ADHDNCT06109337
Immunoprofilling of Peripheral Blood Mononuclear Cells in Children With Attention Deficit/Hyperactivity Disorder
An observational study of ADHD and Immune System, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
The goal of this observational study is to learn about The immune cell landscape of peripheral blood mononuclear cells in children with ADHD compared to typically developing controls. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, Immune System, Clinical Syndrome
- What is being tested?
- drow blood
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 4 Dec 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children and teenagers ages 6-12 years
Who may be able to join
- Clinical diagnosis of ADHD; Children with an IQ≥70; Both parents are Han; Agree to take venous blood with informed consent;
Who cannot join
- Schizophrenia, mood disorder, autism, mental retardation; Obvious physical and nervous system abnormalities;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fu Guanghui
Hangzhou, Zhejiang, 310000
Fu Guanghui, doctor, 18801170914, fuguanghui@zju.edu.cn
Lu Shaojia, doctor, 13777878093, ronaldo0319@163.com
About this study
The goal of this observational study is to learn about The immune cell landscape of peripheral blood mononuclear cells in children with ADHD compared to typically developing controls. The main question it aims to answer are: 1.Testing the differences in immune cell subpopulations, protein expression and signaling pathways and cell subsets between two groups 2. Exploring the correlations between immune function in PBMC and resting-state brain functional networks in children with ADHD.
Participants will be taken peripheral blood about 5 ml , cognitive assessment including Intelligence testing, Stroop color-word test and Trail making test, clinical interview and brain structural and functional MRI.
Read the detailed description
3.1 Research Content Peripheral blood mononuclear cells of ADHD children and control group were taken, and 41 protein Marker on the cell surface was detected and analyzed by mass spectrometry flow cytometry (CyTOF) technology to draw a detailed map of ADHD immune cells, so as to explore the differences in protein expression level and subgroup distribution of immune cells between ADHD children and normal children. To evaluate the clinical symptoms, cognitive function, head MRI structure and resting state data of children with ADHD, and explore the correlation between immunophenotype and symptom score, cognition and brain structure.
3.2 Research Scheme 3.2.1 Collection of general and demographic data Demographic and clinical data, including name, age, sex, height, weight, age of first onset, course of disease, treatment, family history, past history and personal history, were collected by self-designed general situation scale.
3.2.2 Clinical evaluation The primary Clinical diagnosis was made by child psychiatrists with the title of attending psychiatrist or above through non-prescriptive clinical Interview, and the Clinical Diagnostic Interview Scale prepared by the American Working Group on Childhood Disorders was used. CDIS were conducted to evaluate ADHD classification, comorbidities, classification, comorbidities and clinical symptoms.
3.2.3 Core symptoms of ADHD ADHD-RS symptom assessment questionnaire was used to assess the severity of symptoms. The sum of scores of items in the attention deficit dimension is the attention deficit score, the sum of scores of items in the hyperactivity and impulsivity dimension is the score of hyperactivity impulse, and the sum of scores of all items is the score of the full scale. The higher the score, the more severe the symptoms.
3.2.4 Wechsler Intelligence test The Chinese children's Intelligence Scale (the third edition) was used to assess the IQ of the children.
3.2.5 Stroop color word naming test The test is divided into four parts. Part 1 asked the subjects to read red yellow green blue black character 6 Part 2 asked to name 30 red yellow green blue block colors; The third part requires reading 30 words whose meaning is inconsistent with the color of the print; Part 4 requires 30 read colors for word meaning and print color inconsistencies. The calculation indicators are: the completion time and the number of errors for each part. The results of part 1 and 2 reflect the ability of immediate attention; The time of Part 3 subtracts the time of Part 1 when the color interferes; The time of Part 4 minus the time of Part 2 is when the word is disturbed.
