[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561774":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":25,"responsibleParty":36,"collaborators":25,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":25,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":58,"whyStopped":25,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":25},{"fullName":5,"class":6},"Assistance Publique - Hôpitaux de Paris","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Sulforaphane","EXPERIMENTAL","Prostaphane® is a dietary supplement based on SULFODYNE®, a broccoli seed extract standardised in free, stabilised sulforaphane.\n\nPatients will receive treatment for 8 weeks at the following dosage:\n\n* 1 capsule\u002Fday up to 50 kg,\n* 2 capsules\u002Fday from 50.1 to 90 kg;\n* 3 capsules\u002Fday above 90 kg,\n\nEach capsule contains 10mg of Sulforaphane.",[13],"Dietary Supplement: Sulforaphane",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Patients will receive treatment for 8 weeks at the following dosage:\n\n* 1 capsule\u002Fday up to 50 kg,\n* 2 capsules\u002Fday from 50.1 to 90 kg;\n* 3 capsules\u002Fday above 90 kg,\n\nEach capsule contains placebo.",[19],"Other: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","taken once a day (one to three capsules a day depending on the patient's weight) for 8 weeks of Sulforaphane",[9],null,{"type":6,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"taken once a day (one to three capsules a day depending on the patient's weight) for 8 weeks of placebo",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Eric ACQUAVIVA, PhD","CONTACT","0140034092","+33","eric.acquaviva@aphp.fr",{"type":37,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100561774","study-of-the-efficacy-of-sulforaphane-in-children-aged-6-to-12-with-attention-deficit-disorder-with-or-without-hyperactivity-100561774",false,"NCT06594536","Study of the Efficacy of Sulforaphane in Children Aged 6 to 12 With Attention Deficit Disorder With or Without Hyperactivity","SulfoTDAH","Inclusion Criteria:\n\n* Children aged 6 to 12\n* Diagnosis of ADHD according to DSM-5 criteria (Diagnostic and Statistical Manual of Mental Disorders)\n* Followed or hospitalised in an investigating centre\n* Consent of holders of parental authority\n* Patient covered by health insurance (social security or CMU)\n* Patients able to swallow capsules\n\nExclusion Criteria:\n\n* Allergy to broccoli\n* Psychotropic treatment including methylphenidate in the month prior to inclusion\n* Ongoing psychotherapeutic and\u002For psycho-educational treatment specific to ADHD\n* ASD (Autism Spectrum Disorder) according to DSM-5 criteria, intellectual disability (IQ\\\u003C 80)\n* Chronic neurological disease, epilepsy\n* Holders of parental authority under guardianship or curatorship\n* Previous intake of sulforaphane\n* Known hypothyroidism or current thyroid treatment\n* Participation in other interventional research involving the human person or being within the exclusion period following previous research involving the human person, where applicable\n* Patient under AME (state medical aid)","ALL","6 Years","12 Years",{"count":49,"type":50},70,"ESTIMATED","INTERVENTIONAL",[53],"NA","ADHD is a neurodevelopmental disorder. It is the most common neurodevelopmental disorder in children and adolescents. Its prevalence is estimated at 5.9% in this population. The symptoms of ADHD combine attention deficit with behavioural disorders such as hyperactivity and impulsivity. Current treatment for ADHD is based on psychotherapeutic and psychoeducational measures aimed at improving behaviour and its impact on the family, social and school environment. Drug treatments may also be used, depending on the impact of the disorder and the effectiveness of alternative treatments. Psychostimulants such as amphetamine derivatives and methylphenidate are around 80% effective.\n\nSulforaphane is an active substance derived from broccoli that has already been tested in the treatment of other neurodevelopmental disorders. The main hypothesis is that sulforaphane is effective in treating the symptoms of Attention Deficit Disorder with or without Hyperactivity (ADHD) in children.",[56],"Attention Deficit Disorder",[9],"NOT_YET_RECRUITING","2024-09-10",{"date":61,"type":62},"2024-09-19","ACTUAL",{"date":64,"type":50},"2024-12-01",{"date":66,"type":50},"2026-09-01",{"name":5,"class":6}]