Study on Neuropsychiatric Behavior in Cadmium-exposed People
Study on the Mechanism of Action of Chemical Category 1 Innovative Drug GMDTC on Neuropsychiatric Behavior in Cadmium-exposed People
Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.
84 participants
Jan 8, 2024
OBSERVATIONAL
Conditions
Summary
This study hypothesized that excessive cadmium is related to clinical pain, depression, and cognitive impairment, and that related indicators will improve after cadmium is eliminated.
Eligibility
Inclusion Criteria5
- Age ≥18 years old, both men and women are welcome
- The weight of male subjects is ≥50.0 kg, the weight of female subjects is ≥45.0 kg, and the body mass index (BMI) is between 19 \~ 26 kg/m2, including the critical value
- Urinary cadmium \>5 μmol/mol creatinine for 2 consecutive days (creatinine content is ≥0.3 μg/L and ≤3 μg/L)
- Right-handed
- Voluntarily participate in this study and sign informed consent.
Exclusion Criteria7
- Combined with other neurodevelopmental problems (such as autism), organic brain mental disorders (such as Alzheimer\'s disease, Parkinson\'s disease, etc.) and organic brain diseases (such as cerebral hemorrhage, infarction, etc.) that meet the DSM-5 diagnostic criteria )
- Those who have suffered from or are currently suffering from any serious clinical diseases that pose safety risks such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormalities
- Continuous use of high-dose neuroleptics in the past 3 months (high-dose: daily dosage of benzodiazepines ≥ 4 mg lorazepam equivalent; long-term: the total duration of use is at least 60 days)
- Have contraindications for MRI or bone density examination (pacemaker or defibrillator, artificial heart valve, clothing containing fluorescein, iron, etc.)
- Pregnant and lactating women
- Those who cannot tolerate venipuncture and/or have a history of fainting from blood or needles
- Those with eGFR \<30 mL/min/1.73 m2 during screening (eGFR is calculated using the Cockcroft-Gault formula: eGFR(mL/min/1.73m2) = (140-age)\*weight (kg)/\[0.818\*Cr(μmol/L )\]\*0.85(female))
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Interventions
1\) Test the blood and urine components of all subjects to evaluate the damage to kidney function caused by excessive cadmium. 2) Conduct MRI examinations on all subjects to evaluate changes in brain functional connectivity, metabolism, and structure after excessive cadmium exposure. 3) Conduct bone density examinations on all subjects to evaluate changes in bone density after excessive cadmium exposure. (3) Clinical psychiatric assessment: All subjects will be assessed on their mental and psychological conditions such as pain, cognitive function, depression, anxiety, mania, sleep quality, and suicide risk.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06572566