DPA-714 and FDG PET/MRI in Depression
ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-85
SponsorThe First Affiliated Hospital of Dalian Medical University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG
RadiationBrain 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.
Treatment groups
70 Participants
are divided into 3 treatment groupsGroup A: Recurrent depression patients groupExperimental treatment 1 intervention
Group B: First-episode depression patients groupExperimental treatment 1 intervention
Group C: Healthy controls groupOther 1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
for 2 yearsSecondary outcomes
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.
Time frame
for 2 years2
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.
Time frame
for 2 years3
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.
Time frame
for 2 years4
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.
Time frame
for 2 yearsSponsors and contacts
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Source ClinicalTrials.gov