[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Gitte Moos Knudsen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":81},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100308027","phase-1-the-neurobiological-effect-of-5-ht2ar-modulation-100308027",false,"NCT03289949","The Neurobiological Effect of 5-HT2AR Modulation","NeuroPharm2","Inclusion Criteria:\n\n1\\) Healthy individuals above 18 years of age.\n\nExclusion Criteria (For Subprojects 1, 2a, 2b, and 3):\n\n1. Presence of or previous primary psychiatric disease (DSM axis 1 or WHO ICD-10 diagnostic classifications) or in first-degree relatives.\n2. Previous or present neurological condition\u002Fdisease, significant somatic condition\u002Fdisease or intake of drugs suspected to influence test results.\n3. Non-fluent Danish language skills.\n4. Vision or hearing impairment.\n5. Previous or present learning disability.\n6. Pregnancy.\n7. Breastfeeding.\n8. Contraindications in regard to MRI scanning.\n9. Alcohol or drug abuse.\n10. Allergy to test drugs.\n11. Participation in studies in which participant has received more than 10 mSv of radiation or other significant exposure to radiation.\n12. Abnormal ECG or intake of QT prolonging medication.\n13. Previous significant side-effects in regard to hallucinogenic drugs.\n14. Use of hallucinogenic drugs 6 months previous to inclusion.\n15. Blood donation 3 months before and after project participation\n16. Body weight under 50 kg.\n17. Plasma ferritin levels outside normal range\n\nExclusion Criteria (For Subproject 2c):\n\n1. Presence of or previous primary psychiatric disease (DSM IV axis 1 or WHO ICD-10 diagnostic classifications).\n2. Presence of or previous primary psychiatric disease with psychosis symptoms or hypomania (DSM IV axis 1 \\[drug\u002Falcohol abuse\u002Fdependence, schizophrenia and other psychoses\\] or WHO ICD-10 diagnostic classifications \\[F10-29, as well as F30-39 with psychotic symptoms, F60\\]) in first-degree relatives (parents or siblings).\n3. Previous or present neurological condition\u002Fdisease, significant somatic condition\u002Fdisease or intake of drugs suspected to influence test results.\n4. Non-fluent Danish language skills or pronounced vision or hearing impairment.\n5. Previous or present learning disability.\n6. Pregnancy.\n7. Breastfeeding.\n8. Contraindications in regard to MRI scanning.\n9. Alcohol or drug abuse.\n10. Allergy to test drugs.\n11. Abnormal ECG or intake of QT prolonging medication.\n12. Previous significant side-effects in regard to hallucinogenic drugs.\n13. Previous use of hallucinogenic drugs.\n14. Body weight under 45 kg.\n15. Ethical concerns regarding the administration of a psychedelic drug.",true,"ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The investigators wish to investigate neurobiological effects of serotonin 2A receptor modulation in healthy volunteers, contrasting effects of an agonist (psilocybin) and an antagonist (ketanserin). Magnetic resonance imaging (MRI) and positron emission tomography (PET) will be used as neuroimaging tools.",[27],"Basic Science","RECRUITING","2024-12-13",{"date":31,"type":32},"2024-12-16","ACTUAL",{"date":34,"type":32},"2017-03-03",{"date":36,"type":21},"2030-06-01",{"name":38,"class":39},"Gitte Moos Knudsen","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":16,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":40},"100473894","precision-medicine-in-the-treatment-of-epilepsy-100473894","NCT05450822","Precision Medicine in the Treatment of Epilepsy","The BrainDrugs-Epilepsy Study: A Prospective Open-label Cohort Precision Medicine Study in Epilepsy","BDE","Inclusion Criteria for healthy subjects:\n\n* No history of current or past psychiatric or other major medical conditions\n\nExclusion Criteria for healthy subjects:\n\n* Current or previous neurological disease, severe somatic disease, or consumption of medical drugs likely to influence the test results\n* Non-fluent in Danish or pronounced visual or auditory impairments\n* Current or past learning disability\n* Pregnancy or lactation (females)\n* Participation in experiments with radioactivity (\\>10 mSv) within the last year or significant occupational exposure to radioactivity\n* Contraindications for MRI (pacemaker, metal implants, etc.)