Attention-Deficit/Hyperactivity Disorder (ADHD)NCT07800117
Investigation of the Association of Multimodal Neuroimaging and Peripheral Biomarkers With Executive Functions and Emotional Regulation in Adolescents With Attention-Deficit/Hyperactivity Disorder
An observational study of Attention-Deficit/Hyperactivity Disorder (ADHD), run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this observational study is to investigate the relationships among resting-state brain connectivity, peripheral blood biomarkers, executive functions, and emotional regulation in adolescents with attention-deficit/hyperactivity disorder (ADHD). Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder (ADHD)
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 31 Jan 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The study population will consist of 80 participants aged 10-18 years, including 40 adolescents diagnosed with attention-deficit/hyperactivity disorder (ADHD) according to DSM-5 criteria and 40 healthy controls. Participants in the ADHD group will be recruited from the Child and Adolescent Psychiatry outpatient clinic of Akdeniz University Hospital. Healthy controls will be recruited from the General Pediatrics outpatient clinic of Akdeniz University Hospital. The groups will be matched for sex. All participants will have clinically normal intellectual capacity (IQ >80) and be predominantly right-handed. Participants with acute or chronic inflammatory diseases or other specified exclusion criteria will not be included.
Who may be able to join
- Age 10-18 years, including ages 10 and 18.
- Diagnosis of attention-deficit/hyperactivity disorder (ADHD) according to DSM-5 criteria.
- Clinically normal intellectual capacity (IQ >80).
- Predominantly right-handed.
- No acute or chronic inflammatory disease.
- Healthy Control Group:
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- Age 10-18 years, including ages 10 and 18.
- No psychiatric diagnosis according to DSM-5 criteria.
- Clinically normal intellectual capacity (IQ >80).
- Predominantly right-handed.
- No acute or chronic inflammatory disease.
Who cannot join
- Age younger than 10 or older than 18 years.
- Intellectual disability (IQ <80).
- Hydrocephalus or herniation.
- Predominantly left-handed.
- History of possible traumatic brain injury.
- Current or past neurological or serious medical disease (e.g., epilepsy).
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- Autism spectrum disorder.
- Psychotic disorder.
- Mood disorder.
- Conduct disorder.
- Active anxiety disorder or substance use disorder.
- Presence of an acute or chronic inflammatory disease.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Faculty of Medicine Hospital
Antalya
About this study
The purpose of this observational study is to investigate the relationships among resting-state brain connectivity, peripheral blood biomarkers, executive functions, and emotional regulation in adolescents with attention-deficit/hyperactivity disorder (ADHD). The study will include 40 adolescents aged 10 to 18 years with ADHD and 40 age- and sex-matched healthy controls. Participants will undergo clinical and psychological assessments, resting-state functional magnetic resonance imaging, and blood sampling. Serum levels of BDNF, cortisol, IL-1α, IFN-γ, TNF-α, and IL-6 will be measured. The study will examine whether differences in brain connectivity and biomarker levels are associated with executive functioning and emotional regulation.
Read the detailed description
Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by difficulties in attention, hyperactivity, and impulsivity. Although alterations in neural networks and peripheral biological processes have been investigated separately, the relationships among functional brain connectivity, peripheral biomarkers, executive functions, and emotional regulation in adolescents with ADHD remain incompletely understood.
The primary aim of this study is to investigate the relationships among resting-state functional brain connectivity, peripheral serum biomarkers, executive functions, and emotional regulation in adolescents with ADHD and to compare these findings with those of healthy controls. The study will focus particularly on resting-state functional connectivity within and between brain networks, including the default mode network (DMN), executive control network (ECN), and salience network (SN).
The study will include adolescents aged 10 to 18 years with ADHD and age- and sex-matched healthy controls. Participants will undergo standardized clinical and psychological assessments, resting-state functional magnetic resonance imaging (fMRI), and peripheral blood sampling. Serum concentrations of brain-derived neurotrophic factor (BDNF), cortisol, interleukin-1 alpha (IL-1α), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-γ) will be measured using enzyme-linked immunosorbent assay (ELISA).
Executive functioning, emotional regulation, behavioral characteristics, and clinical symptoms will be assessed using standardized clinical and behavioral assessment instruments. Resting-state fMRI data will be processed using standard preprocessing procedures, including motion correction, coregistration, normalization, smoothing, denoising, and band-pass filtering. Functional connectivity analyses will be conducted using independent component analysis and/or seed-based correlation approaches.
The study will examine whether alterations in resting-state functional connectivity and peripheral biomarker levels differ between adolescents with ADHD and healthy controls and whether these biological measures are associated with executive functioning, emotional regulation, and clinical characteristics. Associations among functional connectivity measures, serum biomarkers, and behavioral and clinical scores will also be investigated.
The study is designed to contribute to a more comprehensive understanding of the neurobiological mechanisms underlying ADHD in adolescence by integrating neuroimaging, peripheral biological, and behavioral measures.
- Being tested
- No Intervention
- Keywords
- ADHD, Peripheral Biomarkers, Functional Connectivity, Emotional Regulation, Executive Functions, Resting-State Functional MRI
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is an observational study. No intervention or treatment is assigned to participants. Participants are assessed using clinical and neuropsychological assessments, resting-state functional magnetic resonance imaging, and peripheral blood biomarker measurements.
| Study group | Role | What they receive |
|---|---|---|
| ADHD | Adolescents aged 10 to 18 years (including ages 10 and 18) who have been diagnosed with attention-deficit/hyperactivity disorder (ADHD) according to DSM-5 criteria and who are not receiving any medication treatment will be included in this group. Participants will have clinically normal intellectual capacity (IQ >80), be predominantly right-handed, and have no acute or chronic inflammatory disease. A total of 40 participants with ADHD will be included. Participants will undergo clinical and neuropsychological assessments, resting-state functional magnetic resonance imaging, and venous blood sampling for serum biomarker analysis. Receives: Other: No Intervention | |
| Healthy Control Group | Healthy adolescents aged 10 to 18 years (including ages 10 and 18) without a psychiatric diagnosis according to DSM-5 criteria will be included in this group. Participants will have clinically normal intellectual capacity (IQ >80), be predominantly right-handed, and have no acute or chronic inflammatory disease. Participants will be age- and sex-matched with the ADHD group. A total of 40 healthy control participants will be included. Participants will undergo clinical and neuropsychological assessments, resting-state functional magnetic resonance imaging, and venous blood sampling for serum biomarker analysis. The same exclusion criteria applied to the ADHD group will also apply to the healthy control group. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting-State Functional Connectivity Within and Between the Default Mode Network and Other Brain Networks
Resting-state functional magnetic resonance imaging (fMRI) will be used to assess functional connectivity within the Default Mode Network (DMN) and between the DMN and other brain networks. Functional connectivity measures will be compared between adolescents with attention-deficit/hyperactivity disorder and healthy controls.
Measured: At the baseline assessment
Secondary outcomes (3)
Serum BDNF, Cortisol, IL-1α, IL-6, TNF-α, and IFN-γ Levels
Serum levels of brain-derived neurotrophic factor (BDNF), cortisol, interleukin-1 alpha (IL-1α), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-γ) will be measured and compared between adolescents with attention-deficit/hyperactivity disorder (ADHD) and healthy controls.
Measured: At the baseline assessment
Executive Functioning Measured by the Behavior Rating Inventory of Executive Function (BRIEF)
Executive functioning will be assessed using the Behavior Rating Inventory of Executive Function (BRIEF). Executive functioning scores will be examined in relation to resting-state functional connectivity and serum biomarker levels.
Measured: At the baseline assessment
Emotion Regulation Difficulties Measured by the Difficulties in Emotion Regulation Scale
Emotion regulation difficulties will be assessed using the Difficulties in Emotion Regulation Scale. Scores will be examined in relation to resting-state functional connectivity and serum biomarker levels.
Measured: At the baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start1 Mar 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit/Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by Akdeniz 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
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hicran Doğru, MD, Principal investigator, Akdeniz UniversityKadir Tunçer, MD, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800117
- Sponsor's protocol ID
- TTU-2026-7133
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Association of Multimodal Neuroimaging and Peripheral Biomarkers With Executive Functions and Emotional Regulation in Adolescents With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT07800117
- Acronym / sponsor ID
- TTU-2026-7133
- Keywords
- ADHD, Peripheral Biomarkers, Functional Connectivity, Emotional Regulation, Executive Functions, Resting-State Functional MRI
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 2 Sep 2026 (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 purpose of this observational study is to investigate the relationships among resting-state brain connectivity, peripheral blood biomarkers, executive functions, and emotional regulation in adolescents with attention-deficit/hyperactivity disorder (ADHD). The study will include 40 adolescents aged 10 to 18 years with ADHD and 40 age- and sex-matched healthy controls. Participants will undergo clinical and psychological assessments, resting-state functional magnetic resonance imaging, and blood sampling. Serum levels of BDNF, cortisol, IL-1α, IFN-γ, TNF-α, and IL-6 will be measured. The study will examine whether differences in brain connectivity and biomarker levels are associated with executive functioning and emotional regulation.
Detailed description
Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by difficulties in attention, hyperactivity, and impulsivity. Although alterations in neural networks and peripheral biological processes have been investigated separately, the relationships among functional brain connectivity, peripheral biomarkers, executive functions, and emotional regulation in adolescents with ADHD remain incompletely understood.
The primary aim of this study is to investigate the relationships among resting-state functional brain connectivity, peripheral serum biomarkers, executive functions, and emotional regulation in adolescents with ADHD and to compare these findings with those of healthy controls. The study will focus particularly on resting-state functional connectivity within and between brain networks, including the default mode network (DMN), executive control network (ECN), and salience network (SN).
