Bipolar DisorderPredibipNCT04703972
Identification of Predictive Biomarkers of Mood Relapses in Patients With Bipolar Disorder
A study testing clinical assessment (mood relapses identification) in people with Bipolar Disorder, run by University Hospital, Grenoble.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- clinical assessment (mood relapses identification)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- clinical assessment (mood relapses identification)
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical assessment (mood relapses identification)Behavioural
Also called physiological data monitoring
clinical assessment via psychometric scales physiological data acquired automatically via the connected device (wristwatch, wristband)
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Patients with connected devices | Experimental | Patients with bipolar disorder provided with connected devices (wristwatch and wristband) Receives: Behavioral: clinical assessment (mood relapses identification) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of mood relapses
number of relapses predicted by machine learning algorithms versus number of relapses highlighted by clinical assessment
Measured: 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).
Heart rate variability (HRV) (ms)
Measured: 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).
Physical parameters measured: Skin surface temperature in °C
Measured: 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).
Physical parameters measured: Actimetry using accelerometer (movement per minute)
Measured: 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).
ElectroDermal activity (siemens)
Measured: 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).
Sleep periods
Measured: at Month 6 of the follow-up
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.
Measured: at Month 6 of the follow-up
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)
Measured: at Month 6 of the follow-up
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).
Measured: at Month 6 of the follow-up
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.
Measured: at Month 6 of the follow-up
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.
Measured: at Month 6 of the follow-up
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.
Measured: at Month 6 of the follow-up
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).
Measured: at Month 6 of the follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start13 Jan 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703972
- Sponsor's protocol ID
- 38RC20.087
- Acronym
- Predibip
- Status last verified
- May 2020
- First submitted
- 2 Dec 2020
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictive Biomarkers of Mood Relapses in Patients With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT04703972
- Acronym / sponsor ID
- Predibip / 38RC20.087
- Conditions
- Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Commissariat A L'energie Atomique
- Study start
- 13 Jan 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bipolar Patients with connected devices | Experimental | Behavioral: clinical assessment (mood relapses identification)Patients with bipolar disorder provided with connected devices (wristwatch and wristband) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical assessment (mood relapses identification)Also: physiological data monitoringclinical assessment via psychometric scales physiological data acquired automatically via the connected device (wristwatch, wristband) | Behavioural | Bipolar Patients with connected devices |
Primary outcome
Prediction of mood relapses
Time frame: at Month 6 of the follow-up
number of relapses predicted by machine learning algorithms versus number of relapses highlighted by clinical assessment
12 secondary outcomes
Correlation between values of Heart rate variability and the occurrence of a thymic relapse (number of relapses during the follow-up period).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: at Month 6 of the follow-up
Correlation between social measures and the occurrence of a thymic relapse (number of relapses during the follow-up period).
Time frame: at Month 6 of the follow-up
Correlation between values of clinical characteristics (age of onset) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
Time frame: at Month 6 of the follow-up
Correlation between values of clinical characteristics about thyme episode and the occurrence of a thymic relapse (number of relapses during the follow-up period).
Time frame: at Month 6 of the follow-up
Correlation between values of clinical characteristics (suicide attempts) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
Time frame: at Month 6 of the follow-up
Correlation between values of clinical characteristics (hospitalizations) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
Time frame: at Month 6 of the follow-up
Correlation between values of clinical characteristics (comorbid disorders) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
Time frame: at Month 6 of the follow-up
Correlation between values of clinical characteristics (medication) and the occurrence of a thymic relapse (number of relapses during the follow-up period).
Time frame: at Month 6 of the follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing clinical assessment (mood relapses identification) in people with Bipolar Disorder, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mircea POLOSAN, MD-PhD (04 76 76 54 11, MPolosan@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of mood relapses (time frame: at Month 6 of the follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.