Neuro-computational look at mood fluctuations in depression and bipolar disorder.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• - 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.