Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Recruiting Observational

Belief Updating in Treatment Resistant Depression

NCT05577247 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-05-13
Last updated
2026-04-13

Condition(s) studied

Treatment Resistant Depression

Investigational drug(s) / intervention(s)

functional magnetic resonance imaging

functional magnetic resonance imaging: Patients treated with ketamine antidepressants will be tested with fMRI before or 24h after a single ketamine infusion administered in the clinical setting.

Study summary

Major depressive disorder (MDD) is characterized by a cognitive triad of negative beliefs about oneself, the future and the world. For example, depressed patients hold persistently negative expectations about the future, despite contradictory evidence, and these strong negative beliefs are thought to play an important role in the maintenance of depressive symptoms and potentially in treatment resistance. Indeed, one out of three patients with major depressive disorder does not respond to conventional, monoaminergic treatments, which has led to the concept of treatment resistant depression (TRD). It is unknown how the brain encodes the strong negative beliefs that are insensitive to positive disconfirming information in TRD patients, and how these neural underpinnings of maladaptive belief updating are altered by antidepressant treatment.

The principal objective of this study is to gain insight into the brain mechanisms of belief updating about the future in TRD patients before and after starting ketamine treatment. The results of this study are expected to provide a better understanding of the neurocognitive mechanisms of belief-updating in depressed patients, and how these mechanisms contribute to clinical improvement following ketamine antidepressant treatment.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Blood oxygenation level dependant (BOLD) signal — 7 days
    BOLD signal measured with fMRI before or 24h after a single ketamine infusion

Trial sites (1)

FacilityCityRegionStatus
GH Pitié Salpêtrière Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05577247 on ClinicalTrials.gov ↗ ← All trials in France