Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2025-12-30 @ 3:43 PM
Study NCT ID:
NCT07041333
Status:
RECRUITING
Last Update Posted:
2025-09-23
First Post:
2025-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect Of Methylphenıdate Treatment On Neuroınflammatıon Levels In Chıldren Wıth Attentıon Defıcıt Hyperactıvıty Dısorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-06-16', 'size': 208145, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-06-19T03:38', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-20', 'studyFirstSubmitDate': '2025-06-19', 'studyFirstSubmitQcDate': '2025-06-19', 'lastUpdatePostDateStruct': {'date': '2025-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in IL-6 marker level', 'timeFrame': 'Immediately before starting the treatment and up to the 3rd month of treatment.'}, {'measure': 'Change in S100B marker level', 'timeFrame': 'Immediately before starting the treatment and up to the 3rd month of treatment.'}, {'measure': 'Change in the level of claudin-5 marker', 'timeFrame': 'Immediately before starting the treatment and up to the 3rd month of treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['methylphenidate', 'Attention Deficit Hyperactivity Disorder', 'ADHD', 'neuroinflammation'], 'conditions': ['Attention Deficit Disorder With Hyperactivity (ADHD)']}, 'referencesModule': {'references': [{'pmid': '33114154', 'type': 'RESULT', 'citation': 'Corona JC. Role of Oxidative Stress and Neuroinflammation in Attention-Deficit/Hyperactivity Disorder. Antioxidants (Basel). 2020 Oct 23;9(11):1039. doi: 10.3390/antiox9111039.'}, {'pmid': '27426904', 'type': 'RESULT', 'citation': 'Leung AK, Hon KL. Attention-Deficit/Hyperactivity Disorder. Adv Pediatr. 2016 Aug;63(1):255-80. doi: 10.1016/j.yapd.2016.04.017. No abstract available.'}, {'pmid': '26207130', 'type': 'RESULT', 'citation': 'Kul M, Unal F, Kandemir H, Sarkarati B, Kilinc K, Kandemir SB. Evaluation of Oxidative Metabolism in Child and Adolescent Patients with Attention Deficit Hyperactivity Disorder. Psychiatry Investig. 2015 Jul;12(3):361-6. doi: 10.4306/pi.2015.12.3.361. Epub 2015 Jul 6.'}, {'pmid': '36879528', 'type': 'RESULT', 'citation': 'Koc S, Guler EM, Derin S, Gultekin F, Aktas S. Oxidative and Inflammatory Parameters in Children and Adolescents With ADHD. J Atten Disord. 2023 Jun;27(8):880-886. doi: 10.1177/10870547231159907. Epub 2023 Mar 6.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to investigate the effect of treatment of ADHD with methylphenidate on neuroinflammation by examining the levels of Interleukin-6 (IL-6), S100B, Claudin-5 in serum samples of patients who were diagnosed with attention deficit hyperactivity disorder (ADHD) and started or planned to start methylphenidate for treatment as per routine, at month 0 before the initiation of methylphenidate treatment and at month 3 after the initiation of treatment.', 'detailedDescription': 'After informed consent, a structured clinical interview for DSM-5-TR will be conducted using the "Emotional Disorders and Schizophrenia Form for School-Age Children - Current and Lifetime Form DSM-5 - Turkish Adaptation (ÇDŞG-ŞY-DSM-5-T)". The "Sociodemographic and Clinical Data Form" created by the researchers will be completed to obtain sociodemographic and clinical data for the participants. The "Conners Parent Rating Scale-Revised Short Form" and "Conners Teacher Rating Scale-Revised Short Form" will be administered to the group diagnosed with ADHD to determine the severity of the disease, symptoms, and predominant subtypes. After the diagnosis is made and evaluated according to the exclusion criteria, peripheral venous blood will be collected in yellow-capped tubes between 9 and 12 a.m. after a 10-12 hour fast, prior to the routine planned methylphenidate treatment. After being left at room temperature for 10-20 minutes, the blood will be centrifuged at 3000 RPM for 20 minutes, and the serum portion will be collected into Eppendorf tubes and stored at -80 degrees until the samples are analyzed. Three months after starting treatment, blood will be collected and stored in the same manner. After all samples have been collected, the serum samples will be analyzed in a single batch for Interleukin-6 (IL-6), S100B, and Claudin-5 levels using human ELISA kit protocols at the Medical Biochemistry Laboratory of Bakırköy Dr. Sadi Konuk Training and Research Hospital by biochemistry specialist Dr. Hacer Eroğlu İçli. Three months after the start of treatment, the Conners Parent Rating Scale - Revised Short Form and the Conners Teacher Rating Scale - Revised Short Form will be administered again.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who applied to Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital, diagnosed with Attention Deficit Hyperactivity Disorder, deemed suitable for methylphenidate treatment, and for whom methylphenidate treatment is planned, have been referred to us.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. According to DSM-5 TR, the participant must have a diagnosis of "Attention Deficit Hyperactivity Disorder" and have started/be planning to start routine methylphenidate treatment.\n2. The participant must be between 6 and 11 years of age.\n3. The participant must agree to participate in the study after being informed about it.\n\nExclusion Criteria:\n\n1. The presence of a psychiatric disorder diagnosis other than Attention Deficit Hyperactivity Disorder\n2. Having a diagnosis of Attention Deficit Hyperactivity Disorder but not planning to start methylphenidate\n3. Being under 6 years of age or over 11 years of age\n4. Having organic brain damage, mental retardation, autism spectrum disorder, neurological disease, or a physical illness that affects neurocognitive functions\n5. History of alcohol and/or psychoactive substance use\n6. Presence of ongoing active infection, allergic disease, and chronic illness\n7. Previous use of psychiatric medication.\n8. Presence of chronic illness\n9. Regular use of medication'}, 'identificationModule': {'nctId': 'NCT07041333', 'briefTitle': 'The Effect Of Methylphenıdate Treatment On Neuroınflammatıon Levels In Chıldren Wıth Attentıon Defıcıt Hyperactıvıty Dısorder', 'organization': {'class': 'OTHER', 'fullName': 'Saglik Bilimleri Universitesi'}, 'officialTitle': 'The Effect Of Methylphenıdate Treatment On Neuroınflammatıon Levels In Chıldren Wıth Attentıon Defıcıt Hyperactıvıty Dısorder', 'orgStudyIdInfo': {'id': '2025-04-11'}, 'secondaryIdInfos': [{'id': 'Etik komite', 'type': 'OTHER', 'domain': 'BAKIRKÖY DR. SADİ KONUK EĞİTİM VE ARAŞTIRMA HASTANESİ Klinik Araştırma Etik Kurulu'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient group', 'description': 'Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34147', 'city': 'Istanbul', 'state': 'Bakırkoy', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Mehmet TEKDEN, Lecturer', 'role': 'CONTACT', 'email': 'mtekden07@gmail.com', 'phone': '+902124091515'}], 'facility': 'Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospita', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Enes F ALTUNKILIÇ, Medicine Doctor', 'role': 'CONTACT', 'email': 'enesfarukaltunkilic@gmail.com', 'phone': '+905077362191'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enes Faruk ALTUNKILIÇ', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Child and adolescent psychiatrist', 'investigatorFullName': 'Enes Faruk ALTUNKILIÇ', 'investigatorAffiliation': 'Saglik Bilimleri Universitesi'}}}}