[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"attention-deficit-disorder-with-hyperactivity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:attention-deficit-disorder-with-hyperactivity":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,50,73,104,126,188,223,259,281],{"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":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100626932","accelerated-and-extended-itbs-targeting-inhibitory-control-in-veterans-with-adhd-100626932",false,"NCT07442058","Accelerated and Extended-iTBS Targeting Inhibitory Control in Veterans With ADHD","ACHIEVE: Accelerated and Extended-rTMS to Heighten Inhibitory Control Engagement in Veterans","ACHIEVE","Inclusion Criteria:\n\n* Diagnosis of ADHD predominantly hyperactive-impulsive or combined, as outlined in the DSM-5-TR criteria\n* Maintenance of clinical symptoms despite receiving stable treatment for a minimum of 6 weeks before the study procedures\n* Capability to comprehend and provide informed consent\n* For safety reasons, participants must meet established screening criteria to ensure safety during Magnetic Resonance Imaging (MRI) scans\n\n  * This precaution is taken due to the novel application of iTBS in this specific population, as MRI involves exposure to magnetic fields similar in intensity to those emitted from the stimulation coil\n* As such, participants must not have the following, unless the devices are MRI-safe:\n\n  * cardiac pacemaker\n  * implanted devices (such as deep brain stimulators)\n  * metal in the brain\n  * cervical spinal cord, or upper thoracic spinal cord level\n* In addition, eligible Veterans must also be able and willing to comply with all study procedures and visits\n* Throughout the study, pharmacologic and psychotherapeutic regimens will tentatively remain unchanged\n\nExclusion Criteria:\n\n* Primary psychotic disorders, bipolar I disorder, ongoing severe substance use disorders, or active suicidality\n* Non-MRI safe cardiac pacemakers, implanted devices, or metallic implants at the upper thoracic spine level or higher\n* Any of the Transcranial Magnetic Stimulation (TMS) specific exclusion criteria, including:\n\n  * pregnancy\n  * lactation\n  * planning pregnancy during period of study\n  * history of moderate or severe traumatic brain injury\n  * active unstable medical conditions\n  * CNS tumors\n  * seizures\n  * cerebrovascular disease\n  * other severe neurological disorders\n* Additional exclusion criteria include the presence of any other condition or circumstance that, as determined by the investigator team, has the potential to prevent study completion or introduce confounding effects in outcome assessments","ALL","18 Years","65 Years",{"count":21,"type":22},35,"ESTIMATED","INTERVENTIONAL",[25],"NA","Impaired inhibitory response manifests clinically as increased impulsivity, which leads to poorer affective, cognitive, social, and occupational functioning. Neuropsychiatric disorders prevalent among Veterans, such as Attention Deficit\u002FHyperactivity Disorder (ADHD), are associated with poor inhibitory control. The mainstay of clinical treatment for ADHD is psychostimulants, yet these medications have significant risks, including dependence and numerous side effects. Thus, novel and non-pharmacological therapeutic strategies are needed. Intermittent Theta Burst Stimulation, a newer form of transcranial magnetic stimulation, has emerged as a promising tool for modulating inhibitory neuronal circuits. This research proposal will investigate the feasibility and acceptability of iTBS on inhibitory control and impulsivity through a randomized controlled trial to inform clinical observations. The long-term goal is to improve impulsivity, social and occupational functioning, and enhance the quality of life for Veterans.",[28],"Attention Deficit Disorder With Hyperactivity",[30,31,32,33,34,35,36],"Attention Deficit Disorder with Hyperactivity","Intermittent Theta-Burst Stimulation","Inhibitory Control","Impulsivity","ADHD","TMS","Transcranial Magnetic Stimulation","NOT_YET_RECRUITING","2026-02-23",{"date":40,"type":41},"2026-03-02","ACTUAL",{"date":43,"type":22},"2026-07-01",{"date":45,"type":22},"2028-07-01",{"name":47,"class":48},"VA Office of Research and Development","FED",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":49},"100466476","home-based-transcranial-direct-current-stimulation-tdcs-for-treatment-of-attention-deficithyperactivity-disorder-adhd-100466476","NCT05354232","Home-based Transcranial Direct Current Stimulation (tDCS) for Treatment of Attention-deficit\u002FHyperactivity Disorder (ADHD)","Inclusion Criteria:\n\n1. Male and female outpatients 18-65 years of age\n2. A diagnosis of ADD\u002FADHD or meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.