The study will include adolescents aged 10 to 18 years with ADHD and age- and sex-matched healthy controls. Participants will undergo standardized clinical and psychological assessments, resting-state functional magnetic resonance imaging (fMRI), and peripheral blood sampling. Serum concentrations of brain-derived neurotrophic factor (BDNF), cortisol, interleukin-1 alpha (IL-1α), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-γ) will be measured using enzyme-linked immunosorbent assay (ELISA).
Executive functioning, emotional regulation, behavioral characteristics, and clinical symptoms will be assessed using standardized clinical and behavioral assessment instruments. Resting-state fMRI data will be processed using standard preprocessing procedures, including motion correction, coregistration, normalization, smoothing, denoising, and band-pass filtering. Functional connectivity analyses will be conducted using independent component analysis and/or seed-based correlation approaches.
The study will examine whether alterations in resting-state functional connectivity and peripheral biomarker levels differ between adolescents with ADHD and healthy controls and whether these biological measures are associated with executive functioning, emotional regulation, and clinical characteristics. Associations among functional connectivity measures, serum biomarkers, and behavioral and clinical scores will also be investigated.
The study is designed to contribute to a more comprehensive understanding of the neurobiological mechanisms underlying ADHD in adolescence by integrating neuroimaging, peripheral biological, and behavioral measures.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD | – | Other: No InterventionAdolescents aged 10 to 18 years (including ages 10 and 18) who have been diagnosed with attention-deficit/hyperactivity disorder (ADHD) according to DSM-5 criteria and who are not receiving any medication treatment will be included in this group. Participants will have clinically normal intellectual capacity (IQ >80), be predominantly right-handed, and have no acute or chronic inflammatory disease. A total of 40 participants with ADHD will be included. Participants will undergo clinical and neuropsychological assessments, resting-state functional magnetic resonance imaging, and venous blood sampling for serum biomarker analysis. |
| Healthy Control Group | – | Other: No InterventionHealthy adolescents aged 10 to 18 years (including ages 10 and 18) without a psychiatric diagnosis according to DSM-5 criteria will be included in this group. Participants will have clinically normal intellectual capacity (IQ >80), be predominantly right-handed, and have no acute or chronic inflammatory disease. Participants will be age- and sex-matched with the ADHD group. A total of 40 healthy control participants will be included. Participants will undergo clinical and neuropsychological assessments, resting-state functional magnetic resonance imaging, and venous blood sampling for serum biomarker analysis. The same exclusion criteria applied to the ADHD group will also apply to the healthy control group. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population will consist of 80 participants aged 10-18 years, including 40 adolescents diagnosed with attention-deficit/hyperactivity disorder (ADHD) according to DSM-5 criteria and 40 healthy controls. Participants in the ADHD group will be recruited from the Child and Adolescent Psychiatry outpatient clinic of Akdeniz University Hospital. Healthy controls will be recruited from the General Pediatrics outpatient clinic of Akdeniz University Hospital. The groups will be matched for sex. All participants will have clinically normal intellectual capacity (IQ >80) and be predominantly right-handed. Participants with acute or chronic inflammatory diseases or other specified exclusion criteria will not be included.
Key inclusion criteria (11 listed)
- Age 10-18 years, including ages 10 and 18.
- Diagnosis of attention-deficit/hyperactivity disorder (ADHD) according to DSM-5 criteria.
- Clinically normal intellectual capacity (IQ >80).
- Predominantly right-handed.
- No acute or chronic inflammatory disease.
Key exclusion criteria (12 listed)
- Age younger than 10 or older than 18 years.
- Intellectual disability (IQ <80).
- Hydrocephalus or herniation.
- Predominantly left-handed.
- History of possible traumatic brain injury.
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 |
|---|---|---|
| No InterventionThis is an observational study. No intervention or treatment is assigned to participants. Participants are assessed using clinical and neuropsychological assessments, resting-state functional magnetic resonance imaging, and peripheral blood biomarker measurements. | Other | ADHD, Healthy Control Group |
Primary outcome
Resting-State Functional Connectivity Within and Between the Default Mode Network and Other Brain Networks
Time frame: At the baseline assessment
Resting-state functional magnetic resonance imaging (fMRI) will be used to assess functional connectivity within the Default Mode Network (DMN) and between the DMN and other brain networks. Functional connectivity measures will be compared between adolescents with attention-deficit/hyperactivity disorder and healthy controls.
3 secondary outcomes
Serum BDNF, Cortisol, IL-1α, IL-6, TNF-α, and IFN-γ Levels
Time frame: At the baseline assessment
Executive Functioning Measured by the Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: At the baseline assessment
Emotion Regulation Difficulties Measured by the Difficulties in Emotion Regulation Scale
Time frame: At the baseline assessment
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 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Hicran Doğru, MD principal investigator
Akdeniz University
Kadir Tunçer, MD study director
Akdeniz University
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 Attention-Deficit/Hyperactivity Disorder (ADHD), run by Akdeniz University at 1 site in Turkey (Türkiye).
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 11 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting-State Functional Connectivity Within and Between the Default Mode Network and Other Brain Networks (time frame: At the baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2026.