Investigation of the Association of Multimodal Neuroimaging and Peripheral Biomarkers With Executive Functions and Emotional Regulation in Adolescents With Attention-Deficit/Hyperactivity Disorder

NCT07800117 | Active Not Recruiting

• 1 other identifier: TTU-2026-7133
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Keywords

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

Outcome Measures

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.

  At the baseline assessment

Secondary Outcomes (3)

• Serum BDNF, Cortisol, IL-1α, IL-6, TNF-α, and IFN-γ Levels

  At the baseline assessment

• Executive Functioning Measured by the Behavior Rating Inventory of Executive Function (BRIEF)

  At the baseline assessment

• Emotion Regulation Difficulties Measured by the Difficulties in Emotion Regulation Scale

  At the baseline assessment

Study Arms (2)

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

No Intervention OTHER

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.

ADHD; Healthy Control Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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:
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Faculty of Medicine Hospital

Antalya, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples will be collected from participants after a 12-hour fasting period. Serum will be obtained by centrifugation and stored at -80°C until analysis. 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 using enzyme-linked immunosorbent assay (ELISA).

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Emotional Regulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

• Hicran Doğru, MD

  Akdeniz University

  PRINCIPAL INVESTIGATOR

• Kadir Tunçer, MD

  Akdeniz University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Locations

TU (1)