PET Biomarker Study for Antidepressant Response Prediction in Major Depressive Disorder
PET Scan for Depression Treatment Prediction
Plain English Summary
PET Biomarker Study for Antidepressant Response Prediction in Major Depressive Disorder is a Not Applicable clinical trial sponsored by Central Hospital, Nancy, France studying Major Depressive Disorder. This trial uses a special scan to predict how well antidepressants will work for people with depression. It’s for adults with depression who are about to start taking a type of antidepressant called SSRIs. Participants will have a brain scan and then take the antidepressant to see if it works well. There are other ways to predict treatment response, but this trial aims to find a more accurate method. The trial aims to enroll 30 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older, have depression, and are planning to take SSRIs. You cannot join if you have certain neurological or psychiatric conditions or if you are not covered by a health scheme. The trial is for adults only. Good health is required, but specific health conditions must be absent. This trial is studying Major Depressive Disorder, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see if a special brain scan can predict how well a type of antidepressant will work for people with depression. The specific primary outcome measures are: Quantitative voxel-by-voxel analysis (24 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial is important because it could help doctors predict which antidepressants will work best for patients with depression, improving treatment outcomes. This research targets Major Depressive Disorder, where improved treatment options are needed.
Investor Insight
The market for depression treatments is large, and this trial could fill a significant gap by providing a more accurate way to predict treatment response.
Is This Trial Right for Me?
Ask your doctor if you are eligible for the study and if the brain scan is safe for you. On the day of the scan, you will need to fast for a few hours and may need to avoid certain medications. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 30 participants
Interventions
- 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.
Primary Outcomes
- Quantitative voxel-by-voxel analysis (24 months)
Secondary Outcomes
- 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)
Full Eligibility Criteria
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
Frequently Asked Questions
What is clinical trial NCT06452290?
NCT06452290 is a Not Applicable INTERVENTIONAL study titled "PET Biomarker Study for Antidepressant Response Prediction in Major Depressive Disorder." It is currently not yet recruiting and is sponsored by Central Hospital, Nancy, France. The trial targets enrollment of 30 participants.
What conditions does NCT06452290 study?
This trial investigates treatments for Major Depressive Disorder. The primary condition under study is Major Depressive Disorder.
What treatments are being tested in NCT06452290?
The interventions being studied include: 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.
What does Not Applicable mean for NCT06452290?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06452290?
This trial is currently "Not Yet Recruiting." It started on 2026-09-01. The estimated completion date is 2029-03-01.
Who is sponsoring NCT06452290?
NCT06452290 is sponsored by Central Hospital, Nancy, France. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06452290?
The trial aims to enroll 30 participants. The trial has not yet started recruiting.
How is NCT06452290 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT06452290?
The primary outcome measures are: Quantitative voxel-by-voxel analysis (24 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT06452290?
The official record for NCT06452290 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06452290. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06452290 testing in simple terms?
This trial uses a special scan to predict how well antidepressants will work for people with depression. It’s for adults with depression who are about to start taking a type of antidepressant called SSRIs.
Why is this trial significant?
This trial is important because it could help doctors predict which antidepressants will work best for patients with depression, improving treatment outcomes.
What are the potential risks of participating in NCT06452290?
There is a small risk of side effects from the brain scan, including allergic reactions to the tracer used in the scan. The scan involves radiation, so it is important to discuss any concerns with your doctor. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06452290?
Ask your doctor if you are eligible for the study and if the brain scan is safe for you. On the day of the scan, you will need to fast for a few hours and may need to avoid certain medications. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06452290 signal from an investment perspective?
The market for depression treatments is large, and this trial could fill a significant gap by providing a more accurate way to predict treatment response. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will have a brain scan and then take the antidepressant to see if it works well. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Major Depressive Disorder Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.