Study on Neuropsychiatric Behavior in Cadmium-exposed People
- Conditions
- Cadmium Exceeds the Standard
- Registration Number
- NCT06572566
- Lead Sponsor
- Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 84
Inclusion Criteria:<br><br> - Age =18 years old, both men and women are welcome<br><br> - The weight of male subjects is =50.0 kg, the weight of female subjects is =45.0 kg,<br> and the body mass index (BMI) is between 19 ~ 26 kg/m2, including the critical value<br><br> - Urinary cadmium >5 µmol/mol creatinine for 2 consecutive days (creatinine content<br> is =0.3 µg/L and =3 µg/L)<br><br> - Right-handed<br><br> - Voluntarily participate in this study and sign informed consent.<br><br>Exclusion Criteria:<br><br> - Combined with other neurodevelopmental problems (such as autism), organic brain<br> mental disorders (such as Alzheimer's disease, Parkinson's disease, etc.)<br> and organic brain diseases (such as cerebral hemorrhage, infarction, etc.) that meet<br> the DSM-5 diagnostic criteria )<br><br> - Those who have suffered from or are currently suffering from any serious clinical<br> diseases that pose safety risks such as circulatory system, endocrine system,<br> nervous system, digestive system, respiratory system, hematology, immunology,<br> psychiatry and metabolic abnormalities<br><br> - Continuous use of high-dose neuroleptics in the past 3 months (high-dose: daily<br> dosage of benzodiazepines = 4 mg lorazepam equivalent; long-term: the total duration<br> of use is at least 60 days)<br><br> - Have contraindications for MRI or bone density examination (pacemaker or<br> defibrillator, artificial heart valve, clothing containing fluorescein, iron, etc.)<br><br> - Pregnant and lactating women<br><br> - Those who cannot tolerate venipuncture and/or have a history of fainting from blood<br> or needles<br><br> - Those with eGFR <30 mL/min/1.73 m2 during screening (eGFR is calculated using the<br> Cockcroft-Gault formula: eGFR(mL/min/1.73m2) = (140-age)weight<br> (kg)/[0.818Cr(µmol/L )]*0.85(female))
Not provided
Study & Design
- Study Type
- Observational [Patient Registry]
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cadmium load;McGill Pain Questionnaire Short Form (MPQ);MATRICS Consensus Cognitive Battery (MCCB);The Hamilton Depression Rating Scale (HAMD)
- Secondary Outcome Measures
Name Time Method One of the early indicators of kidney injury--ß2-MG;Hamilton Anxiety Scale(HAMA);One of the early indicators of kidney injury--NAG