An interventional study of PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG in Depression, sponsored by The First Affiliated Hospital of Dalian Medical University. Recruiting at 1 site in China. Open to participants aged 35 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-12.
Sponsored by The First Affiliated Hospital of Dalian Medical University · Not applicable, Interventional, and Diagnostic
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.
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.
8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.
This study's planned enrollment of 70 is below the median of 81 across 7,063 interventional studies indexed under Depression.
Browse Depression studies →The First Affiliated Hospital of Dalian Medical University is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For all groups :
For Recurrent depression patients:
For first episode depression Patients:
For controls:
Exclusion Criteria(for all groups):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Evaluation of neuroinflammation and cerebral metabolism in the prefrontal cortex, anterior cingulate cortex, insula, and other brain regions of interest in patients with recurrent depression.
Radiation: PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG
Evaluation 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.
Radiation: PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG
Evaluation of neuroinflammation and cerebral metabolism in the prefrontal cortex, anterior cingulate cortex, insula, and other brain regions of interest in healthy controls.
Radiation: PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG
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.
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 years
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 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: for 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Aug 2026, 24 months after the start.
Of 3,468 non-industry interventional studies with no phase under Depression, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's planned 24 months is above that.
Counting every sponsor, half of 3,566 studies reached it within 21 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
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The First Affiliated Hospital of Dalian Medical University