[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Indrit Begue\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100542334","brain-circuitry-therapeutics-for-schizophrenia-100542334",false,"NCT06341517","Brain Circuitry Therapeutics for Schizophrenia","Brain Circuitry Therapeutics for Schizophrenia - A Cross-species Longitudinal Randomized Controlled Clinical Study to Treat Negative Symptoms of Schizophrenia Using Non-invasive Stimulation of the Cerebellum","ATHENA","Inclusion Criteria:\n\n* Inclusion criteria\n\n  * Capable of giving informed consent as evaluated by the treating psychiatrist\n  * Informed Consent signed by the subject\n  * Patients aged 18 - 65 years diagnosed with a schizophrenia spectrum disorder (including schizophrenia, schizoaffective or non-organic psychosis, psychotic disorder NOS) according to DSM-5 criteria\n  * Clinically stable condition judged by their treating psychiatrist\n  * Background antipsychotic medication treatments have remained unchanged for at least 4 weeks\n  * No hospitalization in acute psychiatry ward at least 3 months prior to study entry\n\nSpecific exclusion criteria related to psychopathology\n\n* Comorbid and clinically active current major depressive episode determined by the treating psychiatrist.\n* Active psychotic symptoms. In particular, patients that at Baseline have a PANSS scores of more than 4 in any of the following PANSS items: delusions, suspiciousness\u002Fpersecution and hallucinatory behaviour will be considered not stable enough to participate.\n* Significant extrapyramidal side-effects quantified by total score of mSAS \\> 12.\n* Increased sedation due to use of medication (slowing, drowsiness, slurred speech etc.)\n* Active daily use of substances (i.e. cocaine), including for therapeutically medical purposes (e.g., methadone substitution)\n\nExclusion criteria related to MRI or TMS\n\n* History of fainting spells of unknown or undetermined aetiology that might constitute seizures\n* History of multiple seizures or diagnosis of epilepsy\n* Any progressive (e.g., neurodegenerative) neurological disorder such as multiple sclerosis or Parkinson's disease\n* Chronic uncontrolled medical conditions that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc.)\n* Metallic objects\u002Fimplants (excluding dental fillings) unless cleared to be MRI compatible (i.e. MRI compatible joint replacement)\n* Any implants controlled by physiological signs in\u002Fnear the head\n\n  * Pacemaker\n  * Implanted medication pump\n  * Vagal nerve stimulator\n  * Deep brain stimulator or TENS unit\n  * Ventriculo-peritoneal shunt\n  * Cochlear implant\n* Impaired ability to sense heat\u002Fpain, open wounds etc.\n* Increased intracranial pressure\n* Intracranial lesion, from a known genetic disorder or from acquired neurologic disease (e.g. stroke, tumor, cerebral palsy, severe head injury, or significant dysmorphology).\n* History of head injury resulting in prolonged loss of consciousness (\\>15minutes) or neurological sequelae\n* Ongoing pregnancy and breastfeeding. All participants capable of becoming pregnant will be required to have active contraception; any participant who is pregnant or breastfeeding will not be enrolled in the study.\n\nOther exclusion criteria\n\n* Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, cancer, pulmonary decompensation etc.)\n* Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, intellectual retardation, dementia, etc. of the subject\n* Having legal obligation for psychiatric treatment.\n* Participation in another investigation with an investigational drug or another MD within the 30 days preceding and during the present investigation.\n* Previous enrolment into the current investigation\n* Enrolment of the PI, his\u002Fher family members, employees and other dependent persons.","ALL","18 Years","65 Years",{"count":21,"type":22},70,"ESTIMATED","INTERVENTIONAL",[25],"NA","This project is a double blind randomized clinical trials that examines the efficacy of cerebellar non invasive stimulation for apathy improvement in patients with schizophrenia",[28],"Schizophrenia; Psychosis","RECRUITING","2024-11-14",{"date":32,"type":33},"2024-11-19","ACTUAL",{"date":35,"type":33},"2024-04-15",{"date":37,"type":22},"2027-12-12",{"name":39,"class":40},"Indrit Begue","OTHER",2,""]