BDNF, Inflammatory and Oxidative Levels in Treatment-Naïve ADHD Children Treated with Methylphenidate: an Open Cohort Protocol

The attention-deficit hyperactivity disorder (ADHD) has a complex etiology, involving the interaction between biological, genetic, and environmental factors. The ADHD pathophysiology remains unknown even though there are hypotheses that inflammatory, hormonal, oxidative and neurotrophic factors are associated. This clinical trial aims to evaluate the contribution of brain derived neurotrophic factor (BDNF), inflammatory and oxidative levels before and after 12 and 24 weeks of methylphenidate use.Methods Patients will be screened upon their entry into Child and Adolescent Psychiatry Teaching Outpatient Clinic of the Medical Course at the Federal University of Viçosa in Minas Gerais, Brazil. One hundred and fifty ADHD treatment-naïve children of both sexes, between 6–14 years old, will be invited to participate, after the ADHD diagnosis by an experienced psychiatrist and the child fulfilling the inclusion criteria. Children and their caregivers will answer questionnaires regarding mental health and the children will undergo neuropsychological tests, physical, nutritional and activity assessment, in addition to blood sampling at baseline, 12 and 24 weeks of methylphenidate use respectively.Discussion This clinical trial intends to verify how the pharmacological treatment changes the plasma BDNF, inflammatory and oxidative levels in treatment-naïve Brazilian children diagnosed for ADHD.Trial Registration Submitted for registration on Brazilian Registry of Clinical Trials (ReBEC). Trial identifier: 13612Registry name: Níveis de neurotrofina, perfil inflamatório e oxidativo em crianças com TDAH tratadas com metilfenidato.### Competing Interest StatementThe authors have declared no competing interest.### Clinical TrialThe Universal Trial Number (UTN) is U1111-1285-2908. Submitted for registration on Brazilian Registry of Clinical Trials (ReBEC). Trial identifier: 13612. Registry name: Neurotrophin level, inflammatory and oxidative profile in ADHD children treated with methylphenidate.### Funding StatementDMM - National Council for Scientific and Technological Development (CNPQ). SAC - Research Support Foundation of the State of Minas Gerais (FAPEMIG - APQ-01023/18)### Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.Not ApplicableThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:Approved by the Research Ethics Committee of the Federal University of Minas Gerais. Number: 4.364.744. CAAE: 82870117.0.3001.5149. Written, informed consent to participate will be obtained from all parents, as well as informed assent from the children.I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.Not ApplicableI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).Not ApplicableI have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.Not ApplicableNo datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.