\n\nExclusion Criteria:\n\n1. Contraindication to tDCS: history or epilepsy, metallic implants in the head and neck, brain stimulators, vagus nerve stimulators, VP shunt, pacemakers, pregnancy.\n2. Active substance dependence (except for tobacco).\n3. Pregnant or nursing females.\n4. Inability to participate in testing procedures.\n5. Premorbid neurological conditions (including neurovascular and neurodegenerative diseases such as traumatic brain injury, stroke, Parkinson's, AD and other dementias) and severe psychiatric disorders (bipolar disorder, schizophrenia).",{"count":57,"type":22},60,[25],"The investigators are investigating whether home-based tDCS over the course of four weeks can improve ADHD symptom severity and improve dysexecutive functioning (cognitive control). Further, the investigators are investigating whether there is a dose-dependent response to tDCS.",[61,28],"Attention Deficit Disorder","RECRUITING","2025-12-05",{"date":65,"type":41},"2025-12-12",{"date":67,"type":41},"2022-07-01",{"date":69,"type":22},"2026-05",{"name":71,"class":72},"Massachusetts General Hospital","OTHER",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":34,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100544502","neurofeedback-based-digital-therapeutics-for-the-diagnosis-and-treatment-of-adhd-in-children-100544502","NCT06369714","Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children.","Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children.","Inclusion Criteria:\n\n* Meet the diagnostic criteria established by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for ADHD.\n* Digital Cancellation Test total score\\\u003C50 points.\n* Raven's Standard Progressive Matrices score≥85.\n* 6 years ≤ Age\\\u003C12 years.\n* No interventions for ADHD received within 4 weeks.\n* No color blindness.\n\nExclusion Criteria:\n\n* Patients with organic mental disorders, schizophrenia, bipolar disorder, depressive disorders, and other psychiatric conditions.\n* Patients with comorbid autism spectrum disorder, Tourette's syndrome, and other neurodevelopmental disorders.\n* Patients with comorbid conduct disorders.\n* Patients with severe traumatic brain injury or neurological disorders.\n* Patients with a history of severe somatic diseases.\n* Patients with a history of substance or drug dependency.","6 Years","12 Years",{"count":83,"type":22},210,[25],"A multi-center, randomized controlled trial is being conducted to investigate the efficacy of a novel digital therapeutics (DTx) program that utilizes a cross-training approach between neurofeedback training and executive function training for pediatric patients (aged 6-12) diagnosed with ADHD. This gamified interactive program is designed to improve attention deficits and executive function impairments in pediatric patients with ADHD. It is delivered through an engaging iPad game in a home-based treatment format. Patients will be randomly assigned to one of three groups: medication alone, digital therapeutics alone, or a combination of both interventions. Subjects will undergo 30 treatment sessions over the 8-week period, with each session lasting 30 minutes. Investigators will reassess symptoms of ADHD, executive functions, and objective measures of attention at the end of the treatment. Additionally, questionnaires will be distributed to parents to gather their insights and feedback on the treatment approach. This innovative digital therapeutics approach is expected to improve ADHD symptoms individually and enhance therapeutic outcomes when used alongside conventional drug treatment regimens.",[28,87],"Executive