[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100346694":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":47,"responsibleParty":70,"collaborators":74,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":79,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":41,"studyType":91,"phases":92,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":49,"whyStopped":41,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Cromoglycate","ACTIVE_COMPARATOR","Cromoglycate nasal spray",[13,14],"Drug: Cromoglycate","Drug: Placebo",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo","PLACEBO_COMPARATOR","Saline nasal spray",[13,14],[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Cromoglycate will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg\u002Fspray",[9,16],[26],"NasalCrom",{"type":22,"name":16,"description":28,"armGroupLabels":29,"otherNames":30},"Normal saline nasal spray will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg\u002Fspray)",[9,16],[31],"Saline Nasal Spray",[33],{"name":34,"affiliation":5,"role":35},"Vishwajit L. Nimgaonkar, M.D., Ph.D.","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Vishwajit L Nimgaonkar, M.D., Ph.D.","CONTACT","(412) 246-6353",null,"vishwajitNL@upmc.edu",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Maribeth A Wesesky, BPS","(412) 310-3108","weseskyma@upmc.edu",[48],{"facility":5,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Pittsburgh","Pennsylvania","15213","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-79.99589,40.44062,{"lat":59,"lon":58},[62,64,67,69],{"name":44,"role":39,"phone":63,"phoneExt":41,"email":46},"412-310-3108",{"name":65,"role":66,"phone":41,"phoneExt":41,"email":41},"Satish Iyengar, Ph.D.","SUB_INVESTIGATOR",{"name":68,"role":66,"phone":41,"phoneExt":41,"email":41},"Konasale Prasad, M.D.",{"name":44,"role":66,"phone":41,"phoneExt":41,"email":41},{"type":71,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"SPONSOR_INVESTIGATOR","Vishwajit Nimgaonkar, MD PhD","Professor",[75],{"name":76,"class":6},"Stanley Medical Research Institute","100346694","phase-1-cromoglicate-adjunctive-therapy-for-outpatients-with-schizophrenia-100346694",false,"NCT03794076","Cromoglicate Adjunctive Therapy for Outpatients With Schizophrenia","Cromoglicte Adjunctive Therapy for Outpatients With Schizophrenia","CATOS","Inclusion Criteria:\n\n* Written informed consent.\n* Both genders, ages 18-60 years\n* Schizophrenia \u002F schizoaffective disorder (DSM V).\n* Treated with the same APD for at least 60 days; Stable dose of APD for \\> 1 month, continued throughout the study.\n* PANSS total score of 60 and Score 4 or more on one or more items of the 'positive' syndrome items (P1-P7)\n* Preference for patients with duration of psychosis less than 7 years.\n\nExclusion Criteria:\n\n* No illicit substance use in last 30 days\u002Fno dependence in 6 months with the exception of methadone treatment for opioid withdrawal.\n* History or current medical \u002Fneurological illnesses that may lead to an unstable course with the exception of epilepsy which is well-controlled on an antiepileptic medication for at least 6 months.\n* Pregnancy.\n* History of immune disorders, HIV infection, or receiving immune-suppressants or immuno-modulators, e.g., steroids.\n* Current or prior treatment with CGY or History of hypersensitivity to CGY.\n* Intellectual disability as defined in DSM V.","ALL","18 Years","65 Years",{"count":89,"type":90},160,"ESTIMATED","INTERVENTIONAL",[93,94],"PHASE1","PHASE2","This is a double blind adjunctive randomized controlled trial for schizophrenia using cromoglicate.",[97,98],"Schizophrenia","Schizo Affective Disorder",[100,101,102],"schizophrenia","schizoaffective disorder","cromoglicate","2026-03-16",{"date":105,"type":106},"2026-03-19","ACTUAL",{"date":108,"type":106},"2019-04-01",{"date":110,"type":90},"2028-06",{"name":72,"class":6},1]