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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06452290
Other study ID # 2024PI076
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2024
Est. completion date March 1, 2027

Study information

Verified date June 2024
Source Central Hospital, Nancy, France
Contact Véronique Roch
Phone +33383154276
Email v.roch@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Outcome

Type Measure Description Time frame Safety issue
Primary Quantitative voxel-by-voxel analysis Quantitative voxel-by-voxel analysis of cerebral glycolytic metabolism on a group scale 24 months
Secondary assessing the patient's acceptability of the imaging examination satisfaction survey 24 months
Secondary Volumes and topographies of brain regions Volumes and topographies of brain regions , defined as those showing decreased glycolytic metabolism in 18F-FDG brain PET/CT in relation to quantitative electroretinogram parameters. 24 months
Secondary Number of possible reclassification Number of possible reclassification of response to Selective Serotonin Reuptake Inhibitors, by adding 18F-FDG brain PET/CT to electroretinogram 24 months
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