Function Disorder",[89,90,91,92,93],"Digital Therapeutics","Neurofeedback","Attention Deficit Disorders with Hyperactivity","Children","Executive function disorder","2025-06-08",{"date":96,"type":41},"2025-06-10",{"date":98,"type":41},"2023-02-24",{"date":100,"type":22},"2025-12-31",{"name":102,"class":72},"Lei Lei, MD",2,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":18,"enrollmentInfo":112,"targetDuration":4,"studyType":23,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":124,"locationsCount":49},"100590954","tes-modalities-for-the-treatment-of-adhd-100590954","NCT06974136","tES Modalities for the Treatment of ADHD","Transcranial Electrical Stimulation Modalities for the Treatment of Clinical Symptoms and Cognitive Deficits in Attention-deficit Hyperactivity Disorder Disorder","Inclusion Criteria:\n\n* Diagnosis of ADHD by a licensed psychiatrist and a behavioral checklist\n* being 7-18 years old\n* providing written informed consent signed by parents\n\nExclusion Criteria:\n\n* comorbidity with other neurodevelopmental disorders\n* Comorbidity with other neurological disorders\n* previous history of neurosurgery\n* Presence of any ferromagnetic metal in the head\n* implanted medical devices in the head or neck region\n* history of non-controlled epilepsy with seizures in the last year","7 Years",{"count":113,"type":22},45,[25],"This project investigates the efficacy of transcranial electrical stimulation (tES) modalities, specifically transcranial direct current stimulation (tDCS) and transcranial alternating current stimulation (tACS), for treating Attention-Deficit\u002FHyperactivity Disorder (ADHD) in children and adolescents.",[28,117],"Neurodevelopmental Disorders","2025-05-08",{"date":120,"type":41},"2025-05-15",{"date":122,"type":41},"2025-03-30",{"date":43,"type":22},{"name":125,"class":72},"The National Brain Mapping Laboratory (NBML)",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":17,"minAge":111,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":23,"phases":137,"briefSummary":138,"conditions":139,"keywords":153,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":179,"lastUpdatePostDateStruct":180,"startDateStruct":182,"completionDateStruct":184,"leadSponsor":186,"locationsCount":4},"100577382","the-primary-objective-of-this-study-is-to-determine-whether-positively-framed-information-pfi-on-side-effects-compared-to-negatively-framed-and-extensive-information-nfi-can-reduce-the-number-and-severity-of-reported-adverse-events-caused-by-adhd-medication-in-children-aged-7-to-17-years-100577382","NCT06797570","The Primary Objective of This Study is to Determine Whether Positively Framed Information (PFI) on Side Effects, Compared to Negatively Framed and Extensive Information (NFI) Can Reduce the Number and Severity of Reported Adverse Events Caused by ADHD Medication in Children Aged 7 to 17 Years.","Nocebo Effecten Verminderen in Kinderen Met ADHD: the NOVA Study","NOVA","Inclusion Criteria:\n\n* Children aged 7 to 17 years\n* Recently diagnosed with ADHD or ADD by a psychologist\n* Desire to start ADHD\u002FADD medication expressed by both the child and the parents\n\nExclusion Criteria:\n\n* Previous use of stimulants\n* 1st or 2nd degree family member using stimulants for ADHD\u002FADD within the last two years","17 Years",{"count":136,"type":22},130,[25],"The goal of this randomized controlled care evaluation is to determine whether positively framed and concise information (PFI), compared to negatively framed and extensive information (NFI) about adverse events can reduce the number and severity of reported adverse events caused by ADHD medication in children aged 7 to 17 years. The main questions it aims to answer are:\n\n1. Does PFI reduce the percentage of children suffering from decreased appetite in the first 4 weeks after starting medication compared to NFI?\n2. Does PFI reduce the total number of adverse events compared to NFI?\n3. Does PFI lower the total score on the Pittsburgh Side Effects Rating Scale (PSRS) compared to NFI?\n4. Does PFI lead to higher parental satisfaction with the explanation of adverse events compared to NFI?