[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610333":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":33,"responsibleParty":51,"collaborators":31,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":31,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":31,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":35,"whyStopped":31,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"St. Jude Children's Research Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Methylphenidate Treatment Group","EXPERIMENTAL","All participants in this single-arm pilot study will receive extended-release methylphenidate for 4 weeks. The intervention is designed to evaluate feasibility, acceptability, adherence, and safety of stimulant treatment in children and adolescents with sickle cell disease (SCD) and executive functioning deficits.",[13],"Drug: Extended-Release Methylphenidate",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Extended-Release Methylphenidate","Participants will receive a weight-based dose of extended-release methylphenidate (0.6 mg\u002Fkg\u002Fday), rounded to either 10 mg or 20 mg, taken orally once daily for 4 weeks.",[9],[21],"MPH",[23],{"name":24,"affiliation":5,"role":25},"Andrew W. Heitzer, PhD","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Andrew Heitzer, PhD","CONTACT","888-226-4343",null,"referralinfo@stjude.org",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Memphis","Tennessee","38105","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-90.04898,35.14953,{"lat":45,"lon":44},[48,49],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":50,"role":25,"phone":31,"phoneExt":31,"email":31},"Andrew K Heitzer, PhD",{"type":52,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100610333","phase-1-methylphenidate-to-address-attention-and-executive-deficits-among-children-with-sickle-cell-disease-100610333",false,"NCT07226219","Methylphenidate to Address Attention and Executive Deficits Among Children With Sickle Cell Disease","Pilot Trial of Stimulant Treatment to Address Attention and Executive Deficits Among Children With Sickle Cell Disease","Inclusion Criteria:\n\n* Diagnosed with SCD of any genotype\n* Enrolled on the institutional protocol: Sickle Cell Clinical Research Intervention Program (SCCRIP)\n* Between the ages of 8.0 and 17.9 years\n\n  \\*Included if performance measure, rating scale or diagnostic criteria met (within the past 2 years):\n* \\*Score at or below the 16th percentile on any 2 out of 4 performance measures:\n\n  * NIH Toolbox Flanker\n  * NIH Toolbox List Sorting\n  * NIH Toolbox Dimensional Change Card Sort Test (DCST)\n  * Wechsler Intelligence Scale for Children (WISC) -5\u002F Wechsler Adult Intelligence Scale (WAIS)-4 Digit Span Forward (DSF)\n* \\*Score at or above the 84th percentile on any 1 out of 2 parent rating scales:\n\n  * BRIEF-2 Global Executive\n  * BASC-3 Attention\n* \\*Have a documented diagnosis of attention deficit \u002F hyperactivity disorder (any subtype)\n* English as the primary language\n* Research participant and one parent willing to participate and provide consent\u002Fassent according to institutional guidelines\n* Negative pregnancy test\n\nExclusion Criteria:\n\n* Primary language other than English\n* Score below the 2nd percentile on the Wechsler Abbreviated Scale of Intelligence (WASI)-2 intelligence quotient (IQ) test\n* Uncontrolled seizures (seizure within the past 6 months)\n* Cardiomyopathy or known congenital structural cardiac defects\n* Stenotic valvular disease, left coronary artery stenosis, or history of myocarditis or pericarditis\n* History of heart arrhythmia including ventricular tachycardia, ventricular fibrillation, supraventricular tachycardia, QT prolongation or concomitant use of medications associated with QT prolongation\n* Two or more prior episodes of priapism\n* Blood pressure \\>95th percentile at the three most recent visits consecutively (i.e., \\>95th percentile reading at all three of the most recent hospital visits to St. Jude).\n\n  * If blood pressure is \\> 95th %ile compared to age-norms on the day of the baseline visit, a repeat blood-pressure reading will be performed both electronically and manually to confirm findings.\n* Stimulant medication within the past two weeks\n* Severe sensory loss\n* Previous adverse reaction to methylphenidate\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.\n* Currently prescribed another investigational medication.\n* Currently prescribed any of the following:\n\n  * Phenobarbital (anticonvulsant)\n  * Phenytoin (anticonvulsant)\n  * Primidone (anticonvulsant)\n  * Warfarin (anticoagulant)\n  * Antipsychotic medications\n  * Selective Serotonin Reuptake Inhibitor (SSRI) medications\n  * Tricyclic antidepressant (TCA) medications\n  * Vasopressor medications","ALL","8 Years","17 Years",{"count":64,"type":65},72,"ESTIMATED","INTERVENTIONAL",[68],"PHASE1","The purpose of this study is to determine if patients with sickle cell disease (SCD) can consistently take a drug called Methylphenidate (MPH) daily, once a day for 4 weeks to help with any thinking, attention or schoolwork problems and if they have any side effects.\n\nThe study will assess any thinking or attention problems participants may have both before taking this drug and after. Additionally, the study will assess the decision-making process of the caregiver that may influence using this drug or not.\n\nPrimary Objective:\n\n• Assess the feasibility, acceptability, and adherence to MPH treatment in children with SCD and EF deficits.\n\nSecondary Objective:\n\n• Evaluate neurobehavioral and safety outcomes following MPH treatment.\n\nExploratory Objective:\n\n• Evaluate decision-making and determinants influencing methylphenidate utilization among parents.",[71,72,73,74],"Sickle Cell Disease","Executive Dysfunction","Cognitive Impairment","Attention Deficit\u002FHyperactivity Disorder (ADHD)",[76,77],"SCD","ADHD","2026-04-22",{"date":80,"type":81},"2026-04-23","ACTUAL",{"date":83,"type":81},"2025-11-25",{"date":85,"type":65},"2028-08",{"name":5,"class":6},1]