Identification of Predictive Biomarkers of Mood Relapses in Patients With Bipolar Disorder

NCT ID: NCT04703972

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2022-06-30

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Bipolar Patients with connected devices

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

Group Type: EXPERIMENTAL

clinical assessment (mood relapses identification)

Intervention Type: BEHAVIORAL

clinical assessment via psychometric scales physiological data acquired automatically via the connected device (wristwatch, wristband)

Interventions

clinical assessment (mood relapses identification)

clinical assessment via psychometric scales physiological data acquired automatically via the connected device (wristwatch, wristband)

Intervention Type: BEHAVIORAL

Other Intervention Names

physiological data monitoring

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Commissariat A L'energie Atomique

OTHER_GOV

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Mircea POLOSAN, MD-PhD

Role: CONTACT

MPolosan@chu-grenoble.fr

04 76 76 54 11

Arnaud Pouchon, MD

Role: CONTACT

APouchon@chu-grenoble.fr

04 76 76 54 11

Other Identifiers

38RC20.087

Identifier Type: -

Identifier Source: org_study_id