PET Biomarker Study for Antidepressant Response Prediction in Major Depressive Disorder

NCT06452290 | Not Yet Recruiting

• 1 other identifier: 2024PI076
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Quantitative voxel-by-voxel analysis

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

  24 months

Secondary Outcomes (3)

• assessing the patient's acceptability of the imaging examination

  24 months

• Volumes and topographies of brain regions

  24 months

• Number of possible reclassification

  24 months

Study Arms (1)

Brain 18F-FDG PET-CT

EXPERIMENTAL

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

Device: brain 18F-FDG PET-CT

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.

Brain 18F-FDG PET-CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Véronique Roch

CONTACT

+33383154276; v.roch@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 5, 2025

Record last verified: 2025-06