Neuro-computational Study of Thymic Fluctuations in Mood Disorders
Recruiting · NCT07033923 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier St Anne
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
2 locations listed.
- Assistance Publique - Hôpitaux de Paris GH Pitié-Salpêtrière - Paris, France
- - Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences - Paris, Paris, France