DPA-714 and FDG PET/MRI in Depression

NCT06565936 | Recruiting

• 1 other identifier: PJ-KS-KY-2024-153(X)
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Outcome Measures

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.

  for 2 years

Secondary Outcomes (5)

• Mini-Mental State Evaluation (MMSE)

  for 2 years

• Scores of Hamilton Depression Scale

  for 2 years

• Scores of Hamilton Anxiety Scale

  for 2 years

• Pittsburgh Sleep Quality Index

  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.

  for 2 years

Study Arms (3)

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.

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.

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.

Radiation: PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG

Interventions

PET scan with tracer injection [18F] DPA-714 or [18F]F-FDG RADIATION

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.

First-episode depression patients group; Healthy controls group; Recurrent depression patients group

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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:

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116000, China

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Magnetic Resonance Spectroscopy; Product Labeling; N,N-diethyl-2-(2-(4-(2-fluoroethoxy)phenyl)-5,7-dimethylpyrazolo(1,5-a)pyrimidin-3-yl)acetamide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Product Packaging; Industry; Technology, Industry, and Agriculture

Study Officials

• Huimin Zhang

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huimin Zhang

CONTACT

+86 18098876233; huiminzhangxs@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: August 23, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)