Neuro-computational look at mood fluctuations in depression and bipolar disorder.
Neuro-computational Study of Thymic Fluctuations in Mood Disorders - MOODELING
This tests whether combining brain scans, cognitive tests, and daily smartphone mood tracking can model and help predict mood changes in people with depression or bipolar disorder.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 588 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier St Anne Academic / other |
| Locations | 2 sites (Paris, Paris and 1 other locations) |
| Trial ID | NCT07033923 on ClinicalTrials.gov |
What this trial studies
The project combines a single neuroimaging session (structural and optional functional MRI) with computerized cognitive tests and a year of daily smartphone-based mood monitoring using a mobile application. Investigators will recruit three groups of about 96 participants each: people with depressive disorder, people with bipolar disorder, and healthy controls. Computational models will be fit to the behavioral and neural data to characterize how mood fluctuates and how those fluctuations relate to brain activity in regions such as the ventromedial prefrontal cortex and anterior insula. The main goal is to determine whether these models can describe real-life mood dynamics and predict subsequent clinical evolution.
Who should consider this trial
Good fit: Ideal candidates are adults with a recent (within 12 months) diagnosed depressive episode or a bipolar mood episode who can undergo MRI and commit to daily smartphone monitoring for up to 12 months.
Not a fit: People who cannot complete daily mobile monitoring for 12 months, are under legal guardianship, or have contraindications to MRI are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the approach could produce personalized tools that help clinicians predict mood episodes and tailor monitoring or treatment plans.
How similar studies have performed: Previous neurocomputational work and fMRI studies in healthy volunteers have linked mood signals to vmPFC and anterior insula activity, but translating these findings into clinically useful prediction tools remains largely unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Where this trial is running
Paris, Paris and 1 other locations
- - Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences — Paris, Paris, France (Recruiting)
- Assistance Publique - Hôpitaux de Paris GH Pitié-Salpêtrière — Paris, France (Recruiting)
Study contacts
- Principal investigator: Fabien Vinckier, Dr — GHU Paris Psychiatry & Neurosciences
- Study coordinator: Fabien Vinckier, Pr
- Email: F.VINCKIER@ghu-paris.fr
- Phone: (0) 1 45 65 84 52
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.