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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
- 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
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 group | Role | What they receive |
|---|---|---|
| Recurrent depression patients group | Experimental | 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. Receives: Radiation: PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG |
| First-episode depression patients group | Experimental | 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. Receives: Radiation: PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG |
| Healthy controls group | Other | Evaluation 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.
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)
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
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
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
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
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.
- First posted22 Aug 2024
- Study start23 Aug 2024
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huimin Zhang, Principal investigator, The First Affiliated Hospital of Dalian Medical University
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of DPA-714 and FDG PET/MRI Imaging in Patients With Depression
- ClinicalTrials.gov ID
- NCT06565936
- Acronym / sponsor ID
- DAF-PMID / PJ-KS-KY-2024-153(X)
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Recurrent depression patients group | Experimental | Radiation: PET scan with tracer injection [18F] DPA-714 or [18F]F-FDGEvaluation of neuroinflammation and cerebral metabolism in the prefrontal cortex, anterior cingulate cortex, insula, and other brain regions of interest in patients with recurrent depression. |
| First-episode depression patients group | Experimental | Radiation: PET scan with tracer injection [18F] DPA-714 or [18F]F-FDGEvaluation 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. |
| Healthy controls group | Other | Radiation: PET scan with tracer injection [18F] DPA-714 or [18F]F-FDGEvaluation of neuroinflammation and cerebral metabolism in the prefrontal cortex, anterior cingulate cortex, insula, and other brain regions of interest in healthy controls. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- For all groups :
- For Recurrent depression patients:
- For first episode depression Patients:
- For controls:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET scan with tracer injection [18F] DPA-714 or [18F]F-FDGBrain 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. | Radiation | First-episode depression patients group, Healthy controls group, Recurrent depression patients group |
Primary outcome
Assessment of baseline and follow up regional brain TSPO levels and cerebral metabolism using PET/MRI
Time frame: for 2 years
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.
5 secondary outcomes
Mini-Mental State Evaluation (MMSE)
Time frame: for 2 years
Scores of Hamilton Depression Scale
Time frame: for 2 years
Scores of Hamilton Anxiety Scale
Time frame: for 2 years
Pittsburgh Sleep Quality Index
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.
Time frame: for 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huimin Zhang principal investigator
The First Affiliated Hospital of Dalian Medical University
1 site in 1 country: see every site and its status.
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.