PET Biomarker Study for Antidepressant Response Prediction in Major Depressive Disorder

Sponsor
Central Hospital, Nancy, France
Study ID
NCT06452290
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • brain 18F-FDG PET-CT — DEVICE
    PET scanner, Philips VEREOS PET/CT scanner. Three Philips VEREOS digital PET/CT scanners are installed in the nuclear medicine department.

Study Details

Major depressive disorder has a prevalence of 4.7% in the general population and is ranked as the leading cause of disability worldwide. The efficacy of current antidepressants is limited, as 50-60% of patients do not achieve a sufficient response to treatment : 12% achieve only a partial response, while 19-34% do not respond at all. These uncertain clinical effects are only observed after several weeks of treatment. For better patient management, there is an urgent need to identify markers for predicting and monitoring therapeutic response. Psychiatrists at the Nancy Psychotherapeutic Center are about to launch a "MESANTIDEP" study, in which they will evaluate the electroretinogram (ERG) as a biomarker for predicting and monitoring therapeutic response. The TEPDEP study described in this protocol would evaluate 18F-FDG brain PET/CT as a biomarker for predicting antidepressant response in a treatment-naive patient population. It is planned to offer the PET/CT study to patients included in the SSRI arm of the MesantiDEP study. The hypothesis of this study is that 18F-FDG PET/CT could be a biomarker for predicting response to selective serotonin reuptake inhibitor (SSRI) antidepressants.

Key Dates

First listed
Jun 11, 2024
Start date
Sep 1, 2026
Status verified
Jun 2025
Primary completion
Sep 1, 2028
Completion
Mar 1, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Brain 18F-FDG PET-CT
    The strategy under investigation is a medical device: a PET/CT scanner using the radiopharmaceutical 18F-FDG.

Primary Outcome Measure

Quantitative voxel-by-voxel analysis [ Time Frame: 24 months ]

Central Contacts

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