characteristics (suicide attempts) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
timeFrame: at Month 6 of the follow-up
measure: Correlation between values of clinical characteristics (hospitalizations) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
timeFrame: at Month 6 of the follow-up
measure: Correlation between values of clinical characteristics (comorbid disorders) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
timeFrame: at Month 6 of the follow-up
measure: Correlation between values of clinical characteristics (medication) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
timeFrame: at Month 6 of the follow-up
Other outcomes:
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