Identification of Predictive Biomarkers of Mood Relapses in Patients With Bipolar Disorder (Predibip)

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Bipolar Disorder

Treatments: Behavioral: clinical assessment (mood relapses identification)

Study type: Interventional

Funder types: Other

Identifiers

NCT04703972

38RC20.087

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Bipolar Patients with connected devices

Experimental group

Description:

Patients with bipolar disorder provided with connected devices (wristwatch and wristband)

Treatment:

Behavioral: clinical assessment (mood relapses identification)