Study on Neuropsychiatric Behavior in Cadmium-exposed People

April 16, 2026 updated by: Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.

Study on the Mechanism of Action of Chemical Category 1 Innovative Drug GMDTC on Neuropsychiatric Behavior in Cadmium-exposed People

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Xiaojiang Tang, PhD
  • Phone Number: 13719282259
  • Email: river-t@126.com

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410000
        • Hunan Occupational Disease Prevention and Control Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The subjects were recruited from the cadmium-excessive group at the Hunan Provincial Occupational Disease Prevention and Control Hospital from January 2024 to June 2024, and healthy volunteers were recruited from the outpatient clinic. It is planned to include 42 cases of people with excessive cadmium and 42 cases of healthy people.

Description

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))

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cadmium exceeding standard group
The urine cadmium level exceeding 5 μg/g creatinine for two consecutive times.
Other: 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.
healthy control group
Urine cadmium ≤ 5 μg/g creatinine.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cadmium load
Time Frame: Baseline, after 2 weeks, after 6 weeks
To comprehensively assess the urinary cadmium levels in volunteers, blood cadmium and urinary cadmium levels were measured at different time points.
Baseline, after 2 weeks, after 6 weeks
MATRICS Consensus Cognitive Battery (MCCB)
Time Frame: Baseline, after 2 weeks, after 6 weeks
The internationally recognized MATRICS Consensus Cognitive Battery (MCCB) for objective assessment of cognitive function.Cognitive scores for all individuals will be calculated using the MCCB software, yielding corrected scores for each test as well as an overall cognitive score.
Baseline, after 2 weeks, after 6 weeks
The Hamilton Depression Rating Scale (HAMD)
Time Frame: Baseline, after 2 weeks, after 6 weeks
mental and psychological status was assessed with the Hamilton Depression Rating Scale (HAMD).The scale will include the unabbreviated scale title, the minimum and maximum values, and higher scores mean a worse outcome.
Baseline, after 2 weeks, after 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
One of the early indicators of kidney injury--β2-MG
Time Frame: Baseline, after 2 weeks, after 6 weeks
β2-microglobulin(β2-MG).Clinically, the measurement of β2-MG concentration in urine provides an early, reliable, and sensitive indicator for assessing renal function and diagnosing cadmium toxicity.
Baseline, after 2 weeks, after 6 weeks
Hamilton Anxiety Scale（HAMA）
Time Frame: Baseline, after 2 weeks, after 6 weeks
The HAMA scale will be used to assess the anxiety levels of volunteers, with higher scores indicating more severe anxiety.
Baseline, after 2 weeks, after 6 weeks
One of the early indicators of kidney injury--NAG
Time Frame: Baseline, after 2 weeks, after 6 weeks
N-acetyl-β-D-glucosaminidase,NAG. Urinary N-acetyl-beta-D-glucosaminidase (NAG) activity is one of the sensitive and specific indicators for renal tubular lesions and can serve as an early diagnostic marker for tubular damage, even providing earlier predictive value than urinary albumin.
Baseline, after 2 weeks, after 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fang Pei, Hunan Occupational Disease Prevention and Control Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • JianerShengPharmaNI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings