[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100371255":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":29,"locations":38,"responsibleParty":72,"collaborators":75,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":26,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":26,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"The Alfred","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Oral Bazedoxifene","EXPERIMENTAL","Oral Bazedoxifene dosed at 40 mg daily",[13],"Drug: Bazedoxifene Acetate",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Identically packaged placebo capsule daily",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Bazedoxifene Acetate","Oral Bazedoxifene dosed at 40 mg daily for 12 weeks",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":28,"otherNames":26},[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":26,"email":34},"Anthony de Castella","CONTACT","+61 390766564","Anthony.decastella@monash.edu",{"name":36,"role":32,"phone":33,"phoneExt":26,"email":37},"MAPrc","maprc@monash.edu",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Multidisciplinary Alfred Psychiatry Research Centre","RECRUITING","Melbourne","Victoria","3004","Australia","AU",{"type":48,"coordinates":49},"Point",[50,51],144.96332,-37.814,{"lat":51,"lon":50},[54,58,63,65,68,70],{"name":55,"role":32,"phone":56,"phoneExt":26,"email":57},"Jayashri Kulkarni, MBBS,MPM,FRANZCP,PhD","+61 3 9076 6924","j.kulkarni@alfred.org.au",{"name":59,"role":32,"phone":60,"phoneExt":61,"email":62},"Anthony deCastella, Dip App Sci, BA, MA","+61 3 9076 6554","66554","anthony.decastella@monash.edu",{"name":55,"role":64,"phone":26,"phoneExt":26,"email":26},"PRINCIPAL_INVESTIGATOR",{"name":66,"role":67,"phone":26,"phoneExt":26,"email":26},"Anthony deCastella, Dip AppSci,BA,MA","SUB_INVESTIGATOR",{"name":69,"role":67,"phone":26,"phoneExt":26,"email":26},"Emorfia Gavrilidis, BAppSci",{"name":71,"role":67,"phone":26,"phoneExt":26,"email":26},"Caroline Gurvich, DPsych FCCN MAPS",{"type":64,"investigatorFullName":73,"investigatorTitle":74,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Jayashri Kulkarni, Professor","Director of Multidisciplinary Alfred Psychiatry research centre",[76],{"name":77,"class":6},"Monash University","100371255","phase-4-bazedoxifene--treatment-for-women-with-schizophrenia-100371255",false,"NCT04113993","Bazedoxifene -Treatment for Women With Schizophrenia","Bazedoxifene - A New Selective Estrogen Receptor Modulator Treatment for Women With Schizophrenia: a Double-blind, Randomized, Placebo Controlled Trial","Inclusion Criteria:\n\n* Physically well.\n* A current DSM-V diagnosis of schizophrenia or related disorder.\n* 18- 65 years\n* Able to give informed consent.\n* PANSS total score between 40 and 90.\n* Documented normal PAP smear and pelvic examination in the preceding two years.\n* Stable psychotropic medication for previous 4 weeks\n* Normal breast screen (for women aged over 40 years)\n* IQ \\> 70 (as determined by the WAIS IV subtests)\n* English language proficiency (in order to provide informed consent and complete cognitive test battery)\n\nExclusion Criteria:\n\n* Patients with known abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event.\n* Patients with a history of severe traumatic brain injury or significant neurological or unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; presence of illness causing immobilisation.\n* Patients whose psychotic illness is directly related to illicit substance use or who have a history of substance dependence during the last six months (with the exclusion of caffeine and\u002For nicotine dependence).\n* Women aged 40 or over who have not had a normal mammogram in the last 24 months\n* Use of any form of estrogen, progestin or androgen as hormonal therapy in preceding 4 weeks including the pill (excluding IUD or Hormone Implants).\n* Pregnant (HCG will be measured at screening)\n* Breastfeeding\n* Planned changes to psychotropic medication or psychotherapy regimen.","FEMALE","18 Years","65 Years",{"count":89,"type":90},160,"ESTIMATED","INTERVENTIONAL",[93],"PHASE4","To study the effect of adjunctive bazedoxifene - a selective estrogen receptor modulator (SERM) in a double blind, placebo-controlled adjunctive study in the treatment of women with schizophrenia. All patients receive standardized antipsychotic medication.",[96,97,98],"Schizophrenia","Schizophreniform Disorders","Schizo Affective Disorder","2026-06-01",{"date":101,"type":102},"2026-06-03","ACTUAL",{"date":104,"type":102},"2019-10-07",{"date":106,"type":90},"2026-12-31",{"name":5,"class":6},1]