Understanding how belief changes in treatment resistant depression
How the Brain Encodes Beliefs: A Functional Magnetic Resonance Imaging Study of the Belief Updating in Treatment Resistant Depression.
This study is trying to see how a single dose of antidepressant treatment can change negative beliefs about the future in people with treatment-resistant depression by looking at their brain activity.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05577247 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the brain mechanisms involved in belief updating among patients with treatment resistant depression (TRD). It focuses on how these patients encode negative beliefs about the future and how these beliefs may change after receiving a single dose of an antidepressant treatment. Using functional magnetic resonance imaging (fMRI), the study will measure brain activity in response to positive and negative information before and after treatment. The findings could provide insights into the cognitive biases that contribute to TRD and inform future therapeutic strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 who have been diagnosed with major depressive disorder and have not responded to at least two different antidepressant treatments.
Not a fit: Patients with other mental disorders or those unable to understand task instructions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment approaches for patients suffering from treatment resistant depression.
How similar studies have performed: While the study explores novel aspects of belief updating in TRD, similar studies have shown promise in understanding cognitive biases in depression.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Demographic criteria: * Age: 18 to 70 years * Male et female Diagnostic criteria, severity and clinical course: * Major depressive disorder (MDD) according to the DSM5 criteria * MADRS≥20, * Treatment resistant depression (TRD) defined by failure to respond to at least two trials of different antidepressant treatments * affiliation of a social security regime Treatments/strategies/procedures: o At the start of new antidepressant treatment involving glutamate receptor modulators. Exclusion criteria: Criteria relating to associated pathologies carrying specific risks: * Mental disorder other than MDD: personality disorder type borderline, schizophrenia * Inability to understand the task instructions and to perform the behavioral task * Mini Mental Score (MMS) ≤ 25 * Antidepressant treatment involving dopaminergic agonists, and Monoamine oxidase inhibitors (MAOI) * Neurological comorbidities : epilepsy, brain tumor, non-corrected visual and/or auditory deficit Criteria associated with contraindications/procedures/interventions added by the research: o Contra-indications for an MRI exam (metallic implant, pacemaker, artificial heart valve, brain vascular malformation, aneurysm clips, exposed by metallic fragments, artificial implants, peripheral or neuronal stimulator, insulin pump, intravenous catheter, epilepsy, metallic contraceptive device, claustrophobia, unwillingness to be informed in case of abnormal MRI (with a significant medical anomaly)) Criteria relating to vulnerable populations: * Pregnancy * Patient on AME (state medical aid) * Patient under guardianship, curators or legal protection
Where this trial is running
Paris
- GH Pitié Salpêtrière — Paris, France (Recruiting)
Study contacts
- Study coordinator: Philippe FOSSATI, PUPH
- Email: philippe.fossati@aphp.fr
- Phone: +33142162891
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.