Belief Updating in Treatment Resistant Depression

NCT05577247 | Recruiting

• 2 other identifiers: APHP2206042022-A01961-42
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Treatment Resistant Depression

Keywords

Treatment resistant depression; belief updating; fMRI; ketamine

Outcome Measures

Primary Outcomes (1)

• Blood oxygenation level dependant (BOLD) signal

  BOLD signal measured with fMRI before or 24h after a single ketamine infusion

  7 days

Secondary Outcomes (3)

• Belief updating behavioral measure

  7 days

• Montgomery Asberg depression rating scale score,

  7 days

• prognostic expectancy rating of antidepressant efficacy

  7 days

Study Arms (2)

Before antidepressant treatment

Other: functional magnetic resonance imaging

After antidepressant treatment

Other: functional magnetic resonance imaging

Interventions

functional magnetic resonance imaging OTHER

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

After antidepressant treatment; Before antidepressant treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with treatment resistant depression (TRD)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

GH Pitié Salpêtrière

Paris, France

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Philippe FOSSATI, PUPH

CONTACT

+33142162891; philippe.fossati@aphp.fr

Liane Schmidt, PhD

CONTACT

33157274374; liane.schmidt@icm-institute.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: October 13, 2022
• Study Start: May 13, 2024
• Primary Completion (Estimated): December 13, 2026
• Study Completion (Estimated): December 13, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

FR (1)