\n5. Does PFI reduce the number of patients who discontinue medication due to adverse events compared to NFI?\n6. Does PFI decrease the number of patients needing melatonin for sleeping problems due to the use of methylphenidate compared to NFI?\n7. What is the relationship between baseline factors such as age, ADHD or ADD diagnosis, and gender on the number of adverse events?\n\nResearchers will compare children who receive positively framed, concise information (PFI) to those who receive negatively framed, detailed information (NFI) to determine if the framing of information affects the prevalence and severity of reported side effects, medication adherence, and parental satisfaction.\n\nParticipants in this study will:\n\n* Be randomly assigned to receive either PFI or NFI about the side effects of methylphenidate.\n* Start taking methylphenidate according to standard care protocols.\n* Complete a Pittsburgh Side Effects Rating Scale (PSRS) questionnaire 4 weeks after starting medication to report any adverse events and their severity.\n* Parents will provide feedback on satisfaction with the explanation of side effects using a short questionnaire.\n\nThis trial aims to inform best practices for communicating potential side effects to improve medication adherence and the overall treatment experience for children with ADHD and their families.",[61,140,30,34,141,142,143,144,145,146,147,148,149,150,151,152],"Attention Deficit Disorder (ADD)","ADD","ADHD-not Other Specified","ADHD or ADHD Traits","ADHD Predominantly Hyperactivity Type","ADHD Predominantly Inattentive Type","ADHD with Sleep Onset Insomnia","ADHD, ADD","ADHD, Predominantly Hyperactive - Impulsive","ADHD, Predominantly Inattentive Type","Hyperactivity","Hyperactivity Disorder","Inattention",[154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178],"attention deficit hyperactivity disorder","attention deficit disorder","hyperactivity","inattention","adverse drug reaction","adverse events","side effects","nocebo effect","medication side effects","patient education","communication methods","communication strategies","pediatric care","parental satisfaction","pharmacological treatment","treatment","medication adherence","medication","child health","side effect management","treatment compliance","pediatric pharmacology","positive framing","negative framing","side effect reporting","2025-01-22",{"date":181,"type":41},"2025-01-28",{"date":183,"type":22},"2025-01-25",{"date":185,"type":22},"2027-01-06",{"name":187,"class":72},"St. Antonius Hospital",{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":196,"sex":17,"minAge":197,"maxAge":198,"enrollmentInfo":199,"targetDuration":201,"studyType":202,"phases":4,"briefSummary":203,"conditions":204,"keywords":209,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":49},"100574863","association-between-motor-skills-and-sensory-profiles-in-children-with-typical-and-atypical-development-aged-4-to-11-years-100574863","NCT06764810","Association Between Motor Skills and Sensory Profiles in Children With Typical and Atypical Development Aged 4 to 11 Years","Association Between Motor Skills and Sensory Profiles in Children With Typical and Atypical Development Aged 4 to 11 Years: A Cross-Sectional Observational Case-Control Study","MOTISEN","Inclusion Criteria:\n\n* Children aged 4 to 11 years.\n* Typical or atypical neurodevelopment, defined as follows:\n* ASD: Subclinical symptoms or Level 1 diagnosis.\n* ADHD: Predominantly inattentive, hyperactive\u002Fimpulsive, or combined presentation. For children under 6, typical symptoms of the disorder (e.g., impulsivity, hyperactivity).\n* DCD: Diagnosed or meeting the following criteria:\n\n  * Motor skills below age expectations.\n  * Significant impact on daily activities or school performance.\n  * Difficulties not attributable to another condition.\n* Parental\u002Flegal guardian consent.\n\nExclusion Criteria:\n\n* Moderate to severe intellectual disability (IQ ≤ 51).\n* Neurological disorders (e.g., cerebral palsy) or syndromes.\n* Severe visual and\u002For auditory impairments.\n* Severe behavioral disorders.