NCT07590180

Brief Summary

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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
6mo left

Started May 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
May 2026Jan 2027

Study Start

First participant enrolled

May 1, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 10, 2026

Last Update Submit

May 10, 2026

Conditions

Keywords

Internet addictionChild and adolescent psychiatryNeurogenesisNeurotrophic factorsBDNFGDNFImpulsivityReward/punishment sensitivityInternet gaming disorder

Outcome Measures

Primary Outcomes (2)

  • Comparison of Serum BDNF and GDNF Levels

    Serum concentrations of Brain-Derived Neurotrophic Factor (BDNF) and Glial-Derived Neurotrophic Factor (GDNF) will be measured in picograms per milliliter (pg/mL) to identify biological differences between the Internet Gaming Disorder (IGD) group and healthy controls.

    Baseline (at the time of enrollment)

  • Differences in Impulsivity and Reward/Punishment Sensitivity Scores

    Comparison of psychometric assessment scores between the IGD group and healthy controls to evaluate behavioral differences.

    Baseline (at the time of enrollment)

Secondary Outcomes (1)

  • Correlation Between Neurotrophic Factors and Behavioral Scores in the IGD Group

    Baseline

Study Arms (2)

IGD Patient Group

The patient group consists of children aged 10-14 who meet the DSM-5 diagnostic criteria for Internet Gaming Disorder (IGD). Participants are required to be literate and to have provided written informed consent along with their legal guardians after a comprehensive explanation of the study protocols.

Other: Clinical Evaluation and Biochemical Sampling

Healthy Control Group

The healthy control group consists of volunteer children aged 10-14 who have no current or past history of neuropsychiatric disorders based on comprehensive clinical psychiatric evaluations. Participants are required to be literate and to have provided written informed consent along with their legal guardians, following a detailed explanation of the study's objectives and the assessment scales to be administered.

Other: Clinical Evaluation and Biochemical Sampling

Interventions

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).

Healthy Control GroupIGD Patient Group

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population will consist of children and adolescents who visit the Child and Adolescent Psychiatry outpatient clinics at Bakırköy Prof. Dr. Mazhar Osman Training and Research Hospital for Psychiatry, Neurology, and Neurosurgery between May 2026 and December 2026. The participants will include a patient group meeting the specific inclusion criteria for Internet Gaming Disorder and an age- and gender-matched healthy control group. The control group will be recruited from volunteers attending the psychiatry or pediatric outpatient clinics of the same hospital who meet the control criteria. All participants and their legal guardians will be volunteers who have provided written informed consent after a detailed explanation of the study.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bakırköy Prof. Dr. Mazhar Osman Training and Research Hospital for Psychiatry, Neurology, and Neurosurgery

Istanbul, Bakirkoy, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral venous blood samples will be collected between 09:00 and 12:00 following a 10-12 hour fasting period. Samples will be drawn into gold-top serum separator tubes (SST) with clot activators. Serum separation will be achieved via centrifugation within 2-3 hours of collection. The resulting serum aliquots will be stored at -80°C until biochemical analysis of BDNF and GDNF levels is performed.

MeSH Terms

Conditions

Internet Addiction DisorderImpulsive Behavior

Condition Hierarchy (Ancestors)

Technology AddictionBehavior, AddictiveCompulsive BehaviorBehavior

Central Study Contacts

Kerim Kızıltan, Medical Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

May 10, 2026

First Posted

May 15, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

The participants' age, scores of the clinical scales examined in the study, and levels of serum samples will be shared. In other words, the necessary data relevant to the purpose of the study will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations