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Recruiting NCT07590180

Neurotrophic Factors, Impulsivity, and Reward Sensitivity in Children With Internet Gaming Disorder

Observational Internet Gaming Disorder Internet Addiction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Clinical Evaluation and Biochemical Sampling.
Who it may be relevant to
Registry conditions: Internet Gaming Disorder, Internet Addiction. Basic parameters: 10 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigation of the Relationship Between Serum BDNF and GDNF Levels and Impulsivity, Reward/Punishment Sensitivity in Children Diagnosed With Internet Gaming Disorder

Overview

Research and knowledge regarding the neurobiology of behavioral addictions and Internet Gaming Disorder (IGD) remain limited compared to substance and alcohol use disorders. However, IGD is increasingly causing significant functional impairment, particularly in the child and adolescent population. The primary objective of this study is to measure the serum levels of Brain-Derived Neurotrophic Factor (BDNF) and Glial-Derived Neurotrophic Factor (GDNF)-both known for their roles in neurogenesis and neuroprotective effects-in a patient group aged 10-14 and a healthy control group. Additionally, this study aims to investigate the relationship between these neurotrophic factor levels and disease severity, as well as various behavioral and emotional parameters measured through psychometric assessments, to identify differences between the patient and healthy populations. Researchers will compare IGD patient group with healthy control group, both aged 10-14. Participants and their parents will be asked to fill self-report measures and serum samples of participants will be collected for BDNF and GDNF level measurements. The main questions of the study are: * Is there a difference in serum BDNF and GDNF levels between IGD patient group and healthy controls? * Is there a relation between serum BDNF and GDNF levels and IGD severity? * Is there a difference in impulsivity, reward/punishment sensitivity between IGD patient group and healthy controls * Is there a relation between serum BDNF and GDNF levels and impulsivity, reward/punishment sensitivity scores in IGD patient group?

Detailed description

Between May 2026 and December 2026, informed consent and assent will be obtained from participants and their parents/legal guardians after a comprehensive explanation of the study objectives, psychometric scales, and psychiatric evaluation protocols. This research is designed as a cross-sectional case-control study. The patient group will include children and adolescents diagnosed with Internet Gaming Disorder (IGD) according to DSM-5 criteria. The control group will consist of age- and gender-matched individuals attending psychiatry or pediatric outpatient clinics or volunteers who meet the control inclusion criteria and have provided written informed consent.

The primary investigator will conduct clinical psychiatric interviews with all participants in both the case and control groups to verify eligibility and diagnostic status. The following psychometric instruments will be administered:

For children (Case and Control groups): Internet Gaming Disorder Scale-Short Form (IGDS9-SF), Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ), UPPS-P Impulsive Behavior Scale for Children (C-UPPS-P), Screen for Child Anxiety Related Emotional Disorders (SCARED) - Child Form, and Children's Depression Inventory (CDI).

For parents (Case and Control groups): SCARED - Parent Form, and the Turgay DSM-IV-based Screening and Assessment Scale for Disruptive Behavior Disorders (Turgay ADHD Scale).

Joint Assessments: The Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL) and a sociodemographic data form will be administered to both the children and their parents by the researcher.

For biochemical analysis, peripheral venous blood samples will be collected from all participants following a 10-12 hour fasting period between 09:00 and 12:00. Samples will be drawn into gold-top (serum separator) tubes and transported within 2-3 hours to the Brain and Neurodegenerative Diseases Research Laboratory at Istanbul University-Cerrahpaşa, Institute of Neurological Sciences, Department of Neuroscience. Blood tubes will be centrifuged at 5000 rpm for 10 minutes. The separated serum will be aliquoted into 1.5 ml microcentrifuge tubes and stored at -80°C until the final analysis. Once the sample collection phase is complete, serum BDNF and GDNF levels will be determined using Human BDNF (ELH-BDNF-1, RayBiotech) and Human GDNF (ELH-GDNF-1, RayBiotech) ELISA kits. ELISA assays will be conducted strictly following the manufacturers' protocols at the aforementioned laboratory.

Interventions

  • Other Clinical Evaluation and Biochemical Sampling
    Participants and their parents will undergo a cross-sectional clinical psychiatric interview conducted by a child and adolescent psychiatrist. Following the interview, both participants and their parents will be required to complete a battery of standardized self-report and parent-report psychometric scales. At the conclusion of the clinical assessment, a peripheral venous blood sample will be collected from each participant for serum biochemical analysis of neurotrophic factors (BDNF and GDNF).

Primary outcome measures

  • Comparison of Serum BDNF and GDNF Levels [Time frame: Baseline (at the time of enrollment)]
  • Differences in Impulsivity and Reward/Punishment Sensitivity Scores [Time frame: Baseline (at the time of enrollment)]
Secondary outcome measures (1)
  • Correlation Between Neurotrophic Factors and Behavioral Scores in the IGD Group [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

For IGD Patient Group:

Age: Being between 10 and 14 years of age. Literacy: Ability to read and write fluently. Informed Consent: Voluntary participation with written informed consent obtained from both the participants and their parents/legal guardians after a comprehensive briefing on the study procedures and scales.

Diagnostic Criteria: Meeting the DSM-5 diagnostic criteria for Internet Gaming Disorder (IGD) and scoring above the clinical cutoff on the Internet Gaming Disorder Scale-Short Form (IGDS9-SF).

For Healthy Control Group:

Age: Children between 10 and 14 years of age. Literacy: Ability to read and write fluently. Clinical Status: No history or current diagnosis of any neuropsychiatric disorder, confirmed through clinical psychiatric assessment.

Informed Consent: Voluntary participation with written informed consent obtained from both the participants and their parents/legal guardians after a comprehensive briefing on the study procedures and scales.

Exclusion criteria

Comorbid Psychiatric Disorders: Meeting the DSM-5 diagnostic criteria for Autism Spectrum Disorder, Schizophrenia, Bipolar I Disorder, or Bipolar II Disorder.

Cognitive and Neurological Impairment: Having a moderate to severe intellectual disability and/or a neurological disease in either the child or the caregiver that would impede the ability to understand instructions or provide reliable responses during the interview.

Lack of Informed Consent: Refusal to participate voluntarily or failure to sign the informed consent/assent form by the children or their parents/legal guardians after receiving a detailed explanation of the study's purpose and the assessment scales to be administered.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Bakırköy Prof. Dr. Mazhar Osman Training and Research Hospital for Psychiatry, Neurology, — Istanbul

Identifiers

NCT: NCT07590180 · 2026/148

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