[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"methylphenidate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:methylphenidate":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100585686","phase-3-methylphenidate-in-pediatric-brain-tumor-survivors-with-cancer-related-fatigue-100585686",false,"NCT06905587","Methylphenidate in Pediatric Brain Tumor Survivors With Cancer-related Fatigue","Effect of Methylphenidate on Cancer-related Fatigue in Patients Treated for a Brain Tumor During Childhood or Adolescence: Protocol for a Randomized, Double-blind, Placebo-controlled Crossover Trial - the EMBRAIN Trial","EMBRAIN","Inclusion Criteria:\n\n1. Diagnosed and treated for a brain tumor during childhood or adolescence (0-≤18 years).\n2. Treated for a PBT during the previous 10 years, starting from date of diagnosis.\n3. Aged ≥6 years 0 months at the start of the trial.\n4. Off therapy\u002Factive treatment for pediatric brain tumor (PBT) for 12 months at the start of the trial.\n5. No known signs of clinical or radiological tumor progression at last follow-up.\n6. Danish is the sole or primary language (enabling provision of validated assessment tools).\n7. Patient and family have provided consent for inclusion in the trial.\n8. Clinically significant fatigue based on the PedsQL MFS questionnaire at baseline, defined by a score ≥ 1 standard deviation below the normative mean.\n9. History of clinically relevant fatigue after treatment of PBT compared to estimated premorbid ability, as assessed from consultations in the childhood cancer outpatient clinics.\n\nExclusion Criteria:\n\n1. Any known contraindications to methylphenidate as outlined below:\n\n   A) Hypersensitivity to the active substance or any excipients listed in the summary of product characteristics. B) Glaucoma. C) Pheochromocytoma. D) Hyperthyroidism. E) Mania. F) Psychosis. G) Anorexia nervosa. H) Current or previous severe depression. I) Suicidal behavior. J) Poorly controlled type 1 bipolar affective disorder. K) Antisocial or borderline personality disorder. L) Pre-existing cardiovascular disorders, including severe hypertension, heart failure, arterial occlusive disease, angina pectoris, hemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening cardiac arrhythmias and channelopathies. M) Pre-existing cerebrovascular disease, cerebral aneurysm, vascular abnormalities including vasculitis or stroke. N) Treatment with irreversible MAO inhibitors within the last 14 days and reversible MAO inhibitors within the last 24 hours.\n2. History of recent poorly controlled seizures.\n3. Motor tics or Tourette syndrome (including family history of tic disorder).\n4. Known diagnosis of Attention Deficit\u002FHyperactivity Disorder or Autism Spectrum Disorder.\n5. Known diagnosis of Full Scale Intelligence Quotient (FSIQ) of \\\u003C50.\n6. Pregnancy. Participants known to be pregnant or breastfeeding at screening\u002Fregistration will not be enrolled in the trial. All sexually active women of childbearing potential (WOCBP) must have a negative pregnancy test prior to the start of treatment. Acceptableeffective contraceptive must be used for the duration of the trial. No further testing is needed during trial, unless the participant suspects to have become pregnant.\n7. Concerns about family ability to safely store or administer MPH, or to report side effects appropriately\u002Fconcerns about familial substance abuse.\n8. Concurrent use of opiods (ATC N02A) or benzodiazepines (ATC N05BA and N05CF).\n9. Simultaneously enrolled in another clinical trial investigating cancer-related fatigue with a pharmaceutical intervention.","ALL","6 Years","27 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","Cancer-related fatigue is a common and debilitating late effect in pediatric brain tumor survivors. Currently, evidence-based recommendations to ameliorate this condition are lacking.\n\nThe researchers will investigate the ability of methylphenidate to improve fatigue and cognition in pediatric brain tumor survivors suffering from cancer-related fatigue. Methylphenidate is a drug (central nervous stimulant) most commonly used in the treatment of hyperkinetic disorders such as attention-deficit\u002Fhyperactivity disorder (ADHD).\n\nIf methylphenidate shows an effect, the prospects are important for this patient group, since methylphenidate may then be included as part of the treatment of brain tumor-related fatigue.",[28,29,30],"Brain Tumor, Pediatric","Cancer-related Fatigue","Methylphenidate",[32,33,34,35,36,37,38,39,40,41],"methylphenidate","cancer-related fatigue","brain tumor","childhood cancer","pediatric cancer","childhood cancer survivor","late effect","long-term effects secondary to cancer therapy in children","long-term effects of cancer-treatment","pediatric brain tumor","RECRUITING","2026-06-23",{"date":45,"type":46},"2026-06-26","ACTUAL",{"date":48,"type":46},"2025-09-02",{"date":50,"type":22},"2029-12",{"name":52,"class":53},"Odense University Hospital","OTHER",4,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":63,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100602293","phase-4-pharmacokinetics-of-methylphenidate-in-adult-patients-with-attention-deficit-hyperactivity-disorder-100602293","NCT07121621","PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit \u002FHyperactivity Disorder","PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit \u002FHyperactivity Disorder: Comparison Between Patients With and Without OBesity","PHACYLOB","Inclusion Criteria:\n\n* Adults aged 18 and over\n* Diagnosis of ADHD by a psychiatrist, based on DSM-5 criteria (ADHD mixed form, predominantly inattentive or predominantly hyperactive\u002Fimpulsive)\n* Treatment with methylphenidate LP (Ritaline) with a stable dosage for at least two weeks.