3.2.6 Trail making test (TMT) It is divided into A and B. In Formula A, the subjects were presented with numbers ranging from 1 to 25 randomly distributed, and were asked to connect the numbers accurately and quickly in an increasing order of 1-2-3 digits. The calculation measures the time and number of errors of the operation: reflects the visual spatial scanning and writing ability. In Formula B, the numbers 1-13 and letters A-L were distributed randomly and irregularly, and the subjects were required to accurately and quickly connect the numbers and letters in the cross order of 1-A-2-B-3-C. The calculation index was operation time and number of errors: the speed of reaction operation and the quality of completion. Use time B - time A: The ability to reflect the conversion of the subject.
3.2.7 The brain MRI structure and resting state data of subjects were collected High-resolution brain structure images were obtained using the Magnetization Prepared Rapid Acquisition Gradient-echo (MPRAGE) sequence with the following parameters: TR/TE= 7.1/2.9ms; sli-ces=146; Thickness =1 mm; Turnover Angle =8°; Matrix =256×256; Field of view =260×260 mm2; Voxel size 1*1*1mm.
Fmri images were collected by spin-echo-echo planar imaging (SE-EPI). The specific parameters were as follows: TR/TE=1800/30ms, section =28, thickness =4mm; Matrix =64×64, FOV=240×240 mm2, gap =0.8mm; Time point =180.
- Conditions
- ADHD, Immune System, Clinical Syndrome
- Being tested
- drow blood
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drow bloodDiagnostic test
Participants will be taken peripheral blood about 5 ml
| Study group | Role | What they receive |
|---|---|---|
| ADHD children | Take peripheral blood 5ml; IQ and cognitive function test; Head MRI scan Receives: Diagnostic Test: drow blood | |
| typically developing controls | Take peripheral blood 5ml; IQ and cognitive function test; Head MRI scan Receives: Diagnostic Test: drow blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
the differences in immune cell subpopulations, protein expression , signaling pathways between ADHD and typically developing children
Blood samples of ADHD patients and normal control groups were collected, peripheral blood mononuclear cells were extracted, and 41 protein markers on cell surface were detected and analyzed by CyTOF technology, and detailed atlas of ADHD immune cells were drawn for immunological index analysis. These indicators include cytokine levels, immune cell subsets, and immune-related gene expression.
Measured: 2023.11.1-2023.12.31 Participant recruitment and deta collections
Clinical assessment and cognitive function testing
The Clinical Diagnostic Interview Scale (CDIS) was used to evaluate ADHD types, comorbidities, types, comorbidities and clinical symptoms by child psychiatrists with the title of attending psychiatrist or above. ADHD-RS symptom assessment questionnaire was used to assess the severity of symptoms. Cognitive function tests include child IQ, Stroop color word naming test, and Trail making test (TMT).
Measured: 2023.11.1-2023.12.31 Participant recruitment and deta collections
Brain MRI structure and resting state data
High-resolution brain structure images were acquired using 3D Magnetization Prepared Rapid Acquisition Gradient-echo (MPRAGE).
The FMRI images were acquired by spin-echo-echo planar imaging (SE-EPI)
Measured: 2023.11.1-2023.12.31 Participant recruitment and deta collections
Secondary outcomes (1)
General and demographic data collection
A comprehensive questionnaire included name, age, sex, height, weight, age of first onset, course of disease, treatment, family history, past history, personal history
Measured: 2023.11.1-2023.12.31 data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start4 Dec 2023
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hu Guanghui, doctor, Principal investigator, Department of Psychiatry, the First Affiliated Hospital, Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109337
- Sponsor's protocol ID
- FirstZhejiangU-fgh01
- Status last verified
- Jan 2025
- First submitted
- 22 Oct 2023
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ni Chasaide C, Lynch MA. The role of the immune system in driving neuroinflammation. Brain Neurosci Adv. 2020 Jan 29;4:2398212819901082. doi: 10.1177/2398212819901082. eCollection 2020 Jan-Dec.
