[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autism-spectrum-disorder-high-functioning\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autism-spectrum-disorder-high-functioning":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100515150","prt-for-adolescents-with-high-functioning-autism-100515150",false,"NCT05987761","PRT for Adolescents With High Functioning Autism","Pivotal Response Treatment for Adolescents With High Functioning Autism Intervention Study","Inclusion Criteria:\n\n* Clinical Diagnosis of Autism Spectrum Disorder, higher functioning\u002Flow support needs\n* Intelligence Quotient (IQ): Participants with a Full Scale IQ \\> 80 on the Wechsler Abbreviated Scale of Intelligence (WASI-II)\n* Right-handed\n* No metal in their body\u002Funremovable metal on their body (i.e., braces)\n* First language is English\n* Must live in the San Francisco Bay Area\n* Able and willing to receive intervention weekly for 9 weeks\n* Adolescent is interested in improving their social skills\n* MRI Compatibility: No major contraindication for MRI.\n* Diagnosis of ASD using ADOS-2 and ADI-R.\n* No evidence of a genetic, metabolic, or infectious etiology for their autism.\n* Primary diagnosis of ASD\n* No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period.\n* Stable treatment (e.g., ABA), speech therapy, school placement, psychotropic medication(s) or biomedical intervention(s) for at least 1 month prior to baseline measurements with no anticipated changes during study participation.\n* Score of at least 50% or below on at least 4 out of the 9 social target areas in the SLO (administered during pre-measures)\n* No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period.\n\nExclusion Criteria:\n\n* History of claustrophobia, previous head injury, serious neurological or medical illness, birth weight less than 4 lb. and\u002For gestational age \\\u003C 34 weeks\n* Left-handed\n* Braces or any metal in their body","ALL","11 Years","14 Years",{"count":20,"type":21},76,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to identify improvement in behavioral and social function and changes in the brain following Pivotal Response Treatment (PRT) for Adolescents in highly verbal adolescents with autism spectrum disorder (ASD).",[27,28,29,30,31,32],"Autism","Autism Spectrum Disorder High-Functioning","Developmental Disability","Child Development","Behavior, Child","Behavior, Social",[27,34,35,36,37,38,39],"Autism Spectrum Disorder","PRT","Pivotal Response Treatment","Autism intervention","Social skills","Adolescents","RECRUITING","2024-03-26",{"date":43,"type":44},"2024-03-28","ACTUAL",{"date":46,"type":44},"2023-09-01",{"date":48,"type":21},"2026-08-31",{"name":50,"class":51},"Stanford University","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":75,"leadSponsor":77,"locationsCount":52},"100530462","the-supplementation-therapy-in-autism-and-response-to-treatment-study-100530462","NCT06187090","The Supplementation Therapy in Autism and Response to Treatment Study","The Supplementation Therapy in Autism and Response to Treatment (START) Study","START","Inclusion Criteria:\n\n* Individuals diagnosed with Level 1 ASD, as defined using Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5);\n* Aged 18-35 years;\n* To be able to understand and communicate in Italian;\n* To be able to give informed consent.\n\nExclusion Criteria:\n\n* Level 2 or Level 3 ASD, as defined using Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) \\[47\\];\n* Current diagnosis of a co-occurring major psychiatric disorder (e.g., major depressive disorder, bipolar affective disorder, psychotic disorders);\n* Active suicidal ideation indicating significant current risk or history of serious suicide attempt in the opinion of the PI, as evaluated at the screening stage;\n* Lifetime neurological disorders (e.g., epilepsy, except febrile convulsions) or severe intercurrent physical illness;\n* Current treatment with psychotropic medication, with the exception of Selective Serotonin Reuptake Inhibitor (SSRI) stable monotherapy (at least 8 months);\n* IQ \\\u003C 70;\n* Female patients who are pregnant, lactating or not using an acceptable effective form contraception if they are at risk of falling pregnant;\n* Taking part in another pharmacological trial.","18 Years","35 Years",{"count":64,"type":21},20,[24],"In addition to the \"core\" symptoms of ASD (i.e., impaired communication, impaired reciprocal social interaction and restricted, repetitive and stereotyped patterns of behaviors or interests), it is estimated that up to 70% of autistic people present at least one comorbid psychiatric disorder, leading to a deterioration in quality of life, a greater demand for support and worse prognosis and outcome. Anxiety and depressive symptoms would seem to be more present in individuals with Level 1 ASD, requiring their prioritisation against core symptoms. To date, the first-line treatment for autistic patients with comorbid depressive and\u002For anxiety symptoms is still debated and it is not always clear whether they may or may not benefit from psychotherapeutic and conventional psychopharmacological approaches. As such, growing evidence strengthens the therapeutic potential of the endocannabinoid (eCB) system modulation and of eCB-like compounds.\n\nThe aim of this study is to provide a response to an unmet clinical need in this framework of psychic vulnerability by initiating oral therapy with palmitoylethanolamide (PEA), a nutraceutical\u002Ffood supplement with proven anti-inflammatory and neuroprotective properties.\n\nIndeed, many conditions of psychological distress are thought to be underpinned by systemic inflammatory and\u002For neuroinflammatory processes, on which PEA has shown remarkable efficacy, including through modulation of the immune response and the interaction between the endocannabinoid system and the gut-microbiota-brain axis.\n\nThe trial we are proposing is a 12-week open-label phase 2 study involving the daily intake of PEA 600 mg, at a dosage of 1 tablet\u002Fday.\n\nThis study will be conducted at the Unit of Psychiatry of Santa Maria della Misericordia Udine University Hospital.\n\nThrough this study, we wish to evaluate: the ability of PEA to alleviate symptoms of psychic distress (i.e., anxiety and\u002For depression) in Level 1 autistic adults; the safety and tolerability of sustained intake of PEA in Level 1 autistic adults; and the biological basis of PEA functioning.\n\nThe study involves taking PEA orally once daily (600 mg daily) at the same time as a meal during the initial 12-week phase. Upon completion of the initial phase, subjects will be offered to enter an extension phase of the trial of an additional 24 weeks to assess treatment stability, with the possibility of titration of PEA to 1200 mg daily based on observed clinical compensation. Each participant will be on PEA treatment for up to 36 weeks.\n\nDuring the course of the study, periodic clinical re-evaluations will be conducted at our Day-Hospital setting.\n\nThe trial will unfold through one screening visit, one baseline visit, and two follow-up visits (FUP, 4 weeks and 12 weeks apart). The patient will be administered standardized interviews by a qualified investigating physician; clinical objective examination, collection of blood and urine samples for standard hematochemical investigations, collection of blood and stool samples for analysis of some biological markers of interest, monitoring of adherence to therapy intake, side effects, and adverse effects will also be performed during the follow-up visits. The nutraceutical PEA will be dispensed by the clinical investigators at each follow-up visit.",[27,34,28,68,69,70],"Asperger Syndrome","Depressive Symptoms","Anxiety State","2023-12-15",{"date":73,"type":44},"2024-01-02",{"date":46,"type":44},{"date":76,"type":21},"2026-11",{"name":78,"class":51},"University of Udine"]