AzTrials
AzTrials

DepressionDAF-PMIDNCT06565936

DPA-714 and FDG PET/MRI in Depression

A study testing PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG in people with Depression, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Depression, a common psychological disorder, is characterized by persistent low mood, loss of interest, and anhedonia, leading to significant dysfunctions and a high suicide risk. Read more about this study

Who is it for?
Ages 35 to 85 yearsHealthy volunteers can take part
Conditions the study is for
Depression
What is being tested?
PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
23 Aug 2024to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • For all groups :
  • No alcohol or psychoactive substances such as coffee had been consumed in the 24 hours prior to the examination
  • MMSE≥24 points,MOCA≥26 points
  • No anti-infective drugs in the past 1 month, no cold, fever or other infection history in the past 2 weeks
  • Patients with diabetes had fasting controlled below 9.0mmol/L before the examination
  • Volunteer to participate in the study and sign the informed consent
Show all 19Show fewer
  • For Recurrent depression patients:
  • Meet the Diagnostic criteria for recurrent major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
  • Age 35-85 years old, gender is not limited
  • HAMD≥8 points
  • For first episode depression Patients:
  • Gender, age and education level were matched with the recurrent depression group
  • Meet the Diagnostic criteria for the first episode of depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
  • HAMD≥8 points
  • For controls:
  • Healthy people undergoing "DPA-714 or FDG imaging PET/MRI" physical examination in PET/CT room of our hospital
  • Gender and education level were consistent with both the recurrent depression group and the first-episode depression group
  • never used any psychotropic drugs
  • HAMD<8 points;HAMA<7 points

Who cannot join

  • Have a history of organic mental disorders or other mental disorders
  • A family history of hereditary diseases
  • Persons with mental retardation or dementia
  • A history of psychoactive substance abuse
  • Can not cooperate with/complete the psychological examination scale
  • Previously found serious physical diseases (heart, brain, liver, lung and kidney)
Show all 10Show fewer
  • MRI contraindications, abnormalities found in head CT or MRI
  • A history of drug or alcohol abuse
  • Have a history of metabolic diseases such as hyperthyroidism, hypothyroidism,and rheumatic diseases
  • are in the state of pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • The First Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116000

    Hui min Zhang, +86 18098876233, huiminzhangxs@163.com

    Mei chen Liu, +86 18098871637, meichenliu9019@163.com

    Recruiting

Other trials in China

About this study

Official title: Clinical Application of DPA-714 and FDG PET/MRI Imaging in Patients With Depression

Depression, a common psychological disorder, is characterized by persistent low mood, loss of interest, and anhedonia, leading to significant dysfunctions and a high suicide risk. Its pathogenesis remains challenging, with recent focus on neuroinflammation-a chronic immune response in the central nervous system-as a potential contributor. PET imaging, using tracers like 18F-FDG and [18F]DPA-714, can visualize metabolic and neuroinflammatory changes. Combining these two tracers can explore the correlation between neuroinflammation and glucose metabolism in depression, further elucidating its possible mechanisms. We hypothesize that microglial activation in depression, especially in major gray matter regions of interest (prefrontal cortex, anterior cingulate cortex, and insula) and 12 additional regions and subregions, will show higher TSPO levels and increased glucose metabolism compared to the control group.

Read the detailed description

Depression is a common psychological disorder caused by various factors, characterized by significant and persistent low mood, loss of interest, and anhedonia as core symptoms, leading to physical, psychological, and social dysfunctions, with a high risk of suicide. The pathogenesis of depression remains a challenging topic in the medical field. Imaging studies are crucial for exploring the pathogenesis of depression. Recently, neuroinflammation has gained significant attention regarding the pathophysiological mechanisms of depression. Neuroinflammation, a chronic inflammatory response of the immune system in the central nervous system, may be related to the onset and progression of depression. PET is an imaging method that uses radioactive tracers to visualize physiological activities and metabolic processes in the body. 18F-FDG-PET can reflect neuronal degeneration and the reduction in the number and function of protrusions in vitro, directly indicating lesion sites and involvement. Therefore, PET/MRI brain metabolism imaging can uncover possible pathogenesis and explore unique brain network characteristics from a molecular imaging perspective. PET studies can depict local functional metabolism and neurochemical changes in the brain through radionuclide labeling. [18F]DPA-714, a PET tracer, is a high-affinity ligand for the translocator protein (TSPO), a mitochondrial outer membrane protein expressed in activated microglia and macrophages in the brain, serving as a marker of neuroinflammation. As a TSPO radioligand, DPA-714 can explore in vivo changes in neuroinflammation. Combining these two tracers can explore the correlation between neuroinflammation and glucose metabolism in depression, further elucidating its possible mechanisms.

