AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Hu Shaohua, doctor contact

13957162903

dorhushaohua@zju.edu.cn

Fu Guanghui, doctor contact

18801170914

fuguanghui@zju.edu.cn

China1 site, 1 recruiting
  • Fu Guanghui

    Hangzhou, Zhejiang, 310000

    Fu Guanghui, doctor, 18801170914, fuguanghui@zju.edu.cn

    Lu Shaojia, doctor, 13777878093, ronaldo0319@163.com

    Recruiting

Other trials in China

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.

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 groups in NCT06109337
Study groupRoleWhat they receive
ADHD childrenTake peripheral blood 5ml; IQ and cognitive function test; Head MRI scan
Receives: Diagnostic Test: drow blood
typically developing controlsTake 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.

  1. 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

  2. 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

  3. 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)
  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.

  1. First posted31 Oct 2023
  2. Study start4 Dec 2023
  3. Primary completionMay 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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)
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 32219178
  • Darwish 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

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.

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