PubMed 32219178Darwish AH, Elgohary TM, Nosair NA. Serum Interleukin-6 Level in Children With Attention-Deficit Hyperactivity Disorder (ADHD). J Child Neurol. 2019 Feb;34(2):61-67. doi: 10.1177/0883073818809831. Epub 2018 Nov 15.
PubMed 30430896
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunoprofilling of Peripheral Blood Mononuclear Cells in Children With Attention Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT06109337
- Acronym / sponsor ID
- FirstZhejiangU-fgh01
- Conditions
- ADHD, Immune System, Clinical Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about The immune cell landscape of peripheral blood mononuclear cells in children with ADHD compared to typically developing controls. The main question it aims to answer are: 1.Testing the differences in immune cell subpopulations, protein expression and signaling pathways and cell subsets between two groups 2. Exploring the correlations between immune function in PBMC and resting-state brain functional networks in children with ADHD.
Participants will be taken peripheral blood about 5 ml , cognitive assessment including Intelligence testing, Stroop color-word test and Trail making test, clinical interview and brain structural and functional MRI.
Detailed description
3.1 Research Content Peripheral blood mononuclear cells of ADHD children and control group were taken, and 41 protein Marker on the cell surface was detected and analyzed by mass spectrometry flow cytometry (CyTOF) technology to draw a detailed map of ADHD immune cells, so as to explore the differences in protein expression level and subgroup distribution of immune cells between ADHD children and normal children. To evaluate the clinical symptoms, cognitive function, head MRI structure and resting state data of children with ADHD, and explore the correlation between immunophenotype and symptom score, cognition and brain structure.
3.2 Research Scheme 3.2.1 Collection of general and demographic data Demographic and clinical data, including name, age, sex, height, weight, age of first onset, course of disease, treatment, family history, past history and personal history, were collected by self-designed general situation scale.
3.2.2 Clinical evaluation The primary Clinical diagnosis was made by child psychiatrists with the title of attending psychiatrist or above through non-prescriptive clinical Interview, and the Clinical Diagnostic Interview Scale prepared by the American Working Group on Childhood Disorders was used. CDIS were conducted to evaluate ADHD classification, comorbidities, classification, comorbidities and clinical symptoms.
3.2.3 Core symptoms of ADHD ADHD-RS symptom assessment questionnaire was used to assess the severity of symptoms. The sum of scores of items in the attention deficit dimension is the attention deficit score, the sum of scores of items in the hyperactivity and impulsivity dimension is the score of hyperactivity impulse, and the sum of scores of all items is the score of the full scale. The higher the score, the more severe the symptoms.
3.2.4 Wechsler Intelligence test The Chinese children's Intelligence Scale (the third edition) was used to assess the IQ of the children.
3.2.5 Stroop color word naming test The test is divided into four parts. Part 1 asked the subjects to read red yellow green blue black character 6 Part 2 asked to name 30 red yellow green blue block colors; The third part requires reading 30 words whose meaning is inconsistent with the color of the print; Part 4 requires 30 read colors for word meaning and print color inconsistencies. The calculation indicators are: the completion time and the number of errors for each part. The results of part 1 and 2 reflect the ability of immediate attention; The time of Part 3 subtracts the time of Part 1 when the color interferes; The time of Part 4 minus the time of Part 2 is when the word is disturbed.
3.2.6 Trail making test (TMT) It is divided into A and B. In Formula A, the subjects were presented with numbers ranging from 1 to 25 randomly distributed, and were asked to connect the numbers accurately and quickly in an increasing order of 1-2-3 digits. The calculation measures the time and number of errors of the operation: reflects the visual spatial scanning and writing ability. In Formula B, the numbers 1-13 and letters A-L were distributed randomly and irregularly, and the subjects were required to accurately and quickly connect the numbers and letters in the cross order of 1-A-2-B-3-C. The calculation index was operation time and number of errors: the speed of reaction operation and the quality of completion. Use time B - time A: The ability to reflect the conversion of the subject.
