ClinicalTrials.gg
Active, not recruitingNCT07800117Updated Sep 2, 2026

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 in Attention-Deficit/Hyperactivity Disorder (ADHD), sponsored by Akdeniz University. Active, not recruiting at 1 site in Turkey (Türkiye). Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by Akdeniz University · Observational

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Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
80
Ages
10 Years to 18 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 45 studies in Attention Deficit Disorder with Hyperactivity with a site in Turkey — 5 open to participants now, 7 under way, none of them phase 3. Attention Deficit Disorder with Hyperactivity · Turkey.

Planned enrollment
11th of 17
80 · median 85
Started
2026
with 1 other
Observational
17 of 45
3 open now
Registered
44th of 45
by date
Lead sponsor
4 of 45
Akdeniz University

Among the 45 studies in Attention Deficit Disorder with Hyperactivity with a site in Turkey, this one is the 11th largest by planned enrollment of the 17 observational ones that give a count, is one of 2 that started in 2026, is one of 17 observational ones, and was the 44th registered.

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 295 are open to participants now.

Browse Attention Deficit Disorder with Hyperactivity studies →

Open to participants now

5 of the 45 studies in Attention Deficit Disorder with Hyperactivity with a site in Turkey are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 201 Attention Deficit Disorder with Hyperactivity studies recruiting now, 27 (13%) set no upper age limit and 169 (84%) stop at 75 or younger; 141 take children under 18; 55 take healthy volunteers.

This study: 10 Years to 18 Years · all sexes · healthy volunteers too.

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02

Study 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). 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.

03

Conditions studied

  • Attention-Deficit/Hyperactivity Disorder (ADHD)

Keywords

  • ADHD
  • Peripheral Biomarkers
  • Functional Connectivity
  • Emotional Regulation
  • Executive Functions
  • Resting-State Functional MRI
04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 10-18 years, including ages 10 and 18.
  • Diagnosis of attention-deficit/hyperactivity disorder (ADHD) according to criteria.
  • Clinically normal intellectual capacity (IQ >80).
  • Predominantly right-handed.
  • No acute or chronic inflammatory disease.

Healthy Control Group:

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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).
  • Autism spectrum disorder.
  • Psychotic disorder.
  • Mood disorder.
  • Conduct disorder.
  • Active anxiety disorder or substance use disorder.
  • Presence of an acute or chronic inflammatory disease.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

    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.

    Other: No Intervention

Interventions

  • OtherNo Intervention

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the baseline assessment

Secondary outcomes

  1. 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.

    Time frame: At the baseline assessment

  2. 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.

    Time frame: At the baseline assessment

  3. 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.

    Time frame: At the baseline assessment

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 28, 2026
First posted
Sep 2, 2026
StartActual
Mar 1, 2026
Primary completionEst.
Dec 1, 2026
CompletionEst.
Jan 31, 2027
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07800117
Lead sponsor
Akdeniz University
Responsible party
Sponsor
First posted
Sep 2, 2026
Start date
Mar 1, 2026
Primary completion
Dec 1, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Sep 2, 2026

Study contacts

Hicran Doğru, MD
principal investigator · Akdeniz University
Kadir Tunçer, MD
study director · Akdeniz University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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