Understanding how belief changes in treatment resistant depression

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

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.

Why it matters

Who can join: the full rules

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 it's running

• GH Pitié Salpêtrière
  Paris, France Recruiting

Study contacts

• Study coordinator: Philippe FOSSATI, PUPH
• Email: philippe.fossati@aphp.fr
• Phone: +33142162891

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.