This study will collect data from patients diagnosed with recurrent depression and first-episode depression in the Psychosomatic Sleep Department and Neurology Department of the First Affiliated Hospital of Dalian Medical University. Healthy individuals who underwent "DPA-714 or FDG imaging PET/MRI" physical examinations in the PET/CT room of our hospital will also be included. According to the inclusion and exclusion criteria, the groups will consist of 25 cases of recurrent depression, 25 cases of first-episode depression, and 20 healthy controls. Additionally, all three groups will undergo neuropsychological assessments, including Hamilton Anxiety Scale, Hamilton Depression Scale, Mini-mental State Examination, Montreal Cognitive Assessment, Pittsburgh Sleep Quality Index Scale, and other related cognitive, sleep, and emotional scales. We used DPA-714 imaging agent PET/MRI to scan the whole brain, selecting major gray matter regions of interest (prefrontal cortex, anterior cingulate cortex, and insula) and 12 additional regions and subregions to measure TSPO values. The patients with recurrent depression and first episode depression were compared with the normal control group to explore their characteristics. Moreover, through the relationship between TSPO values and neuropsychological scores, the correlation between TSPO values and depression severity was explored.

The statistical method we use is that SPSS26.0 statistical software (IBM, New York, United States) was used to conduct statistical analysis on the basic demographic data of each group. Normal test and homogeneity test of variance were performed on the data. Continuous variables conforming to normal distribution were expressed in the form of mean ± standard deviation (±s). Samples that do not conform to a normal distribution and variables represented as graded data are described by the median (interquartile range). The Chi-square test was used to compare categorical data groups. For normally distributed data, a two independent sample T-test was employed. Non-normally distributed data were analyzed using the Mann-Whitney U test. Pearson or Spearman correlation coefficients were used for correlation analysis, depending on the data distribution.

Conditions
Depression
Being tested
PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET scan with tracer injection [18F] DPA-714 or [18F]F-FDGRadiation

    Brain PET/MRI imaging will be conducted following the administration of [18F] DPA-714 or [18F]F-FDG. The radiopharmaceuticals are given intravenously in doses that are safe for the human body, with minimal quantities to reduce potential effects. Additionally, the irradiation levels are kept low, ensuring the procedure is safe and reliable for patients.

Study groups in NCT06565936
Study groupRoleWhat they receive
Recurrent depression patients groupExperimentalEvaluation of neuroinflammation and cerebral metabolism in the prefrontal cortex, anterior cingulate cortex, insula, and other brain regions of interest in patients with recurrent depression.
Receives: Radiation: PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG
First-episode depression patients groupExperimentalEvaluation of neuroinflammation and cerebral metabolism in the prefrontal cortex, anterior cingulate cortex, insula, and other brain regions of interest in patients with first episode depression.
Receives: Radiation: PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG
Healthy controls groupOtherEvaluation of neuroinflammation and cerebral metabolism in the prefrontal cortex, anterior cingulate cortex, insula, and other brain regions of interest in healthy controls.
Receives: Radiation: PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessment of baseline and follow up regional brain TSPO levels and cerebral metabolism using PET/MRI

    TSPO values for the major gray matter regions of interest (prefrontal cortex, anterior cingulate cortex, and insula) and 12 additional regions and subregions were observed in patients with recurrent and first-episode depression compared to controls.Estimates of brain TSPO concentrations measured with PET will serve as a marker for neuroinflammation. Variation of the regional cerebral glucose consumption and TSPO-PET measures will be compared between three groups.

    Measured: for 2 years

Secondary outcomes (5)
  1. Mini-Mental State Evaluation (MMSE)

    Clinician-administered screening tool used to systematically and thoroughly assess mental status through five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. Scores range between 0-30. A score of 25 or higher is classed as normal. If the score is below 24, the result is usually considered to be abnormal, indicating possible cognitive impairment.

    Measured: for 2 years

  2. Scores of Hamilton Depression Scale

    Using to assess depressive symptoms. With higher scores associated with more severe depression symptoms. Total scores <8 is normal; Mild depression with total scores of 8~17; Moderate depression with total scores of 18~24; Total scores >24 for severe depression.

    Measured: for 2 years

  3. Scores of Hamilton Anxiety Scale

    Using to assess anxiety symptoms. With higher scores associated with more severe anxiety symptoms. Total scores< 7 indicates no anxiety; Total scores≥7 indicates possible anxiety; Total scores≥14 indicates anxiety; Total scores≥21 indicates obvious anxiety; Total scores≥29 points indicates serious anxiety.

    Measured: for 2 years

  4. Pittsburgh Sleep Quality Index

    Using to assess the sleep quality. Total scores of 0-5 indicates that the quality of sleep is very good, 6~10 indicates that the quality of sleep is OK, 11~15 indicates that the quality of sleep is average, and 16~21 indicates that the quality of sleep is poor.

    Measured: for 2 years

  5. Correlation between microglial activation and cerebral metabolism in the prefrontal cortex, anterior cingulate cortex, insula, and other regions of interest, and the severity of disease in patients.

    Patients will be followed up longitudinally to monitor changes over time.

    Measured: for 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2024
  2. Study start23 Aug 2024
  3. Primary completionAug 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06565936
Sponsor's protocol ID
PJ-KS-KY-2024-153(X)
Acronym
DAF-PMID
Status last verified
Aug 2024
First submitted
20 Aug 2024
Last updated
12 Nov 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG in people with Depression, run by The First Affiliated Hospital of Dalian Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huimin Zhang (+86 18098876233, huiminzhangxs@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of baseline and follow up regional brain TSPO levels and cerebral metabolism using PET/MRI (time frame: for 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in