DPA-714 and FDG PET/MRI in Depression
NCT Number: NCT06565936
Acronym: DAF-PMID
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Depression
Interventions: RADIATION: PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG
Sponsor: The First Affiliated Hospital of Dalian Medical University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-08
Completion Date: 2026-12
Locations: The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning, 116000, China

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. 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.

Primary Outcome Measures: 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., for 2 years
Secondary Outcome Measures: 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., for 2 years|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., for 2 years|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., for 2 years|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., for 2 years|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., for 2 years