Study on Neuropsychiatric Behavior in Cadmium-exposed People

NCT06572566 | Completed

• 1 other identifier: JianerShengPharmaNI
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cadmium Exceeds the Standard

Keywords

cadmium; Cadmium exceeds the standard; neuropsychiatric behavior; neuroimaging; cognitive impairment

Outcome Measures

Primary Outcomes (3)

• Cadmium load

  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)

  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)

  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 Outcomes (3)

• One of the early indicators of kidney injury--β2-MG

  Baseline, after 2 weeks, after 6 weeks

• Hamilton Anxiety Scale（HAMA）

  Baseline, after 2 weeks, after 6 weeks

• One of the early indicators of kidney injury--NAG

  Baseline, after 2 weeks, after 6 weeks

Study Arms (2)

Cadmium exceeding standard group

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

Other: Non-invasive examination and assessment.

healthy control group

Urine cadmium ≤ 5 μg/g creatinine.

Other: Non-invasive examination and assessment.

Interventions

Non-invasive examination and assessment. 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.

Cadmium exceeding standard group; healthy control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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))

Sponsors & Collaborators

• Jianersheng (Zhuhai) Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

Hunan Occupational Disease Prevention and Control Institute

Changsha, Hunan, 410000, China

Location

Related Publications (3)

• Clemens S, Aarts MG, Thomine S, Verbruggen N. Plant science: the key to preventing slow cadmium poisoning. Trends Plant Sci. 2013 Feb;18(2):92-9. doi: 10.1016/j.tplants.2012.08.003. Epub 2012 Sep 12.

  PMID: 22981394 BACKGROUND

• Deng D, Xu C, Sun P, Wu J, Yan C, Hu M, Yan N. Crystal structure of the human glucose transporter GLUT1. Nature. 2014 Jun 5;510(7503):121-5. doi: 10.1038/nature13306. Epub 2014 May 18.

  PMID: 24847886 BACKGROUND

• Mergenthaler P, Lindauer U, Dienel GA, Meisel A. Sugar for the brain: the role of glucose in physiological and pathological brain function. Trends Neurosci. 2013 Oct;36(10):587-97. doi: 10.1016/j.tins.2013.07.001. Epub 2013 Aug 20.

  PMID: 23968694 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Fang Pei

  Hunan Occupational Disease Prevention and Control Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 27, 2024
• Study Start: January 8, 2024
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)