\n* Severe head injury\n* Alcohol or drug abuse\n* Drug use other than tobacco and alcohol within the last 30 days\n* Hash \\> 50 x lifetime\n* Drugs \\> 10 x lifetime (for each substance)\n* Current psychoactive medication\n* Any current or former primary psychiatric disorder (Axis I WHO ICD-10 diagnostic classification)\n\nInclusion Criteria for patients:\n\n* Cohort I-II: Age between 16 and 55 years\n* Cohort III: Age between 18 and 55 years\n* Cohort I: Semiology of first seizure raises a strong suspicion of epilepsy but do not fulfill International League Against Epilepsy (ILAE) diagnostic criteria\n* Cohort II-III: Diagnosed with epilepsy according to ILAE criteria\n* Cohort III: Epileptogenic lesion on MRI concordant with seizure semiology and\u002For EEG\n\nExclusion criteria for patients:\n\n* Cohort I-III: Life expectancy \\\u003C 10 years\n* Cohort I-III: Known genetic syndromes, psychomotor retardation or disease associated with gross morphological brain changes such as brain tumor, major stroke or major traumatic brain injury\n* Cohort I-III: Body weight less than 40 kg\n* Cohort I-III: Reduced kidney function (i.e., glomerular filtration rate (GFR) \\\u003C 80 ml\u002Fmin or 50 ml\u002Fmin for patients 16-17 years old or ≥18 years old, respectively),\n* Cohort I-III: Moderate reduced liver function\n* Cohort I-III: Cardiac conduction disorders (e.g., Brugada syndrome, long QT-syndrome)\n* Cohort I-III: Medication incompatible with study aims or causing interactions with the administered levetiracetam or lamotrigine therapy (e.g., SV2A binding agents, monoamine oxidase inhibitors, fluvoxamin, methotrexate, benzodiazepines, phenobarbital, carbamazepine, valproate, regular use of other ASMs)\n* Contraindication for MRI (e.g., magnetic implants, pacemaker)\n* Inability to complete PET (Cohort III) or MRI scans (Cohort I-III) (e.g., claustrophobia, issues with back pain)\n* Cohort III: Exposure to radioactivity \\>10 mSv within the last year or significant occupational exposure to radioactivity\n* Pregnancy or lactation\n* Cohort I-III: Non-fluency in Danish or pronounced visual or auditory impairments or severe intellectual disability\n* Cohort I-III: Current or previous alcohol or drug abuse","16 Years","55 Years",{"count":52,"type":21},550,"OBSERVATIONAL","Primary objectives:\n\nThe purpose of this study is to identify single and composite biomarkers (from neuroimaging, electrophysiological, and non-imaging biological measures), clinical measures (from cognitive, psychometric, and behavioral test scores), and risk\u002Fprotective factors (e.g., from medical history, socioeconomic status, coping, lifestyle) that can:\n\n1. Predict antiseizure medication (ASM) treatment outcome, psychiatric, cognitive, or behavioral comorbidities, and quality of life in newly diagnosed epilepsy patients (Cohort II-III).\n2. Predict a second epileptic seizure\u002Fepilepsy diagnosis and behavioral, cognitive, psychiatric dysfunction and quality of life in patients after a first epileptic seizure (Cohort I).",[56],"Epilepsy",[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72],"epilepsy","precision medicine","treatment targets","biomarkers","high density EEG","gut microbiome","longitudinal","levetiracetam","lamotrigine","neuroimaging","machine learning","treatment response","PET","MRI","Psychometrics","2024-04-09",{"date":75,"type":32},"2024-04-11",{"date":77,"type":32},"2022-02-18",{"date":79,"type":21},"2031-12-31",{"name":38,"class":39},""]