Study on Neuropsychiatric Behavior in Cadmium-exposed People

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-08

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

FMT Treating Constipation Patients With Depression and/or Anxiety Symptoms - Clinical Efficacy and Potential Mechanisms

NCT03233100

Constipation - Functional Depressive Symptoms Anxiety Symptoms +1 more

UNKNOWN NA

The Study of Mindfulness-based Cognitive Therapy and Major Depressive Disorder

NCT03558256

Major Depressive Disorder

UNKNOWN NA

Effects of Non-drug Therapy on Cognitive Function in Healthy Individuals and Patients With First Episode Depression

NCT04503343

Depressive Disorder

COMPLETED NA

A Clinical Study Evaluating the Efficacy and Safety of CreNeuriS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder

NCT07295444

Mild Depressive Disorder Comorbid With Anxiety Disorder

ACTIVE_NOT_RECRUITING NA

Optimization of Diagnosis and Treatment of Depression Based on Multidimensional Clinical Assessment Classification

NCT04528628

Major Depressive Disorder

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will combine the research progress of the innovative drug GMDTC, the mechanism of nerve damage caused by Cd2+ disrupting Ca2+ homeostasis, imaging technology and analysis methods, and the basis of our previous research work to explore the effect of the chemical Class 1 innovative drug GMDTC on the neuropsychiatric behavior of people with excessive cadmium. mechanism of action. This study is not limited to the study of the mechanism of neurotoxicity after Cd2+ deposition. It will also clarify the clinical efficacy of the innovative drug GMDTC in removing Cd2+ deposition in the brain and reducing damage, which is expected to open up new avenues for the treatment of cadmium neurotoxicity. 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cadmium Exceeds the Standard

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cadmium exceeding standard group

The urine cadmium level exceeding 5 μg/g creatinine for two consecutive times.

Non-invasive examination and assessment.

Intervention Type OTHER

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.

healthy control group

Urine cadmium ≤ 5 μg/g creatinine.

Non-invasive examination and assessment.

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non-invasive examination and assessment.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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))

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes