Investigating the effects of cadmium exposure on mental health
Study on the Mechanism of Action of Chemical Category 1 Innovative Drug GMDTC on Neuropsychiatric Behavior in Cadmium-exposed People
This study is testing whether a new drug can help people who have been exposed to cadmium feel better mentally by removing the cadmium from their brains.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd. Industry-sponsored |
| Locations | 1 site (Changsha, Hunan) |
| Trial ID | NCT06572566 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between excessive cadmium exposure and neuropsychiatric behaviors, including clinical pain, depression, and cognitive impairment. It will utilize innovative drug GMDTC to assess its efficacy in removing cadmium from the brain and mitigating associated neurotoxic effects. The study will employ non-invasive examinations and advanced imaging technologies to analyze the impact of cadmium on mental health and the potential benefits of treatment. Participants will be monitored for changes in neuropsychiatric indicators following cadmium elimination.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with elevated urinary cadmium levels and no significant neurodevelopmental or organic brain disorders.
Not a fit: Patients with pre-existing serious clinical diseases or neurodevelopmental disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment options for individuals suffering from neuropsychiatric issues related to cadmium exposure.
How similar studies have performed: While the approach of using GMDTC is innovative, the relationship between cadmium exposure and neuropsychiatric effects has been explored in other studies, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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))
Where this trial is running
Changsha, Hunan
- Hunan Occupational Disease Prevention and Control Institute — Changsha, Hunan, China (Recruiting)
Study contacts
- Principal investigator: Fang Pei — Hunan Occupational Disease Prevention and Control Institute
- Study coordinator: Xiaojiang Tang, PhD
- Email: river-t@126.com
- Phone: 13719282259
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.