PET Biomarker Study for Antidepressant Response Prediction in Major Depressive Disorder (TEPDEP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: brain 18F-FDG PET-CT

Detailed Description

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 as a biomarker for predicting and monitoring therapeutic response.

In the literature, numerous studies have shown a pattern of carbohydrate hypometabolism characteristic of depression, identified by 18F-FDG brain PET/CT scans. Cerebral metabolism patterns predictive of antidepressant response have also been demonstrated in some clinical trials, with hypermetabolism of the anterior cingulate in responders; and more severe hypometabolism of the anterior cingulate , dorsolateral prefrontal cortex and premotor area in non-responders. However, the studies in the literature group together very heterogeneous populations, with a large proportion of patients not naïve to antidepressant treatment.

The TEPDEP study described in this protocol would evaluate Positons Eission Tomography (PET) with flurodeoxyglucose labelled with fluor-18 (18F-FDG) brain 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Véronique Roch; Phone Number: +33383154276; Email: v.roch@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient aged 18 and over, included in the MESANTIDEP study for whom SSRI ( Selective serotonin reuptake inhibitor) treatment is planned.
• Patient who has received full information on the organization of the research and has given written informed consent (or a third person, independent of the investigator and sponsor, in the event of inability to read or write),
• Patient affiliated to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

• Contraindications for 18F-FDG PET/CT scans
• Presence of chronic neurological or psychiatric pathologies pre-Covid-19

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brain 18F-FDG PET-CT; The strategy under investigation is a medical device: a PET/CT scanner using the radiopharmaceutical 18F-FDG.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative voxel-by-voxel analysis	Quantitative voxel-by-voxel analysis of cerebral glycolytic metabolism on a group scale	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessing the patient's acceptability of the imaging examination	satisfaction survey	24 months
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
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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Major depressive disorder , PET-CT , nuclear medicine
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Fluorodeoxyglucose F18
• Other Study ID Numbers: 2024PI076

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No