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

Primary Purpose

Bipolar Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
clinical assessment (mood relapses identification)
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bipolar Disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Bipolar Patients with connected devices

    Arm Description

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Correlation between values of Heart rate variability and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Heart rate variability (HRV) (ms)
    Correlation between values of skin surface temperature and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Physical parameters measured: Skin surface temperature in °C
    Correlation between values of actimetry and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Physical parameters measured: Actimetry using accelerometer (movement per minute)
    Correlation between ElectroDermal activity and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    ElectroDermal activity (siemens)
    Correlation between sleep periods and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Sleep periods
    Correlation between social measures and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    The internet connection times (minute), including social networks, the number and duration (minute) of telephone calls and the number and length (number of characters) of text messages will be automatically recorded daily in order to provide parameters that help quantify the patient's social activity.
    Correlation between values of clinical characteristics (age of onset) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Age of onset (in years)
    Correlation between values of clinical characteristics about thyme episode and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Predominant polarity (hypo/manic or depressive or without), polarity of last episode (hypo/manic or depressive), number of previous thymic episodes, duration of remission (in month).
    Correlation between values of clinical characteristics (suicide attempts) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Number of suicide attempts.
    Correlation between values of clinical characteristics (hospitalizations) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Number of hospitalizations.
    Correlation between values of clinical characteristics (comorbid disorders) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    History and presence of comorbid disorders.
    Correlation between values of clinical characteristics (medication) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Medication load (in Chlorpromazine equivalent for antipsychotic medication, Chen&Davis).

    Full Information

    First Posted
    December 2, 2020
    Last Updated
    January 13, 2021
    Sponsor
    University Hospital, Grenoble
    Collaborators
    Commissariat A L'energie Atomique
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04703972
    Brief Title
    Identification of Predictive Biomarkers of Mood Relapses in Patients With Bipolar Disorder
    Acronym
    Predibip
    Official Title
    Identification of Predictive Biomarkers of Mood Relapses in Patients With Bipolar Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 13, 2021 (Anticipated)
    Primary Completion Date
    January 31, 2022 (Anticipated)
    Study Completion Date
    June 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Grenoble
    Collaborators
    Commissariat A L'energie Atomique

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bipolar Disorder

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Bipolar Patients with connected devices
    Arm Type
    Experimental
    Arm Description
    Patients with bipolar disorder provided with connected devices (wristwatch and wristband)
    Intervention Type
    Behavioral
    Intervention Name(s)
    clinical assessment (mood relapses identification)
    Other Intervention Name(s)
    physiological data monitoring
    Intervention Description
    clinical assessment via psychometric scales physiological data acquired automatically via the connected device (wristwatch, wristband)
    Primary Outcome Measure Information:
    Title
    Prediction of mood relapses
    Description
    number of relapses predicted by machine learning algorithms versus number of relapses highlighted by clinical assessment
    Time Frame
    at Month 6 of the follow-up
    Secondary Outcome Measure Information:
    Title
    Correlation between values of Heart rate variability and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Description
    Heart rate variability (HRV) (ms)
    Time Frame
    at Month 6 of the follow-up
    Title
    Correlation between values of skin surface temperature and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Description
    Physical parameters measured: Skin surface temperature in °C
    Time Frame
    at Month 6 of the follow-up
    Title
    Correlation between values of actimetry and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Description
    Physical parameters measured: Actimetry using accelerometer (movement per minute)
    Time Frame
    at Month 6 of the follow-up
    Title
    Correlation between ElectroDermal activity and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Description
    ElectroDermal activity (siemens)
    Time Frame
    at Month 6 of the follow-up
    Title
    Correlation between sleep periods and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Description
    Sleep periods
    Time Frame
    at Month 6 of the follow-up
    Title
    Correlation between social measures and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Description
    The internet connection times (minute), including social networks, the number and duration (minute) of telephone calls and the number and length (number of characters) of text messages will be automatically recorded daily in order to provide parameters that help quantify the patient's social activity.
    Time Frame
    at Month 6 of the follow-up
    Title
    Correlation between values of clinical characteristics (age of onset) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Description
    Age of onset (in years)
    Time Frame
    at Month 6 of the follow-up
    Title
    Correlation between values of clinical characteristics about thyme episode and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Description
    Predominant polarity (hypo/manic or depressive or without), polarity of last episode (hypo/manic or depressive), number of previous thymic episodes, duration of remission (in month).
    Time Frame
    at Month 6 of the follow-up
    Title
    Correlation between values of clinical characteristics (suicide attempts) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Description
    Number of suicide attempts.
    Time Frame
    at Month 6 of the follow-up
    Title
    Correlation between values of clinical characteristics (hospitalizations) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Description
    Number of hospitalizations.
    Time Frame
    at Month 6 of the follow-up
    Title
    Correlation between values of clinical characteristics (comorbid disorders) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Description
    History and presence of comorbid disorders.
    Time Frame
    at Month 6 of the follow-up
    Title
    Correlation between values of clinical characteristics (medication) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
    Description
    Medication load (in Chlorpromazine equivalent for antipsychotic medication, Chen&Davis).
    Time Frame
    at Month 6 of the follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mircea POLOSAN, MD-PhD
    Phone
    04 76 76 54 11
    Email
    MPolosan@chu-grenoble.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Arnaud Pouchon, MD
    Phone
    04 76 76 54 11
    Email
    APouchon@chu-grenoble.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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