\n* Severe mental health disorders (e.g., depression, severe anxiety).",true,"4 Years","11 Years",{"count":200,"type":22},40,"1 Month","OBSERVATIONAL","Background and Justification Childhood developmental disorders, such as Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), and Developmental Coordination Disorder (DCD), pose significant challenges for children and their families. These disorders impact children's growth and learning, leading to difficulties in key areas such as language, communication, behavior, social interaction, and motor skills. Research in this area is limited, particularly regarding fine and gross motor skills in relation to sensory processing in children with these diagnoses.\n\nHypothesis and Objectives There is an association between motor skills and sensory processing in children aged 4 to 11 years, depending on whether they have typical or atypical neurodevelopment, such as ASD, ADHD, and DCD.\n\nMain Objective:\n\nTo evaluate the association between motor skills and sensory processing in children aged 4 to 11 years with either typical or atypical neurodevelopment (e.g., ASD, ADHD, and DCD).\n\nSecondary Objectives:\n\nTo describe and compare motor skills among children aged 4 to 11 years with typical or atypical neurodevelopment, such as ASD, ADHD, and DCD.\n\nTo describe and compare sensory processing among children aged 4 to 11 years with typical or atypical neurodevelopment, such as ASD, ADHD, and DCD.\n\nMethodology The study is a cross-sectional observational case-control study. Participants are users of the Child Development and Early Intervention Center (CDIAP) Tris Tras, Neuro Xics, or Criv in Vic.\n\nThe sample will include 30 children as controls (typical neurodevelopment) and 10 children as cases (atypical neurodevelopment: ASD, ADHD, DCD).\n\nChildren will be assessed using the Infant Motor Profile (IMP) to measure motor development and the Short Sensory Profile-2 (SSP-2) to evaluate sensory processing.\n\nStatistical Analysis Quantitative variables will be described using means and standard deviations, while categorical variables will be presented as frequencies and percentages. Statistical tests such as the Student's t-test will be used to compare means between two groups, ANOVA for comparisons among more than two groups, and the Chi-square test to analyze associations between categorical variables.\n\nExpected Results The study is expected to provide essential insights into the differences in motor development between children with typical and atypical neurodevelopment, as well as the relationship between biological and external factors and these differences. These findings could help improve clinical and educational interventions for these children by tailoring them to their specific needs, thereby enhancing their overall well-being and development.\n\nEthical Considerations The study protocol will be submitted to the Research Ethics Committee (CER) of UVic-UCC, adhering to good clinical practice guidelines in accordance with the Declaration of Helsinki. Participants will be assigned a code to ensure data pseudonymization, with data securely stored on the Microsoft 365 server of UVic-UCC. Participants will have the right to withdraw from the study at any time, and personal data will be deleted once the study is completed.\n\nResearchers will ensure confidentiality as dictated by Organic Law 3\u002F2018 of December 5 on the Protection of Personal Data and Guarantee of Digital Rights, Regulation (EU) 2016\u002F679 of April 27, 2016, on data protection, and complementary regulations, as well as Organic Law 1\u002F1982 of May 5 on the right to honor, personal and family privacy, and self-image.",[205,206,207,28,208],"Developmental Disability","Autism Spectrum Disorder","Development Coordination Disorder","Typical Development",[210,211,212,213],"motor skills disorders","physical therapy modalities","pediatrics","child development","2025-01-09",{"date":216,"type":41},"2025-01-13",{"date":218,"type":41},"2024-12-01",{"date":220,"type":22},"2026-12-20",{"name":222,"class":72},"University of Vic - Central University of Catalonia",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":231,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":235,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":49},"100512792","phase-2-lisdexamphetamine-vs-methylphenidate-for-pediatric-patients-with-adhd-and-type-1-diabetes-100512792","NCT05957055","Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes","LAMAinDiab - Lisdexamphetamine Vs Methylphenidate for Pediatric Patients with ADHD and Type 1 Diabetes - a Randomized Cross-over Clinical Trial","LAMAinDiab","Principal inclusion criteria:\n\n* Age 8-16.5 years at study entry;\n* T1D diagnosed on the basis of clinical features, presence of autoantibodies typical for type 1 diabetes (at least one of the following: anti-glutamate decarboxylase, islet cell antibody, insulin autoantibody\u002Fislet antigen 2 autoantibody, zinc transporter 8 antibody) and\u002For low C-peptide levels (according to the laboratory standard appropriate for the assay method) and criteria for the diagnosis of diabetes according to the criteria of the Polish Diabetes Association and international societies:\n\n  * an incidental glycemia ≥200mg\u002Fdl and symptoms of hyperglycemia (such as increased thirst, polyuria, weakness) or\n  * two times a fasting blood glucose ≥125mg\u002Fdl or\n  * a blood glucose ≥200mg\u002FdL in the 120th minute of an oral glucose load test or\n  * HbA1c ≥6.5%.\n* T1D diagnosed at least 12 months before recruitment;\n* T1D treated with functional intensive insulin therapy\n* a diagnosis of ADHD according to Diagnostic and Statistical Manual 5 (DSM-5) criteria confirmed by a psychiatrist or a diagnosis of ADHD according to other criteria recognized in Poland, confirmed by an authorized person as consistent with DSM-5\n* Polish citizenship and Polish health insurance\n\nPrincipal exclusion criteria:\n\n* Daily insulin dose\\\u003C0.3 j\u002Fkg and concomitant HbA1c measurement ≤6.5% from the last 3 months (clinical partial remission of T1D);\n* Severely unsatisfactory glycemic control - mean HbA1c over the past year ≥12% (not including HbA1c measurement at diagnosis of T1D);\n* Diagnosed intellectual or other disability that prevents participation in the trial or adherence to its therapeutic regimen;\n* Clinically apparent cardiovascular disease: recognized hemodynamically significant heart defect, advanced vascular atherosclerosis;\n* Diagnosis of other mental illness or disorder preventing participation in the trial, e.g. bipolar affective disorder, schizophrenia, other psychotic disorders, psychoactive substance abuse;\n* Diagnosed allergy or hypersensitivity to drugs used in pharmacological intervention -methylphenidate and\u002For lisdexamphetamine;\n* Language barrier making it impossible to conduct a full psychological consultation in Polish;\n* Lack of permanent residence in Poland;\n* Contraindications as reported for investigated drugs: documented hypertension (at least stage 2), positive family history for sudden cardiac deaths and atrial arrythmias in relatives below 40 y.o., clinically evident glaucoma or abnormally elevated intraocular pressure, history of suicide attempts or present suicide intentions, oppositional defiant disorder, chronic motor tics or Tourette syndrome, pregnancy or breastfeeding, short stature, underweight (≤ 3rd percentile for reference percentile charts), epilepsy, pheochromocytoma, substance abuse or positive drug test results, prolonged treatment with sedative drugs (e.g., 1st generation antihistamines);\n* Declared by the parents\u002Flegal guardians' inability or unwillingness to come to the Center at the time specified by the protocol, in particular - to pick up the Trial drugs at the dose adjustment stage (the need to pick up 4-5 times over 6-8 weeks, each time within 2-3 days of receiving the recommendations);\n* Other reasons that, in the opinion of the attending physician, are more likely to result in difficulties in maintaining the continuity of the participant's participation in the trial or harm to the participant's health in case of participation in the trial.","8 Years","198 Months",{"count":234,"type":22},150,[236],"PHASE2","This clinical trial aims to evaluate the safety and effectiveness of an intervention involving parental training in behaviour management and medication in children with both Type 1 Diabetes (T1D) and Attention Deficit Disorder with Hyperactivity (ADHD). ADHD is a neurodevelopmental disorder that affects around 5% of school-age children and adolescents, while T1D is a chronic disease requiring strict management.