\n* BMI inclusion criteria: (1) for obese group: BMI ≥ 30 kg\u002Fm2; (2) for non-obese group: BMI \\\u003C 30 kg\u002Fm2.\n* Participant affiliated to a social security scheme\n* Written consent signed by participant\n\nExclusion Criteria:\n\n* Contraindications to methylphenidate treatment\n* Treatment with an oral or nasal decongestant vasoconstrictor; association with a non-selective MAOI antidepressant.\n* Treatment with a proton pump inhibitor within the last 2 weeks.\n* Severe cognitive impairment (clinical evaluation)\n* Severe alcohol use disorder, i.e. at least 6 DSM-5 criteria for substance use disorder (clinical evaluation)\n* Known prior renal impairment\n* Pregnant or breast-feeding women\n* Female patients of childbearing age without at least one acceptable contraceptive method (see definition in Appendix 1)\n* Patients under legal protection\n* Inability of the patient to self-assess the intensity of ADHD symptoms","18 Years",{"count":65,"type":22},30,[67],"PHASE4","PHACYLOB PHArmaCokinetics of methYLphenidate in adult patients with Attention-Deficit Hyperactivity Disorder (ADHD) : comparison between patients with and without OBesity.\n\nIts aim is to determine whether, for a comparable treatment dose, there are differences in the pharmacokinetic of methylphenidate between ADHD patients with obesitý and ADHD patients but without obesitý. More specifically, we will assess whether blood concentrations of methylphenidate (MPH; long acting form) are significantly higher or lower in either group at different times of the day.\n\nTo meet this objective, we are conducting this pharmacokinetic clinical trial with blood sampling and repeated clinical measurements just prior to MPH administration (= at T0) and then, at different times after administration, i.e. at times (T): T 30 minutes, T 1 hour, T2h, T3h, T4h, T6h, T8h after MPH administration. As far as MPH is concerned, this is the usual treatment. However, we may hypothesize that the distribution in the body may differ according to weight: hence the interest of this study",[70,71,30,72],"Attention Deficit Hyperactivity Disorder (ADHD)","Obesity (Body Mass Index &Amp;Amp;gt;30 kg\u002Fm2)","Obesity &Amp; Overweight",[30,70,74,75],"Obesity","Pharmacokinetics","NOT_YET_RECRUITING","2025-08-12",{"date":79,"type":46},"2025-08-13",{"date":81,"type":22},"2025-09-01",{"date":83,"type":22},"2026-09-02",{"name":85,"class":53},"University Hospital, Tours",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":95,"targetDuration":4,"studyType":97,"phases":4,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":86},"100521736","metabolic-mechanisms-of-the-electrophysiological-biomarkers-for-response-to-methylphenidate-treatment-in-children-with-adhd-100521736","NCT06073470","Metabolic Mechanisms of the Electrophysiological Biomarkers for Response to Methylphenidate Treatment in Children With ADHD","Exploration of the Metabolic Mechanisms of the Electrophysiological Biomarkers for Response to Methylphenidate Treatment in Children With Attention-Deficit\u002FHyperactivity Disorder","1. Patients with ADHD\n\n   1. Inclusion Criteria\n\n      * Patients, aged 6 to 18 years, meet the DSM-5 diagnostic criteria for ADHD.\n      * At baseline, patients have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score greater than 4.\n      * Patients have a Full IQ (FIQ) score greater than 80.\n   2. Exclusion Criteria\n\n      * Patients have a major psychiatric disorder, such as autism spectrum disorder, schizophrenia, affective disorders, or substance use disorders.\n      * Patients have a major disorder of central nervous system, such as epilepsy.\n      * Patients have a major systemic disease, such as diabetes mellitus or cardiovascular diseases.\n      * Patients have ever received any medication to treat the clinical symptoms of ADHD.\n2. Neurotypical participants:\n\n   1. Inclusion Criteria\n\n      * aged 6 to 18 years\n      * All of the neurotypical participants have no psychiatric disorder in lifetime according to the diagnostic criteria of DSM-5.\n   2. Exclusion Criteria\n\n      * participants have any disorder of central nervous system or major systemic disease\n      * participants have ever taken any psychotropic drug, or who have FIQ scores less than 80, will be excluded from the present study.",true,{"count":96,"type":22},160,"OBSERVATIONAL","To explore the relationship of treatment-related changes in electrophysiology and those in metabolomics for identification of the underlying metabolic mechanisms for the electrophysiological effects of methylphenidate in children with ADHD.",[30,100],"Metabolomics","2024-03-25",{"date":103,"type":46},"2024-03-26",{"date":105,"type":46},"2024-01-01",{"date":107,"type":22},"2027-12-31",{"name":109,"class":53},"National Taiwan University Hospital"]