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NCT Number: NCT06452290

PET Biomarker Study for Antidepressant Response Prediction in Major Depressive Disorder

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Quantitative voxel-by-voxel analysis

    Time frame: 24 months

    Quantitative voxel-by-voxel analysis of cerebral glycolytic metabolism on a group scale

Secondary outcomes

  1. assessing the patient's acceptability of the imaging examination

    Time frame: 24 months

    satisfaction survey

  2. Volumes and topographies of brain regions

    Time frame: 24 months

    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.

  3. Number of possible reclassification

    Time frame: 24 months

    Number of possible reclassification of response to Selective Serotonin Reuptake Inhibitors, by adding 18F-FDG brain PET/CT to electroretinogram

Study contacts

Contact information is provided by the study sponsor or research team.

Véronique Roch

CONTACT

[email protected]

+33383154276

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: TEPDEP

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jun 11, 2024
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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