RecruitingNot ApplicableNCT07033923

Neuro-computational Study of Thymic Fluctuations in Mood Disorders

Neuro-computational Study of Thymic Fluctuations in Mood Disorders - MOODELING


Sponsor

Centre Hospitalier St Anne

Enrollment

588 participants

Start Date

Jul 18, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how mood fluctuations in people with depression or bipolar disorder relate to brain activity and decision-making — using brain imaging and computer-based thinking tasks to understand the biology of mood changes. **You may be eligible if...** (For patients) - You have been diagnosed with a depressive disorder, bipolar disorder, general psychiatric symptoms, or are a healthy volunteer - You have experienced a relevant mood episode in the past 12 months - You are covered by social security - You have given written informed consent **You may NOT be eligible if...** - You are not able to give consent - You do not fit into one of the target groups (depression, bipolar disorder, or healthy control) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBrain magnetic resonance imaging (MRI) with structural (anatomical) and functional sequences (optional)

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.

BEHAVIORALComputerized cognitive tests

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.

DEVICEDaily longitudinal monitoring by mobile MOODELING application

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


Locations(2)

- Groupe hospitalo-universitaire Paris Psychiatrie et Neurosciences

Paris, Paris, France

Assistance Publique - Hôpitaux de Paris GH Pitié-Salpêtrière

Paris, France

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NCT07033923


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