\n\nAfter initial parental training provided for parents\u002Flegal guardians, the children will be randomized to one of two cross-over groups, and treated with either lisdexamfetamine or methylphenidate first. After dose optimization for first 5-7 weeks, patients will be treated for 6 months total, after which they will be switched to the other drug.\n\nResearchers will then compare the ADHD symptom severity as measured by Conners 3 questionnaire, and compare the frequency of any adverse events associated with the therapy. As secondary outcomes, patient's T1D control and quality of life will be compared between the two drugs.",[30,239],"Diabetes Mellitus, Type 1",[241,242,243,244,245,246,247,248,249],"attention deficit disorder with hyperactivity","diabetes mellitus, type 1","methylphenidate","lisdexamfetamine dimesylate","adolescent","child","glycemic variability","randomized cross-over trial","continuous glucose monitoring","2024-11-26",{"date":252,"type":41},"2024-11-29",{"date":254,"type":41},"2024-02-05",{"date":256,"type":22},"2027-12-01",{"name":258,"class":72},"Medical University of Lodz",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":266,"maxAge":134,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":4},"100402342","effectiveness-and-security-testing-of-a-mobile-app-100402342","NCT04519008","Effectiveness and Security Testing of a Mobile App","Effectiveness and Security Testing of a Mobile App (B·RIGHT) for Adolescents With Attention-Deficit\u002FHyperactivity Disorder and Emotion Dysregulation","Inclusion Criteria:\n\n* DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) of attention-deficit\u002Fhyperactivity disorder\n* High emotion dysregulation severity\n* Aged 14 to 17 years\n* Outpatient setting (Consorci Sanitari del Maresme\n\nExclusion Criteria:\n\n* Comorbidity with mental retardation\n* Comorbidity with psychotic disorder\n* Comorbidity with autism spectrum disorder","14 Years",{"count":268,"type":22},80,[25],"To assess the effectiveness and security of a mobile App (beta version) for self-managing emotion dysregulation in a pragmatic randomized controlled trial with 80 adolescents with attention-deficit\u002Fhyperactivity disorder comparing 40 patients with treatment as usual (TAU) with 40 patients with TAU plus the mobile App",[28],"2024-09-12",{"date":274,"type":41},"2024-09-19",{"date":276,"type":22},"2026-10-01",{"date":278,"type":22},"2028-09-15",{"name":280,"class":72},"Consorci Sanitari del Maresme",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":291,"conditions":292,"keywords":293,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":49},"100282072","phase-4-methylphenidate-in-adults-with-attention-deficithyperactivity-disorder-100282072","NCT02951754","Methylphenidate in Adults With Attention Deficit\u002FHyperactivity Disorder","Inclusion Criteria:\n\n* White Brazilian of European descent\n* Fulfillment of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, (DSM-IV) diagnostic criteria for ADHD\n* Eligibility to immediate-release MPH (IR-MPH) treatment\n\nExclusion Criteria:\n\n* Contraindication for IR-MPH use\n* Current stimulant treatment\n* Evidence of a clinically significant neurological disease that might affect cognition (e.g., delirium, dementia, epilepsy, head trauma, and multiple sclerosis)\n* Current or past history of psychosis\n* Estimated intelligence quotient score lower than 70",{"count":288,"type":22},600,[290],"PHASE4","Methylphenidate (MPH) is the first-line pharmacological treatment for adults with Attention-Deficit\u002FHyperactivity Disorder (ADHD). Nevertheless, there is considerable interindividual variability regarding the dose required, tolerability and response rates to MPH. The aim of this study is to address the clinical and genetic predictors of MPH treatment outcomes in ADHD.",[28],[34,294,169,295],"Adults","Methylphenidate","2016-10-31",{"date":298,"type":22},"2016-11-01",{"date":300,"type":4},"2002-02",{"date":302,"type":22},"2032-12",{"name":304,"class":72},"Hospital de Clinicas de Porto Alegre"]