3.2.7 The brain MRI structure and resting state data of subjects were collected High-resolution brain structure images were obtained using the Magnetization Prepared Rapid Acquisition Gradient-echo (MPRAGE) sequence with the following parameters: TR/TE= 7.1/2.9ms; sli-ces=146; Thickness =1 mm; Turnover Angle =8°; Matrix =256×256; Field of view =260×260 mm2; Voxel size 1*1*1mm.
Fmri images were collected by spin-echo-echo planar imaging (SE-EPI). The specific parameters were as follows: TR/TE=1800/30ms, section =28, thickness =4mm; Matrix =64×64, FOV=240×240 mm2, gap =0.8mm; Time point =180.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD children | – | Diagnostic Test: drow bloodTake peripheral blood 5ml; IQ and cognitive function test; Head MRI scan |
| typically developing controls | – | Diagnostic Test: drow bloodTake peripheral blood 5ml; IQ and cognitive function test; Head MRI scan |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children and teenagers ages 6-12 years
Key inclusion criteria (1 listed)
- Clinical diagnosis of ADHD; Children with an IQ≥70; Both parents are Han; Agree to take venous blood with informed consent;
Key exclusion criteria (1 listed)
- Schizophrenia, mood disorder, autism, mental retardation; Obvious physical and nervous system abnormalities;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| drow bloodParticipants will be taken peripheral blood about 5 ml | Diagnostic test | ADHD children, typically developing controls |
Primary outcome
the differences in immune cell subpopulations, protein expression , signaling pathways between ADHD and typically developing children
Time frame: 2023.11.1-2023.12.31 Participant recruitment and deta collections
Blood samples of ADHD patients and normal control groups were collected, peripheral blood mononuclear cells were extracted, and 41 protein markers on cell surface were detected and analyzed by CyTOF technology, and detailed atlas of ADHD immune cells were drawn for immunological index analysis. These indicators include cytokine levels, immune cell subsets, and immune-related gene expression.
Clinical assessment and cognitive function testing
Time frame: 2023.11.1-2023.12.31 Participant recruitment and deta collections
The Clinical Diagnostic Interview Scale (CDIS) was used to evaluate ADHD types, comorbidities, types, comorbidities and clinical symptoms by child psychiatrists with the title of attending psychiatrist or above. ADHD-RS symptom assessment questionnaire was used to assess the severity of symptoms. Cognitive function tests include child IQ, Stroop color word naming test, and Trail making test (TMT).
Brain MRI structure and resting state data
Time frame: 2023.11.1-2023.12.31 Participant recruitment and deta collections
High-resolution brain structure images were acquired using 3D Magnetization Prepared Rapid Acquisition Gradient-echo (MPRAGE). The FMRI images were acquired by spin-echo-echo planar imaging (SE-EPI)
1 secondary outcome
General and demographic data collection
Time frame: 2023.11.1-2023.12.31 data collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Results publication: PubMed 32219178Ni Chasaide C, Lynch MA. The role of the immune system in driving neuroinflammation. Brain Neurosci Adv. 2020 Jan 29;4:2398212819901082. doi: 10.1177/2398212819901082. eCollection 2020 Jan-Dec.
- Results publication: PubMed 30430896Darwish AH, Elgohary TM, Nosair NA. Serum Interleukin-6 Level in Children With Attention-Deficit Hyperactivity Disorder (ADHD). J Child Neurol. 2019 Feb;34(2):61-67. doi: 10.1177/0883073818809831. Epub 2018 Nov 15.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hu Guanghui, doctor principal investigator
Department of Psychiatry, the First Affiliated Hospital, Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD and Immune System, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hu Shaohua, doctor (13957162903, dorhushaohua@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the differences in immune cell subpopulations, protein expression , signaling pathways between ADHD and typically developing children (time frame: 2023.11.1-2023.12.31 Participant recruitment and deta collections). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06109337, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.