Neuro-computational Study of Thymic Fluctuations in Mood Disorders
MOODELING
1 other identifier
interventional
588
1 country
2
Brief Summary
Depression and bipolar disorder are frequent, debilitating conditions. Both are thought to be primarily caused by an impaired regulation of mood, which is why they are sometimes referred to as "mood disorders". However, the biological basis of mood remains poorly understood, which is a major limitation for the development of new treatments. Recent work that combines neuroscience with mathematical models are promising to better understand mood and to link it to its biological basis, but they don't have any medical application yet. Can these models describe mood in a way that is relevant to mood disorders, and help doctors and psychologists predict subsequent clinical evolution? With the objective of extending this framework to real-life fluctuations and to assess its clinical relevance, this study will combine a neuroimaging session with a smartphone-based, longitudinal follow-up. Three groups of 96 subjects each will be recruited: depressive disorder, bipolar disorder and healthy controls. They will have their mood fluctuations assessed first in the lab (in the neuroimaging experiment), then in their daily lives (by providing a few ratings and choices every day on the smartphone app). This study will allow to better understand the differences in how patients' mood reacts to daily events, as compared to people who don't suffer from depression or bipolar disorder. The combination of the two steps will allow to assess whether a short neuroimaging evaluation can be useful to predict subsequent clinical evolution during the following months. The investigators wanted to add two optional ancillary studies. The first uses a mobile application for implicit, passive, and longitudinal mood assessments through emotion tracking. Indeed, it seems relevant to add this type of evaluation alongside explicit assessments to more accurately detect mood fluctuations. The second study uses a mobile application that allows voice recordings. The analysis of these vocal parameters will help to characterize a specific linguistic and vocal profile within the three groups, as well as to identify specific symptoms of conditions such as depression and bipolar disorder. These ancillary studies will be offered to both patients and the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Jul 2024
Longer than P75 for not_applicable depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 18, 2024
CompletedFirst Submitted
Initial submission to the registry
February 26, 2025
CompletedFirst Posted
Study publicly available on registry
June 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 18, 2029
June 24, 2025
June 1, 2025
4 years
February 26, 2025
June 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Computational phenotypes of daily mood fluctuations in the 3 groups
Computational phenotypes of daily mood fluctuations obtained from daily collection of mood data and daily life events via the mobile application.
From enrolment to Month 12
Secondary Outcomes (7)
Short-term computational phenotypes of mood
Month 0
Correlation of computational phenotypes of mood at short and long-term
From enrollment to Month 12
Basal fMRI signal characteristics of the vmPFC and aIns in each group
Month 0
Neural correlates from functional MRI (fMRI)
Month 0
Effect of mood on decision-making at short and long-term
From enrolment to Month 12
- +2 more secondary outcomes
Study Arms (1)
BD Group: patients with bipolar disorder
EXPERIMENTALPatients with: * a diagnosis of bipolar mood disorder (F31) according to ICD-10 criteria, made by a psychiatrist * a thymic episode (F31.0 - F31.6) diagnosed in the past 12 months by a psychiatrist
Interventions
Brain MRI with structural (anatomical) and functional sequences (without contrast injection) will be collected. The cognitive tests will be carried out during the recording of the functional MRI (optional) in order to highlight the neural correlates of mood variations.
Cognitive tests can be administered during the recording of a functional MRI, in order to highlight the neural correlates of mood variations. Cognitive data from a computerized experimental psychology experiment: this test involves different tests on a computer or tablet, including a test evaluating the minimal variations in the subject's mood and motivational state during the task, as well as its decision-making abilities.
