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

NCT04703972 | Unknown

• 1 other identifier: 38RC20.087
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Prediction of mood relapses

  number of relapses predicted by machine learning algorithms versus number of relapses highlighted by clinical assessment

  at Month 6 of the follow-up

Secondary Outcomes (12)

• 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 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 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 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

Study Arms (1)

Bipolar Patients with connected devices

EXPERIMENTAL

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

Behavioral: clinical assessment (mood relapses identification)

Interventions

clinical assessment (mood relapses identification) BEHAVIORAL

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

Also known as: physiological data monitoring

Bipolar Patients with connected devices

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Commissariat A L'energie Atomique: collaborator

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Central Study Contacts

Mircea POLOSAN, MD-PhD

CONTACT

04 76 76 54 11; MPolosan@chu-grenoble.fr

Arnaud Pouchon, MD

CONTACT

04 76 76 54 11; APouchon@chu-grenoble.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: January 11, 2021
• Study Start: January 13, 2021
• Primary Completion: January 31, 2022
• Study Completion: June 30, 2022
• Last Updated: January 14, 2021

Record last verified: 2020-05