Belief Updating in Treatment Resistant Depression

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Oct 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how certain negative beliefs can affect people with treatment-resistant depression (TRD) and how these beliefs might change after receiving a new type of treatment called ketamine. Major depressive disorder (MDD) often leads individuals to have persistent negative thoughts about themselves and their future, which can make it hard for them to respond to traditional antidepressant medications. The researchers want to understand the brain activity related to these negative beliefs in patients before and after they start ketamine treatment, hoping to learn more about how this treatment can help improve their condition.

To participate in the trial, individuals need to be between 18 and 70 years old and have been diagnosed with major depressive disorder that hasn't responded to at least two different antidepressant treatments. They should not have other serious mental health conditions or certain medical issues that could complicate their participation, such as epilepsy or other brain disorders. If eligible, participants can expect to undergo brain scans and assessments to help researchers track changes in their beliefs and mood after starting the treatment. This study could provide valuable insights into how depression works and how new treatments like ketamine might help those who are struggling.

Gender

ALL

Eligibility 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: ADHD, personality disorder, schizophrenia, autism spectrum disorder, eating disorder, PTSD, social phobia, OCD, substance Use Disorder;
• • Inability to understand the task instructions and to perform the behavioral task
• • Mini Mental Score (MMS) ≤ 25
• • Antidepressant treatment involving dopaminergic agonists, triple reuptake inhibitors, and Monoamine oxidase inhibitors (MAOI)
• • Medical antecedents: epilepsy, brain tumor, nervous system disease, 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