Daily longitudinal monitoring by mobile MOODELING application (mood, energy, events) with self-monitoring tools (calendar, mood curve) at home. Follow-up duration on the application: 12 months
Eligibility Criteria
You may qualify if:
- Common between groups (DD, BD, control and GP):
- Having given informed and written consent
- Being covered by social security
- For patients with depressive disorder (DD):
- Having been diagnosed with characterized depressive episode (F32, F33, F34) according to the ICD-10, by a psychiatrist, or having presented this diagnosis during the past 12 months
- For patients with bipolar disorder (BD):
- Presenting a diagnosis of bipolar mood disorder (F31) according to ICD-10, by a psychiatrist
- Having presented a mood episode (F31.0 - F31.6) diagnosed during the past 12 months by a psychiatrist
You may not qualify if:
- Common between groups (DD, BD, control and GP):
- Inability to carry out daily monitoring on mobile application for 12 months
- legal protection measure (guardianship or curatorship)
- For control group:
- Current diagnosis of psychiatric disorder in ICD-10 (F20-F98) or prescription of psychotropic treatment
- History of depression (F32)
- Syndrome of dependence on a psychoactive substance other than tobacco
- Neurological history (in particular history of stroke, coma, epilepsy, neuro- inflammatory, or neuro-degenerative disease)
- Inability to carry out daily monitoring on mobile application for 12 months
- For patients and healthy volunteers for whom an MRI (without injection of contrast agent) is proposed
- Contraindication to MRI: cardiac pacemaker not compatible with MRI, heart valve implant, implant or metallic foreign body
- Pregnant woman (at the time of MRI)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
- Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences
Paris, Paris, 75014, France
Assistance Publique - Hôpitaux de Paris GH Pitié-Salpêtrière
Paris, 75651, France
Related Publications (7)
Rutledge RB, Moutoussis M, Smittenaar P, Zeidman P, Taylor T, Hrynkiewicz L, Lam J, Skandali N, Siegel JZ, Ousdal OT, Prabhu G, Dayan P, Fonagy P, Dolan RJ. Association of Neural and Emotional Impacts of Reward Prediction Errors With Major Depression. JAMA Psychiatry. 2017 Aug 1;74(8):790-797. doi: 10.1001/jamapsychiatry.2017.1713.
PMID: 28678984BACKGROUNDEldar E, Rutledge RB, Dolan RJ, Niv Y. Mood as Representation of Momentum. Trends Cogn Sci. 2016 Jan;20(1):15-24. doi: 10.1016/j.tics.2015.07.010. Epub 2015 Nov 3.
PMID: 26545853BACKGROUNDEldar E, Niv Y. Interaction between emotional state and learning underlies mood instability. Nat Commun. 2015 Jan 21;6:6149. doi: 10.1038/ncomms7149.
PMID: 25608088BACKGROUNDHeerema R, Carrillo P, Daunizeau J, Vinckier F, Pessiglione M. Mood fluctuations shift cost-benefit tradeoffs in economic decisions. Sci Rep. 2023 Oct 24;13(1):18173. doi: 10.1038/s41598-023-45217-w.
PMID: 37875525BACKGROUNDPessiglione M, Heerema R, Daunizeau J, Vinckier F. Origins and consequences of mood flexibility: a computational perspective. Neurosci Biobehav Rev. 2023 Apr;147:105084. doi: 10.1016/j.neubiorev.2023.105084. Epub 2023 Feb 9.
PMID: 36764635BACKGROUNDVinckier F, Rigoux L, Oudiette D, Pessiglione M. Neuro-computational account of how mood fluctuations arise and affect decision making. Nat Commun. 2018 Apr 26;9(1):1708. doi: 10.1038/s41467-018-03774-z.
PMID: 29700303BACKGROUNDRutledge RB, Skandali N, Dayan P, Dolan RJ. A computational and neural model of momentary subjective well-being. Proc Natl Acad Sci U S A. 2014 Aug 19;111(33):12252-7. doi: 10.1073/pnas.1407535111. Epub 2014 Aug 4.
PMID: 25092308BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabien Vinckier, Dr
GHU Paris Psychiatry & Neurosciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2025
First Posted
June 24, 2025
Study Start
July 18, 2024
Primary Completion (Estimated)
July 18, 2028
Study Completion (Estimated)
July 18, 2029
Last Updated
June 24, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- The data obtained from medical visits (clinical informations, biological assessments, neurocognitive data)and brain MRIs will be kept, coded and archived for a period of two years after the last publication of the research results or until the final research report is signed.
- Access Criteria
- The data can be used for collaborative research (academic and/or industrial partners) in the European Union (EU) and/or abroad exclusively for scientific purposes. Any party must contact the sponsor, who has full property of the data. In case of requested transfer of the anonymized database resulting from this research abroad (outside the EU), the sponsor will request information regarding data storage and management, to make sure that the other party will be able to ensure a level of security equivalent to French or European Union law.
The data obtained from medical visits (clinical informations, biological assessments, cognitive data) and brain MRIs will be kept, coded and archived for a period of two years after the last publication of the research results or until the final research report is signed. These can be used later for collaborative research (academic and/or industrial partners) in the European Union (EU) and/or abroad exclusively for scientific purposes.